Article ID: CR-24-0162
Background: The prevalence of cardiovascular diseases (CVD) is high worldwide. Occupational therapy (OT) allows individuals to participate in activities of daily living (ADLs) and improves their quality of life. However, whether OT improves health-related quality of life (HRQOL), ADLs, fatigue, occupational performance, rehospitalization, and mortality in patients with CVD remains unclear. This study aimed to determine whether OT improves HRQOL, ADLs, fatigue, occupational performance, rehospitalization, and mortality in patients with CVD using a systematic review and meta-analysis.
Methods and Results: A literature search of 3 databases in October 2024 yielded 4 RCTs on OT in CVD patients. Two trials (n=208) assessed HRQOL, while 2 others (n=220) examined ADLs. One trial (n=23) evaluated fatigue and occupational performance, and another (n=93) assessed rehospitalization and mortality. Due to insufficient data on HRQOL and ADL improvement in 1 trial, a meta-analysis was not feasible. Similarly, a meta-analysis of fatigue, occupational performance, rehospitalization, and mortality could not be performed due to the limited number of studies.
Conclusions: The results showed no clear evidence that OT improves HRQOL or ADLs in patients with CVD.
The prevalence of cardiovascular diseases (CVD) is high worldwide,1,2 with ischemic heart disease being the leading cause of death worldwide.3 The number of patients with heart failure is increasing and is projected to increase.4 Patients with CVD often experience shortness of breath, fatigue, and impaired activities of daily living (ADLs),5 leading to frequent readmissions.6
Cardiac rehabilitation (CR) is an effective treatment for patients with CVD.7–11 CR is defined as a comprehensive program designed to optimize the physical, psychological, and social well-being of patients with CVD. CR programs include medical assessments, prescribed exercise training, coronary risk factor modification, patient education, counselling, and optimized medical therapy, provided by a multidisciplinary team.12
The CR team comprises doctors, nurses, physical therapists, and occupational therapists. Intervention by a multi-disciplinary team has a class I of recommendation and a grade A of recommendation.12 The role of occupational therapists in CR is described as exercise training in the CR guideline. On the other hand, the World Federation of Occupational Therapists (WFOT) defines occupational therapy (OT) as a client-centred health profession to promote patient health and well-being through occupation. The primary goal of OT is to enable people to participate in the ADLs. Occupational therapists achieve this outcome by working with patients to enhance their ability to engage in their occupations or modify the occupation or environment to better support their occupational engagement.13 Therefore, the defined roles of OT in the WFOT and the CR guidelines differ. We believe that OT should provide interventions that promote health and well-being through occupation in the field of CR.
However, multiple hypotheses speculating that client-centred OT improves health-related quality of life (HRQOL) in patients with any disease14–19 appear to be unfounded. In addition, whether OT improves HRQOL in patients with CVD remains unclear.
Therefore, we aimed to determine whether OT improves HRQOL and ADLs, fatigue, occupational performance, cardiovascular (cardiac-related) mortality, or cardiac-related rehospitalization in patients with CVD using a systematic review and meta-analysis. We hypothesized that OT improves HRQOL, ADLs, fatigue, occupational performance, cardiovascular (cardiac-related) mortality, or cardiac-related rehospitalization in patients with CVD.
Registration Information This meta-analysis was registered at PROSPERO (registration no. CRD42023438640).
Types of Studies This study included randomized controlled trials (RCTs), regardless of cluster or individual randomization. We excluded manuscripts with only abstracts or unpublished data.
Types of Participants This study included participants diagnosed with CVD, regardless of age, gender, or severity of disease. Only data from patients diagnosed with CVD were considered eligible.
Types of Interventions We defined ‘OT intervention’ as an intervention using OT theory, in which an occupational therapist intervened.
Types of Outcome MeasuresPrimary Outcomes The primary outcome was health-related quality of life as assessed using validated questionnaires.
Secondary Outcomes The secondary outcomes were: ADL; fatigue; occupational performance; and cardiovascular (cardiac-related) mortality or cardiac-related rehospitalization, defined as the total number of rehospitalizations.
Search Methods for Study IdentificationThis study was conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) 2020 statement.20 We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE electronic databases, with no limitations regarding the year of publication or language. All databases were searched in October 2024. Supplementary Appendix shows all the search strategies used.
Furthermore, we conducted a search of ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal (https://trialsearch.who.int) on September 20, 2024.
We searched all databases from their inception to the present, without restrictions on the language of publication or publication status.
Data Collection and AnalysisSelection of Studies Two review authors (T.T., D.T.) independently screened the titles and abstracts of all potentially relevant studies identified using the search and coded them as ‘retrieve’ (eligible or potentially eligible/unclear) or ‘do not retrieve’. In case of disagreements, other review authors were asked to arbitrate (A.T., S.Y.). T.T. and D.T. retrieved the full-text reports/publications, independently screened the full texts, identified studies for inclusion, and identified and recorded reasons for the exclusion of ineligible studies. Any disagreements were resolved through discussion or by consulting other review authors (A.T., S.Y.) when necessary. The review authors identified and excluded duplicates and collated multiple reports of the same study such that each study, rather than each report, was the unit of interest in the review. We recorded the selection process in sufficient detail to complete a PRISMA flow diagram (Figure 1) and a list of characteristics of excluded studies (Supplementary Table 1).
PRISMA flow diagram of the study inclusion process.
Data Extraction and Management
A data collection form that had been piloted on at least 1 study in the review was used to record the study characteristics and outcome data. Two review authors (T.T., D.T.) extracted the characteristics from the included studies.
Assessment of the Risk of Bias in the Included StudiesTwo review authors (T.T., D.T.) independently assessed the risk of bias for each study using the Risk of Bias Tool 2, according to the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions.21 Any disagreements were resolved by discussion with other review authors (A.T., S.Y.) or by contacting the authors of the included studies. We graded each potential source of bias as high, low, or some concerns and provided a quote from the study report with justification for our judgment in the ‘Risk of bias’ table (Figure 2–5).
‘Risk of bias’ summary: review authors’ judgments about health-related quality of life ‘Risk of bias’ item for each included study.
‘Risk of bias’ summary: review authors’ judgments about activities of daily living ‘Risk of bias’ item for each included study.
‘Risk of bias’ summary: review authors’ judgments about fatigue and occupational performance ‘Risk of bias’ item for each included study.
‘Risk of bias’ summary: review authors’ judgments about rehospitalization and mortality ‘Risk of bias’ item for each included study.
T.T. and D.T. each used the five GRADE domains (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of evidence in studies that contribute data to the meta-analyses regarding the prespecified outcomes. We used methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions,22,23 using GRADEpro software (GRADEproGDT 2017). We justified all decisions downgrading the quality of studies using footnotes and added comments to aid readers’ understanding of the review where necessary. A second review author (D.T.) checked the assessment.
Measures of Treatment EffectBinary Data We aimed to analyze binary data as risk ratios (RR), with 95% confidence intervals (CIs); however, no such data was available for analysis.
Continuous Data We aimed to estimate the mean difference (MD) or standardized MD (SMD) for continuous data, with 95% CIs. Nevertheless, if any of the encompassed trials had used scales exhibiting substantial congruence, we would assume a small difference in measurement. Subsequently, we aimed to ascertain the effect size and transmute the effect back to the units corresponding to one or more of the specific instruments. We intended to combine the results of the included studies for each outcome, where appropriate, to provide an overall estimate of the treatment effect. However, a meta-analysis could not be conducted owing to the paucity of studies on the primary and secondary outcomes.
Missing Data We planned to contact investigators or study sponsors to verify key study characteristics and obtain missing numerical outcome data (e.g., when a study was identified as abstract only). Data that could not be verified was thought to introduce serious bias, and we planned to explore the impact of including such studies in the overall assessment of results using sensitivity analysis. However, we could not conduct this analysis owing to the limited number of included trials. The denominator for outcome in each study was the number randomized minus any participants whose outcomes were known to be missing.
Assessment of Heterogeneity We used I2 and Chi2 statistics to measure heterogeneity among the trials in each analysis. We identified and reported substantial heterogeneity (e.g., I2 score of >50% and P<0.05), and planned to explore possible causes using prespecified subgroup analysis. However, we could not conduct subgroup analysis owing to the limited number of included trials.
Assessment of Reporting Biases We planned to create and examine a funnel plot to explore publication bias by visually assessing funnel plot asymmetry if more than 10 trials could be included. However, we could not conduct this analysis owing to the limited number of included trials.
Data Synthesis We conducted meta-analyses only when it was meaningful, that is, when the treatments, participants, and the underlying clinical questions were similar enough to justify pooling. Occupational therapists offer a wide range of therapies; therefore, we made an a priori assumption that any included studies would estimate different, yet related, effects. If we had included any studies in the review, we would have used a random-effects model for all analyses.
Sensitivity Analysis In the meta-analysis of the primary outcome, a sensitivity analysis was planned to be performed if a higher risk of bias in some studies affected the results. We defined ’high risk’ as a study having a high risk in terms of random sequence generation, inadequate allocation concealment, or missing >20% of data.24 We planned to carry out the following sensitivity analyses: only including studies with a low risk of bias; and excluding trials with ≤10 events.
The only relevant studies identified were full-text publications. After removing duplicates, we identified 726 records. We screened titles and abstracts, retrieving 116 full-text articles for further assessment (Figure 1). Of these, we excluded 16 protocol articles, 39 non-randomized studies, 19 studies with inappropriate participants, 34 studies with inappropriate interventions, and 4 studies that did not assess relevant outcomes (Supplementary Table 1).
Included StudiesCharacteristics of the included studies including participant information are presented in Table. We incorporated 4 studies, with a total of 360 participants. All trials were conducted at a single centre. One of the 4 trials that met the inclusion criteria25 focused on 91 community-dwelling women with chronic heart failure, ranging in age of 63–89 years. The intervention involved a multidisciplinary team of physicians, nurses, dietitians, physical therapists, pharmacists, social workers, and occupational therapists (Supplementary Table 2). The intervention included optimization of medical care, including education, counselling, and dietary management, and 12 exercise programs conducted over 6 weeks. The other 2 trials were conducted by occupational therapists and included mental stress reduction therapy,26 a short-term OT intervention27 and Energy Conservation plus Problem-Solving Therapy (EC+PST),28 which involved needs assessment, iatrogenic prevention, ADL retraining, and instructions. In Rosenfeldt et al.’s study, 60 patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery received 2 weeks of mental stress reduction therapy.26 In Abizanda et al.’s study, 58 patients aged ≥65 years with cardiopulmonary disease (primarily chronic obstructive pulmonary disease [COPD] exacerbations, pneumonia, and heart failure) received an average of five 45-min OT interventions per day, Monday through Friday, between 8 a.m. and 3 p.m.27 In Kim’s study, the EC+PST intervention sessions were conducted twice a week for 30–45 min, for up to 12 sessions over a 6-week period, involving 11 residents of a rural area in the southern United States.28 These trials were conducted in Canada, Australia, Spain, and the United States, respectively. However, none of the trials provided information on participant ethnicity.
Characteristics, Interventions, and Outcomes of Included Studies
| Study | Abizanda et al. (2011)27 |
Azad et al. (2008)25 |
Rosenfeldt et al. (2011)26 |
Kim et al. (2019)28 |
|---|---|---|---|---|
| Region | Spain | Canada | Australia | United States |
| Setting | Hospital | Hospital and the community | Hospital | Community |
| Inclusion criteria | Cardiopulmonary disease | CHF | CABG and/or valve surgery | Heart failure |
| Sample size | n=129 OT intervention, n=58 Control group, n=71 |
n=91 Treatment group, n=45 Control group, n=46 |
n=117 Holistic therapy, n=60 Usual care, n=57 |
n=23 EC+PST, n=11 Health education, n=12 |
| Subject, n (% male) |
OT intervention, 18 (31.0) Control group, 25 (35.2) |
No data | Holistic therapy, 47 (78.0) Usual care, 40 (70.0) |
EC+PST, 7 (63.6) Health education, 9 (75.0) |
| Age (years) | OT intervention, 83.4±6.1 CTM, 83.8±5.6 |
Treatment group, 74.20 [63–88] Control group, 75.79 [63–89] |
Holistic therapy, 62.5 [59.0–68.5] Usual care, 57.0 [58.0–77.0] |
EC+PST, 66.9±15.1 Health education, 60.2±15.9 |
| Therapeutic interventionist |
Occupational therapist | Physician Nurse Nutritionist Physical therapist Pharmacist Occupational therapist Social worker |
Occupational therapist Physiotherapist |
Occupational therapist |
| Intervention duration |
Hospitalized | 6 weeks | 2 weeks | 6 weeks |
| Intervention group |
Usual care and occupational therapist intervention |
Optimal medical care and the clinical interdisciplinary intervention pathway |
Light physical exercise sessions together with a mental stress reduction program |
Manage fatigue by applying problem-solving skills to conserve energy |
| Control group | Usual care | Optimal medical care | Usual care | Health education |
| Outcome | Barthel index CAM |
MLHFQ SF-36 MMSE GDS PSMS Survival and health service utilisation over 6 months |
SF-36 LOS AF incidence |
The feasibility of recruiting and retaining participants The feasibility of using a tablet computer The appropriate outcome measures for fatigue and activity participation PROMIS Fatigue 8a Fatigue Impact Scale Activity Card Sort Form B |
| Result | None of the variables reached statistical significance Barthel Index of the OT intervention group adjusted RR for functional recovery was 1.57 (95% CI 1.06–2.32) |
Not significant | Not significant | Reported fatigue was significantly lower for both the EC+PST (P=0.03, r=0.49) and health education (P=0.004, r=0.64) groups. The health education group reported significantly lower fatigue impact (P=0.019, r=0.48). Participation was significantly different in low- physical demand leisure activities (P=0.008; r=0.55), favoring the EC+PST group |
The nominal scales are n (%), median [minimum–maximum or 25–75%]. AF, atrial fibrillation; CABG, coronary artery bypass graft; CAM, confusion assessment method; CHF, chronic heart failure; CI, confidence interval; CTM, conventional treatment model; EC, energy conservation; GDS, 15-item Geriatric Depression Scale; IQR, interquartile range; LOS, length of stay; MLHFQ, Minnesota Living with Heart Failure Questionnaire; MMSE, Mini-Mental State Examination; OT, occupational therapy; PROMIS, Patient-Reported Outcomes Measurement Information System; PSMS, physical self-maintenance scale; PST, problem-solving therapy; RCT, randomised controlled trial; SF-36, Short Form 36-item Health Survey Questionnaire.
Assessment of the Risk of Bias in Included Studies
Risk of bias and evidence certainty assessments are indicated in Figures 2–5. Figure 2 illustrates HRQOL, Figure 3 depicts ADLs, Figure 4 addresses fatigue and occupational performance, and Figure 5 depicts rehospitalization and mortality.
Primary OutcomesHRQOL HRQOL was measured using the 36-item Short Form Health Survey (SF-36) (scored in points)29 and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (scored in points).30 Two trials with HRQOL as an outcome involving 208 participants were included. One trial reported baseline MLHFQ scores but did not report post-intervention scores; therefore, determining the extent of improvement was not possible.25 The second trial reported separate SF-36 scores for the physical and mental composite scores.26 The physical composite score improved by 4.8 points in the usual care group compared with 3.7 points in the OT group; however, this difference was not statistically significant. Similarly, the mental composite score improved by 2.1 points in the OT group compared with 0.9 points in the usual care group, without statistical significance. Overall, the extent of improvement in one of the 2 trials with HRQOL as an outcome was unknown, and a meta-analysis of HRQOL could not be performed owing to the missing data in one of the trials.
Secondary OutcomesADLs ADLs were measured using the Barthel Index (BI)31 and Physical Self-Maintenance Scale (PSMS).32 Two trials with ADL as an outcome involving 220 participants were included. One trial reported baseline PSMS scores but did not report post-intervention scores; therefore, determining the extent of improvement was not possible.25 The second trial reported that BI improved significantly with OT intervention, with a score of 9.5 in the OT group compared with 4.0 in the usual care group.27 Similar to the HRQOL outcome, the 2 trials with ADLs as an outcome had missing data in one of the trials, and a meta-analysis of ADLs could not be performed.
Fatigue Fatigue was assessed using the PROMIS Fatigue 8a and the Fatigue Impact Scale. The only trial that included fatigue as an outcome involved 23 participants.28 In Kim et al.’s study, reported fatigue was significantly reduced in both the EC+PST group (P=0.03; r=0.49) and the Health Education (HE) group (P=0.004; r=0.64). As only 1 study addressed fatigue, a meta-analysis could not be conducted.
Occupational Performance Occupational performance was assessed using the Activity Card Sort Form. The only trial that included occupational performance as an outcome was Kim et al.’s study, which also addressed fatigue and involved 23 participants.28 The study reported a significant improvement in the degree of participation in leisure activities with low physical demand in the EC+PST group (P=0.008; r=0.55). However, since only 1 study evaluated occupational performance as an outcome, similar to fatigue, a meta-analysis could not be conducted.
Rehospitalization and Mortality The only study that included rehospitalization and mortality as outcomes was Azad’s study, which also examined HRQOL and ADL, and involved 23 participants.25 In this study, rehospitalization due to CHF was significantly higher in the treatment group over the 6 months following the intervention, with an average of 0.477 occurrences compared with 0.083 occurrences in the control group (P=0.018). However, no significant difference in mortality was reported between the 2 groups. As only 1 study evaluated rehospitalization and mortality as outcomes, as well as fatigue and occupational performance, a meta-analysis could not be conducted.
This review aimed to determine the effectiveness of OT in individuals with CVD. Three trials met the criteria for inclusion. Our results do not clearly demonstrate that OT intervention improves HRQOL and ADLs in patients with CVD in this study. Nevertheless, this review identified multiple constraints that obscure the effectiveness of OT interventions in CVD.
Issues in OT Research for Patients With CVDWe hypothesized that some common factors contribute to the lack of efficacy of OT interventions for CVD regarding HRQOL and ADLs, fatigue, occupational performance, cardiovascular (cardiac-related) mortality and cardiac-related rehospitalization.
The reason for the small number of eligible papers in this review may be that OT interventions differ from resistance training and aerobic exercise, which are performed in CR, and the intervention methods are difficult to standardize. The load, duration, and frequency of exercise prescription as resistance training and aerobic exercise can be easily set as a numerical value, whereas OT interventions are complex and dynamic processes that require simultaneous consideration of the client, environment, and occupation.33 These elements are difficult to standardize using numerical values, in contrast to aerobic exercise and resistance training; therefore, standardized intervention methods are limited.
In addition, the lack of clarity about the effectiveness of OT in patients with CVD can be attributed to the small number of studies investigating the clinical question. The primary constraints when including a small number of studies are the study design and intervention. After initial screening, 39 (33.8%) studies were not randomized, and 23 (30.2%) studies were not OT studies; 3 studies had no relevant outcome and were excluded from the analysis.
Future StudiesRCT design studies with more specific OT intervention methods, focused on specific participants, are needed to examine the effectiveness of OT in CVD. The major reason why this study did not demonstrate that OT intervention improves HRQOL and ADLs, fatigue, occupational performance, cardiovascular (cardiac-related) mortality and cardiac-related rehospitalization in patients with CVD can be attributed to the lack of studies comparing OT intervention alone with no OT intervention. CR is a multidisciplinary approach,12 and comparing a different approach from traditional CR is necessary to demonstrate the effect of OT. This study included occupational therapists as interventionists at the stage of selecting the inclusion criteria. However, all the retrieved studies included occupational therapists as members of the CR team. Therefore, data showing the improvement in HRQOL and ADLs, fatigue, occupational performance, cardiovascular (cardiac-related) mortality, and cardiac-related rehospitalization due to the intervention of occupational therapists could not be found.
We believe that Abizanda et al.’s study27 may guide the provision of a specific OT protocol. The OT protocol of this study constituted physical, cognitive, social, and emotional assessments, needs analysis, and instructions in patient mobilization techniques for patients and their primary caregivers. OT provided cognitive stimulation, confusional syndrome prevention, and instructions for the family or caregivers on how to retrain ADLs. The group receiving OT reported a increase in cost-effectiveness for patients with medical conditions compared with those not receiving OT. However, the OT protocols require improvement in the future because these practices are performed additionally by physical therapy. In addition, included patients in the future should be limited to those with CVD because the patients in the present study had heart and pulmonary disease. Cost-effectiveness is an important factor in assessing the effectiveness of OT, in addition to HRQOL and ADL.
In addition, 3 studies focused on inpatients, 1 was conducted with community-dwelling residents, and all included elderly patients. We believe that there is a need to focus the scope to elderly patients with CVD and to investigate them in both inpatient and outpatient settings.
Study LimitationsWe identified 3 limitations in this study. First, the patient’s disease was broadly defined as CVD. Limited research was conducted on OT for CVD or vascular disease in the preliminary search. Therefore, we defined the patients in this study as having CVD. Few papers indicated that the patients had CVD; therefore, further research on OT for CVD is required in the future.
Second, the OT interventions were not clearly defined. We defined OT intervention as the involvement of OT in the treatment; however, the type of OT intervention is relevant. Clarifying the practical content of OT specialized in CVD is necessary for incorporation into research methods.
The third limitation involves selecting an outcome that can verify the effects of OT. Objective outcomes such as death and readmission in particular are investigated in the medical field. However, patient-reported outcomes such as QOL and well-being may be more appropriate than objective outcomes in OT. Therefore, research using these outcomes should be conducted.
Research into solving this problem is already underway by the first author group (UMIN ID: UMIN000054571). Further study, which considers the 3 limitations identified in this study, is needed and will focus on the effectiveness of OT for patients with heart failure.
We conducted a systematic review to investigate the effects of OT on patients with CVD. The results showed no clear evidence that OT improves HRQOL or ADLs in patients with CVD. Clinical research with high quality designs is needed to demonstrate the benefits of OT for patients with CVD.
During the preparation of this manuscript, the authors used Gemini by Google to proofread the English for vocabulary and grammar. We thank Editage (www.editage.jp) for English language editing.
This study was not funded.
The authors declare that there are no conflicts of interest.
Please find supplementary file(s);
https://doi.org/10.1253/circrep.CR-24-0162
