Data on the clinical, functional, and patient-reported outcomes of patient-centred rehabilitation for patients with non-communicable disease living in low-resourced settings

In this data article, we present data obtained from a randomized clinical trial aimed at determining the feasibility of patient-centred rehabilitation for people with non-communicable disease (NCD) living in a low-resource setting. Patients were identified at primary care level and considered eligible if having on or more of the NCDs central to the NCD burden of disease (Cardiovascular Disease, Diabetes, Pulmonary Disease or Cancer). Using a “trial within cohort” design, a total 74 patients were included (36% of those identified as eligible) in a longitudinal cohort with repeated assessments at baseline, 8 and 16 weeks. A subset of 50 participants were randomly selected and offered to participate in a 6-week exercise and education-based, minimalistic, community-based rehabilitation program tailored to the low-resource context. The exercise component included aerobic and resistance exercise, as well as thematic empowerment aimed at improving exercise self-efficacy. The education component was aimed at improving general health literacy. Data was collected in terms of feasibility parameters (e.g., uptake, adherence), patient-demographics (e.g., age, gender), medical demographics (e.g., disease burden, multimorbidity), functional capacity measures (e.g., 6-minute Walk Test), and patient-reported outcomes (e.g., health-related quality of life). The data presented can give a basis for further clinical research in this field.

participate in a 6-week exercise and education-based, minimalistic, community-based rehabilitation program tailored to the low-resource context. The exercise component included aerobic and resistance exercise, as well as thematic empowerment aimed at improving exercise self-efficacy. The education component was aimed at improving general health literacy. Data was collected in terms of feasibility parameters (e.g., uptake, adherence), patient-demographics (e.g., age, gender), medical demographics (e.g., disease burden, multimorbidity), functional capacity measures (e.g., 6-minute Walk Test), and patient-reported outcomes (e.g., healthrelated quality of life). The data presented can give a basis for further clinical research in this field.

Value of the Data
• Data presented in the current paper provide information on a heterogeneous sample of patients with non-communicable disease living in an urban, complex, low-resource setting and can inform future study design and power analyses. These data may be particularly useful for clinical researchers within the rehabilitation space (and beyond) with a focus on resourceconstrained settings [4] , as they provide real-world insight into within-sample variance and participant flow. Future studies could use these data to make informed decisions with respect to study design, in particular the "Trial within cohort" design, the required sample size, and measures to improve participant adherence and retention.

Data Description
The data shared are supplementary tables and figures of analysed data from a randomized clinical trial on the feasibility of a minimalistic patient-centred rehabilitation program for people with non-communicable disease living in a low-resource setting [5] . Patients were recruited from a community-based, public-sector, primary care facility within the Cape Flats region of Cape Town, South Africa. The adapted flowchart, published elsewhere [1] , outlines the flow of participants through the study, adapted for the "trial within cohort" design adopted [1 , 6 , 7] , and in line with CONSORT recommendations [8] . Data on study uptake, exclusion rate, inclusion rate, intervention uptake, retention at follow-up, and adherence to intervention components can be drawn from this flowchart. Table 1 provides baseline characteristics for the study sample, stratified by the three study arms. Table 2 provides baseline values for the clinical markers, functional measures, and patient-reported outcomes, as well as their values post-intervention and during follow-up. Fifteen data files can be found in the repository that underly each of the Group C (Intervention)  tables, including in/exclusion patient characteristics and demographics, medical history, randomisation key, patient-reported outcomes, functional capacity tests, and health economics (patient perspective).

Experimental Design, Materials and Methods
A detailed description of the intervention and outcomes is provided elsewhere [5] . Herein, a short description is provided.

Population
Adult patients with non-communicable disease (i.e., Cancer, Cardiovascular Disease, Chronic Pulmonary Disease and/or Diabetes) were included from a public-sector primary care facility.
Comorbidities were considered unless they were considered a strict safety-risk for participating in exercise therapy, as per the guidelines provided by the American College of Sports Medicine [9] , and outline in the study protocol [5] . Furthermore, patients were excluded if they would jeopardize the safe conduct of study, for example severe psychiatric disease or irrational behaviour related to drug or alcohol abuse.

Intervention
Participants in the intervention group were offered a 6-week patient-centred rehabilitation program comprising of: i) One supervised session a week of individualised aerobic and resistance training presented in a group setting. Each of the 6 exercise sessions had a specific theme (e.g., safety of exercise, what comprises moderate intensity, goal setting) to promote exercise self-efficacy. Individual exercise prescription was based on baseline assessment (e.g., outcome of the 6-minute walk test), and completed by a clinical physiotherapist, experienced in providing group-based interventions in low-resource settings. No specialized equipment was used, rather easily accessible resources (e.g., water bottle),to ensure continuation of the program at home, twice per week. The overarching aim was to equip the participants to be active for 150 min/week at a moderate intensity following completion of the program. ii) Every other week, participants would engage in a one-hour health education session covering the themes of non-communicable diseases related to lifestyle, heart-health behaviour, and the benefits of physical activity. Sessions were facilitated by the physiotherapist.
As programs as short as 3 -5 weeks have shown clinical benefits [5] , in this study, a sixweek program was hypothesised to impact clinical, functional and/or patient-reported outcomes, while minimizing the resources required (provider, and patient).
Session adherence was recorded by the supervising physiotherapist (AR), and home-based exercise was recorded by participants in an exercise diary. All patients received care as usual, including routine follow-up health screening by the primary physician. The control group did not receive structured exercise and education.

Outcome measures
A detailed description of the outcome measures included in the study are provided elsewhere [5] . In the present report, the following sample characteristics and outcome measures are included.
• Patient demographics (sex, age) • Contextual factors (education level, employment, household income, number of adults per household, and number of participants with medical insurance) • Medical demographics (Number of people with cancer, cardiovascular disease, pulmonary disease and/or diabetes, and number of comorbidities) • Risk factors (smoking, alcohol, fruit and vegetable intake, physical activity) • Clinical markers (body mass index, waist-to-hip ratio, waist-to-height ratio, systolic blood pressure, diastolic blood pressure, and resting heart rate) • Functional measures (6-minute walk test, timed up-and-go test, six-spot step test) • Patient-report outcome measures (Pittsburgh Sleep Quality Index, EuroQol 5D measure of Health-Related Quality of Life, and the International Physical Activity Questionnaire) Repeated measures are presented for the clinical, functional, and patient-reported outcomes.

Trial within cohort design, randomization, and masking
A concealed, decentralized, variable block-size randomization (3:1) scheme was used as part of a trial within cohort design meaning that all participants were recruited for a longitudinal cohort with assessments at baseline, 8 weeks, and 16 weeks. Subsequently, 75% of participants were offered to participate in the experimental intervention. Participants could subsequently make an informed decision whether they wanted to participate or not. Reasons for non-participation were noted, and since those participants remained part of the cohort, detailed health outcomes were obtained. Those participants that were not offered the intervention remained in the cohort and received care as usual. All outcomes were assessed blinded to treatment allocation by a trained physiotherapist (BF).

Statistical analyses
Due to the small sample size and lack of a clearly operationalised null hypothesis, no formal statistical analyses were conducted, or p-values provided. Data are presented as mean and 95% confidence intervals. Future studies need to make an informed decision with respect to the type of analysis most appropriate for their respective study, including per-protocol analyses, complier average causal effect analyses, or conventional intention-to-treat analyses. Similarly, an informed decision can be made with respect to participants unwilling to consent to the experimental condition whether to treat those as controls, or as part of the treatment group.

Ethics Statements
This trial was prospectively registered (PACTR201807847711940). Ethical approval was ob-

Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests.

Data Availability
Dataset for the Feasibility of Patient-Centred Rehabilitation in Low-resource Settings (Original data) (Mendeley Data).