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| Multimorbidity rehabilitation versus disease-specific rehabilitation in people with chronic diseases: a pilot randomized controlled trial |
| Barker K, Holland AE, Lee AL, Haines T, Ritchie K, Boote C, Saliba J, Lowe S, Pazsa F, Thomas L, Turczyniak M, Skinner EH |
| Pilot and Feasibility Studies 2018 Nov 29;4(181):Epub |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Multimorbidity (the co-existence of two or more chronic conditions in an individual) is a growing healthcare burden internationally; however, healthcare and disease management, including rehabilitation, is often delivered in single-disease siloes. The aims of this study were to (1) evaluate the safety and feasibility of multimorbidity rehabilitation compared to a disease-specific rehabilitation program in people with multimorbidity and (2) gather preliminary data regarding clinical outcomes and resource utilization to inform the design of future trials. METHODS: A pilot feasibility randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Seventeen individuals with a chronic disease eligible for disease-specific rehabilitation (pulmonary, cardiac, heart failure rehabilitation) and at least one other chronic condition were recruited. The intervention group attended multimorbidity exercise rehabilitation and the control group attended disease-specific exercise rehabilitation. Participants attended twice-weekly exercise training and weekly education for 8 weeks. Feasibility measures included numbers screened, recruited, and completed. Other outcome measures were change in functional exercise capacity (6-minute walk test (6MWT)), health-related quality of life (HRQoL), activities of daily living (ADL), and resource utilization. RESULTS: Sixty-one people were screened to recruit seventeen participants (nine intervention, eight control); one withdrew prior to rehabilitation. Participants were mostly male (63%) with a mean (SD) age of 69 (9) years and body mass index of 29 (6). The intervention group attended a mean (SD) of 12 (6) sessions, and the control group attended 11 (4) sessions. One participant (6%) withdrew after commencing; two (12%) were lost to follow-up. The intervention group 6MWT distance increased by mean (SD) of 22 (45) meters (95% confidence interval 16 to 60) compared to 22 (57) meters (95% confidence interval 69 to 114) (control). CONCLUSIONS: It was feasible to recruit people with multimorbidity to a randomized controlled trial of rehabilitation. A large RCT with the power to make significant conclusions about the impact on the primary and secondary outcomes is now required. TRIAL REGISTRATION: The trial was registered with the Australian and New Zealand Clinical Trials Registry available at http://www.anzctr.org.au ACTRN12614001186640. Registered 12/11/2014.
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