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Management of the extrahepatic symptoms of chronic hepatitis C: feasibility of a randomized controlled trial of exercise |
McKenna O, Cunningham C, Gissane C, Blake C |
American Journal of Physical Medicine & Rehabilitation 2013 Jun;92(6):504-512 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: The aim of this study was to explore the feasibility and the efficacy of a physiotherapy-led exercise program in changing the health status of a sample of patients with chronic hepatitis C. DESIGN: A single-blind randomized controlled trial was conducted in a sample of patients with iatrogenically acquired hepatitis C in Ireland. Twenty-two participants were recruited and randomly assigned to exercise (n = 10) and control (n = 12) groups. Both groups received a generic exercise advice leaflet, and the exercise group attended 12 exercise sessions for 6 wks. A battery of physical performance measures and patient-reported outcome measures were assessed at baseline and 6 wks, with 1-yr follow-up of the self-reported measures. RESULTS: Significant group by time interactions during the 6-wk period were found for pain (F[1,20] = 5.15, p = 0.034), grip strength (F[1,20] = 5.94, p = 0.024), aerobic capacity (F[1,20] = 5.73, p = 0.024), and depression (F[1,20] = 6.16, p = 0.022), with the exercise group showing greater positive change. The exercise group also had superior gains in the 36-Item Short-Form Health Survey vitality and social function scores (p < 0.05). The short-term gains were not sustained at 1 yr. CONCLUSIONS: This pilot study shows the feasibility of exercise in hepatitis C management, improving physical fitness, psychologic function, and quality-of-life without worsening symptoms in the short term.
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