Home-based exercise and physical activity intervention after kidney transplantation: impact of exercise intensity (PHOENIX-Kidney). Protocol for a multicentre randomized controlled trial
Abstract
ABSTRACT Background Cardiovascular (CV) disease represents a leading cause of death in kidney transplant recipients (KTRs). Poor physical fitness adds to the increased CV risk of KTRs. Exercise-based rehabilitation and physical activity interventions may prove pivotal in both short and long-term outcomes after kidney transplantation. Methods PHOENIX-Kidney is a prospective, multicentre, randomized, controlled, single-blinded trial with parallel groups. A total of 147 adult de novo KTRs from two independent Belgian transplant centres will be randomized to one of three groups with different exercise intensity: (i) 6 months moderate-intensity aerobic and muscle strengthening exercise training followed by a physical activity intervention (MIT, n = 49), (ii) 6 months moderate- and high-intensity aerobic exercise training and moderate-intensity muscle strengthening exercise training followed by a physical activity intervention (MHIT, n = 49), or (iii) sham exercise training, not followed by a physical activity intervention (CON, n = 49). The training and physical activity interventions are home-based programmes, which will be initiated at 3 and 9 months after transplantation, respectively. Study participants will be followed up until 2 years after transplantation. The primary hypothesis is that peak oxygen uptake (VO2peak) assessed after the 6-month home-based training programme (the primary outcome) will increase more in MHIT than in CON. Secondary hypotheses are that VO2peak…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 49 participants or records.
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