Study Protocol: The ACT (Active Care after Transplantation) Trial

Individuals who have undergone renal transplantation often experience low physical activity, reduced physical fitness, and reduced physical functioning. In the early stages of chronic kidney disease, patients have declines in levels of physical activity; at progression to end-stage renal disease (ESRD), physical activity levels have further declined in the majority of patients.

Patients with ESRD exhibit deconditioning and reductions in physical functioning. In addition, low cardiorespiratory fitness and muscle weakness are common following renal transplantation, which may benefit from interventions of exercise and physical activity. However, fear of movement, lack of motivation, and fatigue are often present, creating barriers to exercise in the population of renal transplant recipients.

In renal transplant recipients, the incidence and prevalence of cardiovascular disease is estimated to be four to six times higher than in the general population. Post-transplant weight gain is common in renal transplant recipients, leading to possible development of post-transplant diabetes and metabolic syndrome. Post-transplant body mass index is a known risk factor for graft failure and premature death. Poor diet may be a factor in weight gain after transplant; results of a previous study found that renal transplant recipients gain an average of 5.7 kg of body weight in the first year after the procedure.

Gerald Klaassen, MD, and colleagues have designed the ACT (Active Care after Transplantation) pragmatic randomized controlled trial aimed at evaluating the effects of an exercise intervention, and an exercise plus dietary intervention, on physical functioning and quality of life after renal transplant. The study will also examine measures of physical fitness, level of physical activity, gain in adiposity, renal function, and cardiometabolic profile; success factors of lifestyle change in renal transplant recipients will also be investigated. The study also includes a health economics evaluation. Study protocol was described in BMC Nephrology [doi:10.1186/s12882-017-0709-0].

Participants will include renal transplant recipients in the Netherlands. The trial is registered on clinicaltrials.gov as NCT01047410. The trial has three study arms: (1) usual care; (2) exercise intervention; (3) exercise plus diet intervention. The target population is adult renal transplant recipients recruited during routine post-transplantation care less than one year following transplantation. Inclusion criteria are written informed consent; age >18 years; <1 year after transplantation; and approval for participation based on a general medical evaluation by their nephrologist. Exclusion criteria are multiple organ transplantation; psychopathology or serious cognitive impairment, physical or clinical limitations that make participation impossible; pregnancy; or negative screening verdict from the nephrologist or cardiologist. At 15 months, participants receive 10 Euro for participation in the final follow-up measurement.

Participants will be screened by the nephrologist for eligibility within 7 to 10 days after surgery. Each group will include 73 participants (total: 219). Recruitment will occur in three Dutch hospitals to provide wide geographical coverage (University Medical Center Groningen, north; Amsterdam Medical Center, west; and Maastricht University Medical Center, south).

Exercise training is standardized by providing protocols and the same exercise training protocol for all interventionists. For the dietary intervention, dieticians must meet selection criteria, including experience in counseling renal patients, or other patients with a serious chronic metabolic condition; education and experience in motivational interviewing; and education and experience in Subjective Global Assessment of Malnutrition. Lifestyle coaches are required to have experience in lifestyle counseling for renal patients or other patients with a serious chronic metabolic condition, and education and experience in motivational interviewing.

Participants in the usual care group receive standard post-transplant care. Current nutrition care includes one to four inpatient consultations by a renal dietitian during the inpatient stay, followed by one outpatient consultation. There is no exercise or lifestyle counseling included in standard post-transplant care at any of the participating hospitals.

The exercise intervention includes two phases. The first phase is a 3-month exercise training program; it is followed by a second phase consisting of active follow-up for 12 months with lifestyle counseling. The training program includes two exercise training sessions per week (21 exercise training sessions and 3 test sessions in total). The program focuses on improving maximum muscle strength, local muscle endurance, and aerobic capacity. During the 12-month active follow-up phase, participants will be encouraged to continue sports activities and daily physical activity.

The exercise plus diet intervention arm receives the same exercise training as that in the exercise arm, plus dietary counseling. The counseling continues through the duration of the study period and includes 12 counseling sessions with a renal dietician, Goals are set to improve nutrition status to preserve renal function, and to prevent weight gain, type 2 diabetes, and hypercholesterolemia.

Participants in all three arms receive standard immunosuppression treatment.

The primary outcome of interest is the subdomain physical functioning of quality of life of the Short Form-36. Secondary outcomes include other evaluations of quality of life, muscle strength, aerobic capacity, physical activity, gain in adiposity, and cardiometabolic risk factors. Data on renal function, medical history, medication, psychosocial factors, nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation, and cost-effectiveness will also be collected.

The authors cited the complexity of the study as a possible limitation. Combining the exercise only group with the exercise plus dietary counseling group may lead to contamination between the groups.

“The present study aims to provide evidence needed to guide decision making by clinicians and policy makers in post-transplantation care. Furthermore, it will help develop guidelines for post-transplantation care in the Netherlands to further improve long-term outcomes of renal transplantation,” the researchers said.

TAKEAWAY POINTS

Researchers describe the ACT (Active Care after Transplantation) study to be conducted at three hospitals in the Netherlands.

The study will have three arms; adult renal transplant recipients will be randomized to (1) standard care; (2) exercise intervention; or (3) exercise plus dietary intervention.

The primary outcome of interest is the subdomain physical functioning of quality of life (SF-36 PF). Secondary outcomes include other evaluations of quality of life, objective measures of physical functioning, gain in adiposity, level of physical activity, and cardiometabolic risk factors.