Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial

Gerald Klaassen, Dorien M Zelle, Gerjan J Navis, Desie Dijkema, Frederike J Bemelman, Stephan J L Bakker, Eva Corpeleijn, Gerald Klaassen, Dorien M Zelle, Gerjan J Navis, Desie Dijkema, Frederike J Bemelman, Stephan J L Bakker, Eva Corpeleijn

Abstract

Background: Low physical activity and reduced physical functioning are common after renal transplantation, resulting in a reduced quality of life. Another common post-transplantation complication is poor cardio-metabolic health, which plays a main role in long-term outcomes in renal transplant recipients (RTR). It is increasingly recognized that weight gain in the first year after transplantation, especially an increase in fat mass, is a highly common contributor to cardio-metabolic risk. The aim of this study is to compare the outcomes of usual care to the effects of exercise alone, and exercise combined with dietary counseling, on physical functioning, quality of life and post-transplantation weight gain in RTR.

Methods: The Active Care after Transplantation study is a multicenter randomized controlled trial with three arms in which RTR from 3 Dutch hospitals are randomized within the first year after transplantation to usual care, to exercise intervention (3 months supervised exercise 2 times per week followed by 12 months active follow-up), or to an exercise + diet intervention, consisting of the exercise training with additional dietary counseling (12 sessions over 15 months by a renal dietician). In total, 219 participants (73 per group) will be recruited. The primary outcome is the subdomain physical functioning of quality of life, (SF-36 PF). Secondary outcomes include other evaluations of quality of life (SF-36, KDQOL-SF, EQ-5D), objective measures of physical functioning (aerobic capacity and muscle strength), level of physical activity, gain in adiposity (body fat percentage by bio-electrical impedance assessment, BMI, waist circumference), and cardiometabolic risk factors (blood pressure, lipids, glucose metabolism). Furthermore, data on renal function, medical history, medication, psychological factors (motivation, kinesiophobia, coping style), nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation and cost-effectiveness are collected.

Discussion: Evidence on the effectiveness of an exercise intervention, or an exercise + diet intervention on physical functioning, weight gain and cardiometabolic health in RTR is currently lacking. The outcomes of the present study may help to guide future evidence-based lifestyle care after renal transplantation.

Trial registration: Number: NCT01047410 .

Keywords: Body weight; Cardiovascular; Diet; Exercise; Kidney; Physical activity.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval is obtained from the University Medical Center Medical Ethics committee (NL49084.042.14).

Consent for publication

The authors agree to publication of this article in BMC Nephrology.

Competing interests

The authors declare no conflict of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Changes in body weight and body composition after renal transplantation. (a: BMI, b: body fat percentage, c: fat-free mass, and d: whole body water content) Reprinted from “The role of diet and physical activity in post-transplant weight gain after renal transplantation” by D.M. Zelle, 2013, Clinical Transplantation, 27: E484-E490. Reprinted with permission
Fig. 2
Fig. 2
Flowchart of the ACT trial

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