ACtive Care After Transplantation, the ACT Study

Summary

The aim of the present study is to compare the outcomes of standard care to the effects of exercise alone, and exercise combined with nutrition counseling, on post-transplantation weight gain and quality of life in renal transplant recipients (RTR). The primary outcome is subdomain physical functioning of quality of life, (SF-36 PFS).

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). Additionally it is planned to study 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.

Conditions

• Post-transplant Weight Gain
• Kidney Transplant
• Metabolic Syndrome

Interventions

OTHER

Exercise intervention

Patients assigned to the exercise intervention participate in a 12 weeks lasting, intensive, standardized and supervised physical training program which consists of a combination of endurance and strength training. After completion of the training program, patients receive an individual sport- and physical activity advice and lifestyle coaching.

OTHER

Exercise intervention and dietary advice

The exercise intervention in this group is identical to the exercise-only group. The nutritional intervention runs throughout the entire 15 month intervention. The nutritional intervention aims to critically discuss pre-transplantation nutritional habits, and to set goals for healthier, better quality nutrition to prevent over eating and weight gain. These goals are set together with the subject to facilitate an autonomy supportive coaching climate.During the dietary consults, special attention goes out to saturated fat intake, whole-wheat and high fibre foods, fruit and vegetable intake, dietary salt consumption, and the use of energy-rich beverages such as soda, dairy drinks and fruit juices.

Sponsors & Collaborators

• Dutch Kidney Foundation

  collaborator OTHER

• Innovation Fund of the Dutch Medical Insurance Companies

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Eva Corpleleijn, dr · UMCG

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2017-08-01

Completion

2017-11-01

Countries

• Netherlands

Study Locations