ACtive Care After Transplantation, the ACT Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Patient and graft survival in the first year after renal transplantation have improved substantially over the last decade, but long-term graft loss and patient mortality have remained high. It is increasingly recognized that the alarmingly poor cardio-metabolic risk profile in renal transplant recipients (RTR) plays a main role in long-term outcome. Improvement of long-term outcome will require specific efforts to improve cardio-metabolic profile and its complications. Importantly, the substantial increase in body weight and body fat that occurs after transplantation is a major trigger for the poor cardiometabolic profile in the RTR, including post-transplant diabetes and metabolic syndrome. The increase in body weight is mostly fat tissue and typically around 9-10 kg. Most of this weight gain ( 90%) occurs in the first year after transplantation. Recent data indicate that steroid avoidance could not prevent this early increase in adiposity. This warrants specific focus on lifestyle factors, i.e diet and physical activity. In the UMCG RTR cohort we found that a lack of physical activity was related to a worse cardiometabolic profile and was an independent predictor of mortality. Moreover, the substantial increase in fat massweight gain was strongly related to low physical activity, high intake of energy-dense drinks, low consumption of vegetables, to increased plasma triglycerides and the metabolic syndrome. The intake of salt and saturated fat was high and fibre intake was low, indicating dietary habits that deviate substantially from recommendations for a healthy diet. Thus, both physical activity and dietary habits are important targets for lifestyle intervention in RTR. Lasting improvements in lifestyle are notoriously difficult to obtain, but in recent years substantial intervention expertise has been developed in other high risk groups including prediabetes. It is now established that for long term purposes, prevention of excessive weight gain is more effective than treatment of weight excess. Since in RTR most of the weight is gained in the first year after transplantation, prevention is a very promising approach. Moreover, data in prediabetes suggest that combined intervention targeting both diet and physical activity may be particularly effective to this purpose. Therefore, our aim is to investigate the effects on quality of life by a combined diet-and-physical activity program in RTR in the first year after transplantation. This randomized controlled intervention study will use a combined diet-and-physical activity approach. After hospital discharge for transplantation, 219 patients will be randomized to three either a control groups: one group, who will receive standard care, one group will be exposed to a 3-month exercise program followed by individual counselling and one group will be exposed to the exercise program + dietary or to intervention followed by individual counselling. The individual counselling is to consolidate the achieved improvements in diet and physical activity and will be provided until 15 months after inclusion. This counselling is based on theories of behavioural change and motivational interviewing. Daily physical activity is evaluated with a pedometer and dietary habits by questionnaires and food records.

Official Title
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ACtive Care After Transplantation, a Lifestyle Intervention in Renal Transplant Recipients

Conditions
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Post-transplant Weight Gain, Kidney Transplant, Metabolic Syndrome

Intervention / Treatment
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* Other: Exercise intervention
* Other: Exercise intervention and dietary advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Informed Consent; >1 year after transplantation Medical approvement for participation in the study by the nephrologist. Exclusion Criteria: Psychopathology; Severe cognitive disorders; Negative advice of the nephrologist and/or cardiologist.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3-arm randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Patients assigned to the usual care group receive the standard medical care (usual care) during the 15 months lasting study period. Physical training does not form a part of the usual care of renal transplant and dialysis patients. After randomisation, patients assigned to the usual care group receive the advice to meet the 'Nederlandse Norm Gezond Bewegen (NNGB), i.e. the advice to perform 30 minutes of moderately intense physical activity at at least five but preferably all days of the week. | |
| Experimental: Exercise intervention<br>The exercise intervention in this group is identical to the exercise-only group. 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<br>* 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.<br>|
| Experimental: Exercise intervention and dietary advice<br>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. | Other: Exercise intervention<br>* 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.<br>Other: Exercise intervention and dietary advice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life - Physical Functioning Score | The subdomain 'Physical Functioning' of Quality of Life (SF36 questionnaire) | baseline, 12 weeks, 6 months and 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Scores | Physical and Mental scores of the Quality of Life SF36 questionnaire | baseline, 12 weeks, 6 months and 15 months | 
| Physical functioning | Exercise capacity by VO2max test and/or submax test | baseline, 12 weeks, 6 months and 15 months | 
| Physical functioning | skeletal muscle strength by maximal strenght test | baseline, 12 weeks, 6 months and 15 months | 
| Body composition | waist circumference | baseline, 12 weeks, 6 months and 15 months | 
| Body composition | body fat percentage (bioelectrical impedance) | baseline, 12 weeks, 6 months and 15 months | 
| Body composition | Height and weight to calculate BMI | baseline, 12 weeks, 6 months and 15 months | 
| Cardiometabolic risk factors | Blood pressure | baseline, 12 weeks, 6 months and 15 months | 
| Cardiometabolic risk factors | Lipid profiles (cholesterol) | baseline, 12 weeks, 6 months and 15 months | 
| Cardiometabolic risk factors | Lipid profiles (triglycerides) | baseline, 12 weeks, 6 months and 15 months | 
| Cardiometabolic risk factors | glucose metabolism | baseline, 12 weeks and 15 months | 
| nutrition | dietary intake (food diaries) | baseline, 12 weeks, (6 months for nutrition intervention only) and 15 months | 
| nutrition | nutritional knowledge (questionnaire) | baseline and 15 months | 
| Psychological factors | motivation (questionnaire) | 12 weeks and 15 months | 
| Psychological factors | kinesiophobia (questionnaire) | baseline and 15 months | 
| Psychological factors | coping style (questionnaire) | baseline | 
| Chronic fatigue | CIS-20 questionnaire | baseline, 12 weeks, 6 months and 15 months | 
| Fatigue and work participation | Fatigue and work questionnaire (NFR) | baseline, 12 weeks, 6 months and 15 months | 
| Cost-effectiveness | care consumption and intervention costs | baseline, 12 weeks, 6, 9, 12 and 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical exercise training, quality of life, exercise capacity, skeletal muscle strength, physical activity level, costeffectiveness, renal transplantation, hemodialysis, peritoneal dialysis, diet