ACtive Care After Transplantation (ACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University Medical Center Groningen
Sponsor:
Collaborators:
Dutch Kidney Foundation
Innovation Fund of the Dutch Medical Insurance Companies
Information provided by (Responsible Party):
Dorien Zelle, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01047410
First received: January 11, 2010
Last updated: June 15, 2015
Last verified: June 2015
  Purpose

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 outcomes are post-transplantation weight gain and cardiometabolic risk, and quality of life regarding physical functioning.

Our secondary outcomes are barriers and success factors regarding lifestyle intervention in RTR, the barriers and success factors for intervention for healthcare professionals, and long-term adherence to physical activity during the follow-up phase.


Condition Intervention
Post-transplant Weight Gain
Other: Exercise intervention
Other: Exercise intervention and dietary advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ACtive Care After Transplantation

Resource links provided by NLM:


Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • Quality of life [ Time Frame: baseline, 12 weeks, 6 months and 15 months ] [ Designated as safety issue: No ]
  • Exercise capacity, skeletal muscle strength and physical activity level [ Time Frame: baseline, 12 weeks, 6 months and 15 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 12 weeks and 15 months ] [ Designated as safety issue: No ]
  • Body composition and weight [ Time Frame: baseline, 12 weeks, 6 months and 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nutritional state [ Time Frame: 12 weeks, 6 months and 15 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 12 weeks, 6 months and 15 months ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 12 weeks, 6 months and 15 months ] [ Designated as safety issue: No ]
  • Labour participation [ Time Frame: 12 weeks, 6 months and 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 219
Study Start Date: October 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.
No Intervention: Usual care
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 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.
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.

Detailed Description:

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 fFor 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 prevent the development of adiposity and its adverse cardiometabolic effects 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 3-month exercise protocolprogram intervention group will enrol be adopted from the "Group rehabilitation for renal patients" project of Maastricht. in a fitness program (2 times per week, first three months) and receive.The individual counselling is to consolidate achieved promote a healthy diets and levels of physical activity and will be provided erformed until( 15 months after inclusion throughout the whole year). 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. As outcome parameters, the iIncrease in adiposity and changes in renal function, glucose metabolism and cardio-metabolic risk factors will be assessed at baseline, and at and 3 and 15 and 12 months after inclusion.

As additional benefit, this intervention may improve quality of life and social participation, which will be assessed as well. Furthermore, barriers to intervention success, such as a lack of reference knowledge on healthy nutrition and fear to exercise are identified to optimize the efficacy of the current intervention and facilitate future implementation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047410

Contacts
Contact: Dorien Zelle, Dr. +31-503610885 d.m.zelle@umcg.nl
Contact: Eva Corpleleijn, Dr. +31-5010889 e.corpeleijn@umcg.nl

Locations
Netherlands
Reade Active, not recruiting
Amsterdam, Noord-Holland, Netherlands, 1056 AB
Revalidatiecentrum Lindenhof Completed
Goes, Zeeland, Netherlands, 4462 RA
AMC Recruiting
Amsterdam, Netherlands
Contact: F Bemelman, Dr, MD         
Isala Kliniek Active, not recruiting
Zwolle, Netherlands
Vogellanden Active, not recruiting
Zwolle, Netherlands
Sponsors and Collaborators
Dorien Zelle
Dutch Kidney Foundation
Innovation Fund of the Dutch Medical Insurance Companies
Investigators
Principal Investigator: Eva Corpleleijn, dr UMCG
  More Information

Publications:
van den Ham EC. Body composition and exercise intolerance in renal transplant patients: the response to exercise training. Thesis. 2006.

Responsible Party: Dorien Zelle, Dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01047410     History of Changes
Other Study ID Numbers: METc 2014/190
Study First Received: January 11, 2010
Last Updated: June 15, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Center Groningen:
physical exercise training
quality of life
exercise capacity
skeletal muscle strength
physical activity level
costeffectiveness
renal transplantation
hemodialysis
peritoneal dialysis
diet

Additional relevant MeSH terms:
Weight Gain
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 31, 2015