Post-transplant Weight GainACTNCT01047410
ACtive Care After Transplantation, the ACT Study
A study testing Exercise intervention and Exercise intervention and dietary advice in people with Post-transplant Weight Gain and Kidney Transplant, run by University Medical Center Groningen at 5 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-transplant Weight Gain, Kidney Transplant, Metabolic Syndrome
- What is being tested?
- Exercise intervention and Exercise intervention and dietary advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 5 sitesNetherlands
- Study dates
- Oct 2010to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Informed Consent;
- >1 year after transplantation
- Medical approvement for participation in the study by the nephrologist.
Who cannot join
- Psychopathology;
- Severe cognitive disorders;
- Negative advice of the nephrologist and/or cardiologist.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Reade
Amsterdam, North Holland, 1056 AB
AMC
Amsterdam
Revalidatiecentrum Lindenhof
Goes, Zeeland, 4462 RA
Isala Kliniek
Zwolle
Vogellanden
Zwolle
About this study
Official title: ACtive Care After Transplantation, a Lifestyle Intervention in Renal Transplant Recipients
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.
Read the 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 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.
- Being tested
- Exercise intervention, Exercise intervention and dietary advice
- Keywords
- physical exercise training, quality of life, exercise capacity, skeletal muscle strength, physical activity level, costeffectiveness, renal transplantation, hemodialysis, peritoneal dialysis, diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionOther
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.
Exercise intervention and dietary adviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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. |
| Exercise intervention | Experimental | 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. Receives: Other: Exercise intervention |
| Exercise intervention and dietary advice | Experimental | 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. Receives: Other: Exercise intervention; Other: Exercise intervention and dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life - Physical Functioning Score
The subdomain 'Physical Functioning' of Quality of Life (SF36 questionnaire)
Measured: baseline, 12 weeks, 6 months and 15 months
Secondary outcomes (18)
Quality of Life Scores
Physical and Mental scores of the Quality of Life SF36 questionnaire
Measured: baseline, 12 weeks, 6 months and 15 months
Physical functioning
Exercise capacity by VO2max test and/or submax test
Measured: baseline, 12 weeks, 6 months and 15 months
Physical functioning
skeletal muscle strength by maximal strenght test
Measured: baseline, 12 weeks, 6 months and 15 months
Body composition
waist circumference
Measured: baseline, 12 weeks, 6 months and 15 months
Body composition
body fat percentage (bioelectrical impedance)
Measured: baseline, 12 weeks, 6 months and 15 months
Body composition
Height and weight to calculate BMI
Measured: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
Blood pressure
Measured: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
Lipid profiles (cholesterol)
Measured: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
Lipid profiles (triglycerides)
Measured: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
glucose metabolism
Measured: baseline, 12 weeks and 15 months
nutrition
dietary intake (food diaries)
Measured: baseline, 12 weeks, (6 months for nutrition intervention only) and 15 months
nutrition
nutritional knowledge (questionnaire)
Measured: baseline and 15 months
Psychological factors
motivation (questionnaire)
Measured: 12 weeks and 15 months
Psychological factors
kinesiophobia (questionnaire)
Measured: baseline and 15 months
Psychological factors
coping style (questionnaire)
Measured: baseline
Chronic fatigue
CIS-20 questionnaire
Measured: baseline, 12 weeks, 6 months and 15 months
Fatigue and work participation
Fatigue and work questionnaire (NFR)
Measured: baseline, 12 weeks, 6 months and 15 months
Cost-effectiveness
care consumption and intervention costs
Measured: baseline, 12 weeks, 6, 9, 12 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startOct 2010
- Primary completion1 Aug 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Post-transplant Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation, Innovation Fund of the Dutch Medical Insurance Companies
- Responsible party
- Principal investigator, Eva Corpeleijn, University Medical Center Groningen
- Investigators
- Eva Corpleleijn, dr, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047410
- Sponsor's protocol ID
- METc 2014/190
- Acronym
- ACT
- Status last verified
- Aug 2018
- First submitted
- 11 Jan 2010
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van den Ham EC, Kooman JP, Schols AM, Nieman FH, Does JD, Akkermans MA, Janssen PP, Gosker HR, Ward KA, MacDonald JH, Christiaans MH, Leunissen KM, van Hooff JP. The functional, metabolic, and anabolic responses to exercise training in renal transplant and hemodialysis patients. Transplantation. 2007 Apr 27;83(8):1059-68. doi: 10.1097/01.tp.0000259552.55689.fd.
PubMed 17452896van den Ham EC, Kooman JP, Schols AM, Nieman FH, Does JD, Franssen FM, Akkermans MA, Janssen PP, van Hooff JP. Similarities in skeletal muscle strength and exercise capacity between renal transplant and hemodialysis patients. Am J Transplant. 2005 Aug;5(8):1957-65. doi: 10.1111/j.1600-6143.2005.00944.x.
PubMed 15996245van den Ham EC. Body composition and exercise intolerance in renal transplant patients: the response to exercise training. Thesis. 2006.
van den Ham EC, Kooman JP, Christiaans MH, Nieman FH, van Hooff JP. Weight changes after renal transplantation: a comparison between patients on 5-mg maintenance steroid therapy and those on steroid-free immunosuppressive therapy. Transpl Int. 2003 May;16(5):300-6. doi: 10.1007/s00147-002-0502-1. Epub 2003 Feb 20.
PubMed 12759720van den Ham EC, Kooman JP, Christiaans ML, van Hooff JP. The influence of early steroid withdrawal on body composition and bone mineral density in renal transplantation patients. Transpl Int. 2003 Feb;16(2):82-7. doi: 10.1007/s00147-002-0488-8. Epub 2003 Jan 18.
PubMed 12595969van den Ham EC, Kooman JP, Christiaans MH, Leunissen KM, van Hooff JP. Posttransplantation weight gain is predominantly due to an increase in body fat mass. Transplantation. 2000 Jul 15;70(1):241-2. No abstract available.
PubMed 10919614van den Ham EC, Kooman JP, Christiaans MH, van Hooff JP. Relation between steroid dose, body composition and physical activity in renal transplant patients. Transplantation. 2000 Apr 27;69(8):1591-8. doi: 10.1097/00007890-200004270-00013.
PubMed 10836368Zelle DM, Kok T, Dontje ML, Danchell EI, Navis G, van Son WJ, Bakker SJ, Corpeleijn E. The role of diet and physical activity in post-transplant weight gain after renal transplantation. Clin Transplant. 2013 Jul-Aug;27(4):E484-90. doi: 10.1111/ctr.12149. Epub 2013 Jun 13.
PubMed 23758229Zelle DM, Corpeleijn E, Stolk RP, de Greef MH, Gans RO, van der Heide JJ, Navis G, Bakker SJ. Low physical activity and risk of cardiovascular and all-cause mortality in renal transplant recipients. Clin J Am Soc Nephrol. 2011 Apr;6(4):898-905. doi: 10.2215/CJN.03340410. Epub 2011 Mar 3.
PubMed 21372213Kwakernaak AJ, Zelle DM, Bakker SJ, Navis G. Central body fat distribution associates with unfavorable renal hemodynamics independent of body mass index. J Am Soc Nephrol. 2013 May;24(6):987-94. doi: 10.1681/ASN.2012050460. Epub 2013 Apr 11.
PubMed 23578944Zelle DM, Corpeleijn E, Deinum J, Stolk RP, Gans RO, Navis G, Bakker SJ. Pancreatic beta-cell dysfunction and risk of new-onset diabetes after kidney transplantation. Diabetes Care. 2013 Jul;36(7):1926-32. doi: 10.2337/dc12-1894. Epub 2013 Feb 1.
PubMed 23378624Corpeleijn E, Bakker SJ, Stolk RP. Obesity and impaired renal function: potential for lifestyle intervention? Eur J Epidemiol. 2009;24(6):275-80. doi: 10.1007/s10654-009-9345-8. Epub 2009 May 7.
PubMed 19455406Mensink M, Corpeleijn E, Feskens EJ, Kruijshoop M, Saris WH, de Bruin TW, Blaak EE. Study on lifestyle-intervention and impaired glucose tolerance Maastricht (SLIM): design and screening results. Diabetes Res Clin Pract. 2003 Jul;61(1):49-58. doi: 10.1016/s0168-8227(03)00067-6.
PubMed 12849923Oterdoom LH, de Vries AP, Gansevoort RT, van Son WJ, van der Heide JJ, Ploeg RJ, de Jong PE, Gans RO, Bakker SJ. Determinants of insulin resistance in renal transplant recipients. Transplantation. 2007 Jan 15;83(1):29-35. doi: 10.1097/01.tp.0000245844.27683.48.
PubMed 17220787de Vries AP, Bakker SJ, van Son WJ, van der Heide JJ, Ploeg RJ, The HT, de Jong PE, Gans RO. Metabolic syndrome is associated with impaired long-term renal allograft function; not all component criteria contribute equally. Am J Transplant. 2004 Oct;4(10):1675-83. doi: 10.1111/j.1600-6143.2004.00558.x.
PubMed 15367224
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACtive Care After Transplantation, a Lifestyle Intervention in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01047410
- Acronym / sponsor ID
- ACT / METc 2014/190
- Keywords
- physical exercise training, quality of life, exercise capacity, skeletal muscle strength, physical activity level, costeffectiveness, renal transplantation, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation, Innovation Fund of the Dutch Medical Insurance Companies
- Study start
- Oct 2010
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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. |
| Exercise intervention | Experimental | Other: Exercise interventionThe 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. |
| Exercise intervention and dietary advice | Experimental | Other: Exercise intervention, Other: Exercise intervention and dietary adviceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Informed Consent;
- >1 year after transplantation
- Medical approvement for participation in the study by the nephrologist.
Key exclusion criteria (3 listed)
- Psychopathology;
- Severe cognitive disorders;
- Negative advice of the nephrologist and/or cardiologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionPatients 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, Exercise intervention and dietary advice |
| Exercise intervention and dietary adviceThe 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 |
Primary outcome
Quality of life - Physical Functioning Score
Time frame: baseline, 12 weeks, 6 months and 15 months
The subdomain 'Physical Functioning' of Quality of Life (SF36 questionnaire)
18 secondary outcomes
Quality of Life Scores
Time frame: baseline, 12 weeks, 6 months and 15 months
Physical functioning
Time frame: baseline, 12 weeks, 6 months and 15 months
Physical functioning
Time frame: baseline, 12 weeks, 6 months and 15 months
Body composition
Time frame: baseline, 12 weeks, 6 months and 15 months
Body composition
Time frame: baseline, 12 weeks, 6 months and 15 months
Body composition
Time frame: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
Time frame: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
Time frame: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
Time frame: baseline, 12 weeks, 6 months and 15 months
Cardiometabolic risk factors
Time frame: baseline, 12 weeks and 15 months
nutrition
Time frame: baseline, 12 weeks, (6 months for nutrition intervention only) and 15 months
nutrition
Time frame: baseline and 15 months
Psychological factors
Time frame: 12 weeks and 15 months
Psychological factors
Time frame: baseline and 15 months
Psychological factors
Time frame: baseline
Chronic fatigue
Time frame: baseline, 12 weeks, 6 months and 15 months
Fatigue and work participation
Time frame: baseline, 12 weeks, 6 months and 15 months
Cost-effectiveness
Time frame: baseline, 12 weeks, 6, 9, 12 and 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Background: PubMed 17452896van den Ham EC, Kooman JP, Schols AM, Nieman FH, Does JD, Akkermans MA, Janssen PP, Gosker HR, Ward KA, MacDonald JH, Christiaans MH, Leunissen KM, van Hooff JP. The functional, metabolic, and anabolic responses to exercise training in renal transplant and hemodialysis patients. Transplantation. 2007 Apr 27;83(8):1059-68. doi: 10.1097/01.tp.0000259552.55689.fd.
- Background: PubMed 15996245van den Ham EC, Kooman JP, Schols AM, Nieman FH, Does JD, Franssen FM, Akkermans MA, Janssen PP, van Hooff JP. Similarities in skeletal muscle strength and exercise capacity between renal transplant and hemodialysis patients. Am J Transplant. 2005 Aug;5(8):1957-65. doi: 10.1111/j.1600-6143.2005.00944.x.
- Backgroundvan den Ham EC. Body composition and exercise intolerance in renal transplant patients: the response to exercise training. Thesis. 2006.
- Background: PubMed 12759720van den Ham EC, Kooman JP, Christiaans MH, Nieman FH, van Hooff JP. Weight changes after renal transplantation: a comparison between patients on 5-mg maintenance steroid therapy and those on steroid-free immunosuppressive therapy. Transpl Int. 2003 May;16(5):300-6. doi: 10.1007/s00147-002-0502-1. Epub 2003 Feb 20.
- Background: PubMed 12595969van den Ham EC, Kooman JP, Christiaans ML, van Hooff JP. The influence of early steroid withdrawal on body composition and bone mineral density in renal transplantation patients. Transpl Int. 2003 Feb;16(2):82-7. doi: 10.1007/s00147-002-0488-8. Epub 2003 Jan 18.
- Background: PubMed 10919614van den Ham EC, Kooman JP, Christiaans MH, Leunissen KM, van Hooff JP. Posttransplantation weight gain is predominantly due to an increase in body fat mass. Transplantation. 2000 Jul 15;70(1):241-2. No abstract available.
- Background: PubMed 10836368van den Ham EC, Kooman JP, Christiaans MH, van Hooff JP. Relation between steroid dose, body composition and physical activity in renal transplant patients. Transplantation. 2000 Apr 27;69(8):1591-8. doi: 10.1097/00007890-200004270-00013.
- Background: PubMed 23758229Zelle DM, Kok T, Dontje ML, Danchell EI, Navis G, van Son WJ, Bakker SJ, Corpeleijn E. The role of diet and physical activity in post-transplant weight gain after renal transplantation. Clin Transplant. 2013 Jul-Aug;27(4):E484-90. doi: 10.1111/ctr.12149. Epub 2013 Jun 13.
- Background: PubMed 21372213Zelle DM, Corpeleijn E, Stolk RP, de Greef MH, Gans RO, van der Heide JJ, Navis G, Bakker SJ. Low physical activity and risk of cardiovascular and all-cause mortality in renal transplant recipients. Clin J Am Soc Nephrol. 2011 Apr;6(4):898-905. doi: 10.2215/CJN.03340410. Epub 2011 Mar 3.
- Background: PubMed 23578944Kwakernaak AJ, Zelle DM, Bakker SJ, Navis G. Central body fat distribution associates with unfavorable renal hemodynamics independent of body mass index. J Am Soc Nephrol. 2013 May;24(6):987-94. doi: 10.1681/ASN.2012050460. Epub 2013 Apr 11.
- Background: PubMed 23378624Zelle DM, Corpeleijn E, Deinum J, Stolk RP, Gans RO, Navis G, Bakker SJ. Pancreatic beta-cell dysfunction and risk of new-onset diabetes after kidney transplantation. Diabetes Care. 2013 Jul;36(7):1926-32. doi: 10.2337/dc12-1894. Epub 2013 Feb 1.
- Background: PubMed 19455406Corpeleijn E, Bakker SJ, Stolk RP. Obesity and impaired renal function: potential for lifestyle intervention? Eur J Epidemiol. 2009;24(6):275-80. doi: 10.1007/s10654-009-9345-8. Epub 2009 May 7.
Related trials for Post-transplant Weight Gain
Recruiting
Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)
Kidney Transplant, Overweight or Obese Adults
RecruitingPhase 2
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
NAFLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Corpleleijn, dr principal investigator
University Medical Center Groningen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention and Exercise intervention and dietary advice in people with Post-transplant Weight Gain and Kidney Transplant, run by University Medical Center Groningen at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life - Physical Functioning Score (time frame: baseline, 12 weeks, 6 months and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047410, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.