ACtive Care After Transplantation, the ACT Study

Metabolic Syndrome Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047410
• Other study ID #: METc 2014/190
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: November 1, 2017

Study information

• Verified date: August 2018
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: November 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam
Netherlands	Reade	Amsterdam	Noord-Holland
Netherlands	Revalidatiecentrum Lindenhof	Goes	Zeeland
Netherlands	Isala Kliniek	Zwolle
Netherlands	Vogellanden	Zwolle

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Dutch Kidney Foundation, Innovation Fund of the Dutch Medical Insurance Companies

Country where clinical trial is conducted

Netherlands, 

References & Publications (15)

Corpeleijn 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. — View Citation

de 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. — View Citation

Kwakernaak 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. — View Citation

Mensink 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. — View Citation

Oterdoom 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. — View Citation

van 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. — View Citation

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. Epub 2003 Feb 20. — View Citation

van 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. — View Citation

van 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. Epub 2003 Jan 18. — View Citation

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. — View Citation

van 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. — View Citation

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

Zelle DM, Corpeleijn E, Deinum J, Stolk RP, Gans RO, Navis G, Bakker SJ. Pancreatic ß-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. — View Citation

Zelle 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. — View Citation

Zelle 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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