ACtive Care After Transplantation, the ACT Study

NCT01047410 | Completed

• 1 other identifier: METc 2014/190
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

physical exercise training; quality of life; exercise capacity; skeletal muscle strength; physical activity level; costeffectiveness; renal transplantation; hemodialysis; peritoneal dialysis; diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Quality of Life Scores

  baseline, 12 weeks, 6 months and 15 months

• Physical functioning

  baseline, 12 weeks, 6 months and 15 months

• Physical functioning

  baseline, 12 weeks, 6 months and 15 months

• Body composition

  baseline, 12 weeks, 6 months and 15 months

• Body composition

  baseline, 12 weeks, 6 months and 15 months

Study Arms (3)

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.

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.

Other: Exercise intervention; Other: Exercise intervention and dietary advice

Interventions

Exercise intervention OTHER

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; Exercise intervention and dietary advice

Exercise intervention and dietary advice OTHER

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.

Exercise intervention and dietary advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Informed Consent;
• \>1 year after transplantation
• Medical approvement for participation in the study by the nephrologist.

You may not qualify if:

• Psychopathology;
• Severe cognitive disorders;
• Negative advice of the nephrologist and/or cardiologist.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Kidney Foundation: collaborator
• Innovation Fund of the Dutch Medical Insurance Companies: collaborator

Study Sites (5)

Reade

Amsterdam, North Holland, 1056 AB, Netherlands

Location

Revalidatiecentrum Lindenhof

Goes, Zeeland, 4462 RA, Netherlands

Location

AMC

Amsterdam, Netherlands

Location

Isala Kliniek

Zwolle, Netherlands

Location

Vogellanden

Zwolle, Netherlands

Location

Related Publications (18)

• 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.

  PMID: 17452896 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2005.00944.x.

  PMID: 15996245 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 12759720 BACKGROUND

• 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. doi: 10.1007/s00147-002-0488-8. Epub 2003 Jan 18.

  PMID: 12595969 BACKGROUND

• 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. No abstract available.

  PMID: 10919614 BACKGROUND

• 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. doi: 10.1097/00007890-200004270-00013.

  PMID: 10836368 BACKGROUND

• 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.

  PMID: 23758229 BACKGROUND

• 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.

  PMID: 21372213 BACKGROUND

• 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.

  PMID: 23578944 BACKGROUND

• Zelle 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.

  PMID: 23378624 BACKGROUND

• 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.

  PMID: 19455406 BACKGROUND

• 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. doi: 10.1016/s0168-8227(03)00067-6.

  PMID: 12849923 BACKGROUND

• 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. doi: 10.1097/01.tp.0000245844.27683.48.

  PMID: 17220787 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2004.00558.x.

  PMID: 15367224 BACKGROUND

• Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

  PMID: 33782940 DERIVED

• Hessels AC, van der Hoeven JH, Sanders JSF, Brouwer E, Rutgers A, Stegeman CA. Leg muscle strength is reduced and is associated with physical quality of life in Antineutrophil cytoplasmic antibody-associated vasculitis. PLoS One. 2019 Feb 4;14(2):e0211895. doi: 10.1371/journal.pone.0211895. eCollection 2019.

  PMID: 30716132 DERIVED

• Klaassen G, Zelle DM, Navis GJ, Dijkema D, Bemelman FJ, Bakker SJL, Corpeleijn E. Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial. BMC Nephrol. 2017 Sep 15;18(1):296. doi: 10.1186/s12882-017-0709-0.

  PMID: 28915863 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Eva Corpleleijn, dr

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes assessors are blinded if possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 3-arm randomized controlled trial

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

NL (5)