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Group Rehabilitation for Renal Patients

This study is currently recruiting participants.
Verified May 2011 by Maastricht University Medical Center
Sponsor:
Collaborators:
Dutch Kidney Foundation
Innovation Fund of the Dutch Medical Insurance Companies
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01047410
First received: January 11, 2010
Last updated: May 12, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of the study is:

  1. to determine the long-term effectiveness of a 12 weeks lasting physical exercise training program.
  2. to determine the cost effectiveness of the 12 weeks lasting physical exercise training program.

Condition Intervention
Renal Insufficiency
 Other: rehabilitation / physical training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Group Rehabilitation for Renal Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

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

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: 320
Study Start Date: October 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation
Patients assigned to the rehabilitation 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. Subsequently, patients will receive usual care in the 12 months lasting follow-up period.
 Other: rehabilitation / physical training
Patients assigned to the rehabilitation 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. Subsequently, patients will receive usual care in the 12 months lasting follow-up period.
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.

Detailed Description:

Exercise intolerance and skeletal muscle weakness are common in dialysis and renal transplant patients and severely compromise quality of life. In an earlier study, the short-term effectiveness of an intensive, supervised exercise training program (twice weekly during a period of 12 weeks; combination of endurance and resistance training) has been investigated in a natural groups cohort study. Exercise training seemed to have beneficial effects on exercise capacity, skeletal muscle strength and quality of life of renal transplant and hemodialysis patients.

The long-term effectiveness and cost-effectiveness of exercise training programs for renal transplant and dialysis patients have, however, not yet been established. Therefore, the long-term effectiveness and cost-effectiveness of an intensive, supervised exercise training program will be investigated in a randomized controlled design in renal transplant and dialysis patients.

Results of such a study are important to convince health care insurers that exercise training is (cost)effective and has to be considered as a structural part of the routine treatment of renal transplant and dialysis patients and therefore should be routinely reimbursed.

  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;

  • For renal transplant patients:

    • stable renal function;
    • transplantation at least 3 months before start of the study;

  • For hemodialysis and peritoneal dialysis patients:

    • at least 3 months dependent on dialysis.

Exclusion Criteria:

  • Psychopathology;
  • Severe cognitive disorders;
  • Negative advice of the nephrologist and/or cardiologist.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047410

Contacts
Contact: Eugenie C.H. van den Ham, Dr. +31-43-3875007 Eugenie.vanden.ham@mumc.nl
Contact: Maarten H.L. Christiaans, Dr. MD +31-43-3875007 M.Christiaans@mumc.nl

Locations
Netherlands
CIRO Horn Not yet recruiting
Horn, Limburg, Netherlands, 6085 NM
Contact: Follows            
Reade Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1056 AB
Contact: Martin Fluit     +31-20-5896503     m.fluit@reade.nl    
Revalidatiecentrum het Roessingh Not yet recruiting
Enschede, Overijssel, Netherlands, 7522 AH
Contact: Bert Jaspers     +31-53-4875875     b.jaspers@roessingh.nl    
Revalidatiecentrum Lindenhof Recruiting
Goes, Zeeland, Netherlands, 4462 RA
Contact: Han Mes     +31-113-236236     h.mes@revant.nl    
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Kidney Foundation
Innovation Fund of the Dutch Medical Insurance Companies
Investigators
Principal Investigator: Maarten H.L. Christiaans, Dr. MD Maastricht University Medical Center
  More Information

Publications:
Gijsen BCM, Veenstra MY. Revalidatieprogramma Herstel en Balans biedt perspectief. Oncologica 2001; 1:29-31.
Gijsen BCM, Lunter S, Postma-Schuit F, Ros W, Tummers R. Rehabilitation in the Netherlands: Herstel & Balans, a promising program for cancer patients. Eur J Cancer 2001; 37 (suppl. 6): 397.
Merkus MP, Krediet RT. Quality of life and functional status in chronic hemo- and peritoneal dialysis. In: Complications of dialysis - Recognition and Management. Lameire NH, Mehta RL (eds). New York, Marcel Dekker Inc 2000:497-515.

Responsible Party: Dr. M. Christiaans, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01047410     History of Changes
Other Study ID Numbers: MEC 09-02-081
Study First Received: January 11, 2010
Last Updated: May 12, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013