Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effects of 16 weeks high load strength training and protein intake in patients undergoing dialysis: a prospective randomised controlled trial
Acronym
Study hypothesis
Strength training and protein intake increase muscle strength more than strength training alone in patients undergoing dialysis
Ethics approval
Scientific committee, Region Hovedstaden, Denmark approved on 7th April 2009 (Number: H-D-2008-124)
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Uremic myopathy in end-stage renal disease patients undergoing dialysis
Intervention
Exercise and intake of protein or non-protein energy:
Strength training for lower limbs three times per week in 16 weeks (48 sessions). The patients were randomised to exercise and a protein intake after each exercise session or exercise and a isocaloric non-protein intake.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Muscle strength (equipment: Good Strength)
2. Muscle power (equipment: Power Rig)
3. Physical function (Chair stand test from The Senior Fitness Test)
4. Selfrated health (Short Form 36 questionaire)
5. Muscle size and type (muscle biopsy from the vastus lateralis muscle)
6. Electromyography (EMG) (surface from the vastus lateralis muscle)
7. Anabolic hormones (blood tests)
8. Insulin resistance (the oral glucose tolerence test)
All tests are done three times: A pretest 16 weeks before the baseline test with no intervention in between and a final retest after the 16 weeks of intervention
Secondary outcome measures
1. Physical activity
2. Food intake
3. Body weight
4. Kidney function
All tests are done three times: A pretest 16 weeks before the baseline test with no intervention in between and a final retest after the 16 weeks of intervention
Overall trial start date
15/04/2009
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age above 18 years
2. Dialysis more than three months
3. Able to do strength training
4. Able to talk and read Danish
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
42
Participant exclusion criteria
1. Blindness
2. Lower limb amputation
3. Diabetic retinopathy
4. Anticoagulation treatment by Fondaparinux (Arixtra®)
5. Mental reduction
Recruitment start date
15/04/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Denmark
Trial participating centre
Solskrænten 6
Hillerød
3400
Denmark
Funders
Funder type
Other
Funder name
Renal Association (Nyreforeningen) (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nutricia (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Becket Fund (Becket-fonden) (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Danish Society Nefrologisk (Dansk Nefrologisk Selskab) (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Hillerød Hospitals Forskningspulje (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Danske physiotherapy Research Foundation (Danske Fysioterapeuters Forskningsfond) (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lundbeck Foundation (Lundbeckfonden) (Denmark)
Alternative name(s)
Lundbeck Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Denmark
Funder name
Kaptajnløjtnant Harald Jensen and Wife Fund (Kaptajnløjtnant Harald Jensens og Hustrus fond) (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22959782
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24804194
Publication citations
-
Results
Molsted S, Harrison AP, Eidemak I, Andersen JL, The effects of high-load strength training with protein- or nonprotein-containing nutritional supplementation in patients undergoing dialysis., J Ren Nutr, 2013, 23, 2, 132-140, doi: 10.1053/j.jrn.2012.06.007.
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Results
Molsted S, Andersen JL, Eidemak I, Harrison AP, Jørgensen N, Resistance training and testosterone levels in male patients with chronic kidney disease undergoing dialysis, Biomed Res Int, 2014, doi: 10.1155/2014/121273.