The effects of strength training and protein intake in patients undergoing dialysis
| ISRCTN | ISRCTN72099857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72099857 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/04/2011
- Registration date
- 28/04/2011
- Last edited
- 13/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Stig Molsted
Scientific
Scientific
Solskrænten 6
Hillerød
3400
Denmark
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | The effects of 16 weeks high load strength training and protein intake in patients undergoing dialysis: a prospective randomised controlled trial |
| Study objectives | Strength training and protein intake increase muscle strength more than strength training alone in patients undergoing dialysis |
| Ethics approval(s) | Scientific committee, Region Hovedstaden, Denmark approved on 7th April 2009 (Number: H-D-2008-124) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/04/2009 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 42 |
| Key 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 |
| Key exclusion criteria | 1. Blindness 2. Lower limb amputation 3. Diabetic retinopathy 4. Anticoagulation treatment by Fondaparinux (Arixtra®) 5. Mental reduction |
| Date of first enrolment | 15/04/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Solskrænten 6
Hillerød
3400
Denmark
3400
Denmark
Sponsor information
University of Copenhagen (Denmark)
University/education
University/education
Faculty of Life Sciences (LIFE)
Bulowsvej 17
Frederiksberg C
1870
Denmark
"ROR" |
https://ror.org/035b05819 |
|---|
Funders
Funder type
Other
Renal Association (Nyreforeningen) (Denmark)
No information available
Nutricia (Denmark)
No information available
Becket Fund (Becket-fonden) (Denmark)
No information available
Danish Society Nefrologisk (Dansk Nefrologisk Selskab) (Denmark)
No information available
Hillerød Hospitals Forskningspulje (Denmark)
No information available
Danske physiotherapy Research Foundation (Danske Fysioterapeuters Forskningsfond) (Denmark)
No information available
Lundbeck Foundation (Lundbeckfonden) (Denmark)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Lundbeckfonden
- Location
- Denmark
Kaptajnløjtnant Harald Jensen and Wife Fund (Kaptajnløjtnant Harald Jensens og Hustrus fond) (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No |
