The effects of strength training and protein intake in patients undergoing dialysis

ISRCTN	ISRCTN72099857
DOI	https://doi.org/10.1186/ISRCTN72099857
Protocol serial number	N/A
Sponsor	University of Copenhagen (Denmark)
Funders	Renal Association (Nyreforeningen) (Denmark), Nutricia (Denmark), Becket Fund (Becket-fonden) (Denmark), Danish Society Nefrologisk (Dansk Nefrologisk Selskab) (Denmark), Hillerød Hospitals Forskningspulje (Denmark), Danske physiotherapy Research Foundation (Danske Fysioterapeuters Forskningsfond) (Denmark), Lundbeck Foundation (Lundbeckfonden) (Denmark), Kaptajnløjtnant Harald Jensen and Wife Fund (Kaptajnløjtnant Harald Jensens og Hustrus fond) (Denmark)

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

Solskrænten 6
Hillerød
3400
Denmark

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes