Condition category
Urological and Genital Diseases
Date applied
14/04/2011
Date assigned
28/04/2011
Last edited
13/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stig Molsted

ORCID ID

Contact details

Solskrænten 6
Hillerød
3400
Denmark

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

Sponsor information

Organisation

University of Copenhagen (Denmark)

Sponsor details

Faculty of Life Sciences (LIFE)
Bulowsvej 17
Frederiksberg C
1870
Denmark

Sponsor type

University/education

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes