Chronic Kidney DiseasePRTNCT01007838
Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients
A study testing Progressive resistance training programme and Progressive resistance training in people with Chronic Kidney Disease, run by Bangor University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Progressive resistance training programme and Progressive resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney diseases stage five requiring maintenance hemodialysis.
Who cannot join
- Patients who have been receiving dialysis for less than 3 months;
- Are under the age of 18years;
- Have medical contradictions to participate in the exercise programs;
- Any uncontrolled medical condition which does not allow participation in exercise;
- Have known neuro-muscular disorders;
- Have any other uncontrolled medical condition, including pregnancy;
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- Are not independently ambulant for 50 m;
- Have received anabolic intervention, or had catabolic conditions within the last 3 months;
- Have a cardiac pacemaker or other unsuitable implanted device for magnetic resonance;
- Are vulnerable to heat stress;
- Or are unable to give consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust
Bangor, Gwynedd, LL57 2PW
About this study
Official title: Effects of Progressive Resistance Training During Haemodialysis on Muscle Quantity and Function in Patients With Chronic Kidney Disease
The purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis.
It is hypothesised, based on previous literature involving similar resistance training protocols in other catabolic conditions, that the resistance training will result in a significant increase in muscle quantity as well a physical function.
Read the detailed description
Muscle wasting is common in patients with chronic kidney disease and has been associated with decreased ability to complete activities of daily living, increased hospitalisation and therefore and decreased quality of life.
In other catabolic conditions, such as cancer or rheumatoid arthritis, exercise is an established treatment to reverse muscle wasting. It is uncertain whether exercise has this effect in the chronic kidney disease population due to an altered hormone system that may prevent the anabolic effects of exercise from occurring. However, progressive resistance training, which is exercise that is most effective at eliciting an anabolic response has not been effectively carried out with haemodialysis patients.
Therefore, this study aims to investigate whether or not a twelve week intradialytic progressive resistance training programme will have an effect on muscle quantity, physical function and quality of life in patients receiving maintenance haemodialysis.
- Conditions
- Chronic Kidney Disease
- Being tested
- Progressive resistance training programme, Sham exercise, Progressive resistance training
- Keywords
- Progressive Resistance Training/Exercise, Muscle wasting, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance training programmeOther
Also called Intradialytic resistance exercise
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Sham exerciseOther
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Progressive resistance trainingOther
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Sham exerciseOther
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease progressive resistance training group | Experimental | Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure. Receives: Other: Progressive resistance training programme |
| Chronic kidney disease sham exercise group | Sham comparator | Lower body stretching exercise using the easiest rehabilitation elastic Theraband Receives: Other: Sham exercise |
| Healthy controls progressive resistance training group | Experimental | Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure. Receives: Other: Progressive resistance training |
| Healthy controls sham exercise group | Sham comparator | Lower body stretching exercise using the easiest rehabilitation elastic Theraband Receives: Other: Sham exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Cross Sectional Area
Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.
Measured: Change from baseline in cross sectional area at 12 weeks
Secondary outcomes (1)
Muscle Strength
Bilateral knee extensor isometric strength.
Measured: Change from baseline in muscle strength at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Collaborators
- Betsi Cadwaladr University Health Board
- Responsible party
- Sponsor
- Investigators
- Jamie H MacDonald, PhD, Principal investigator, Bangor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007838
- Sponsor's protocol ID
- R& D Ref no: MACDONALD 07/53
- Acronym
- PRT
- Status last verified
- Dec 2011
- First submitted
- 15 Oct 2009
- Last updated
- 5 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Resistance Training During Haemodialysis on Muscle Quantity and Function in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01007838
- Acronym / sponsor ID
- PRT / R& D Ref no: MACDONALD 07/53
- Conditions
- Chronic Kidney Disease
- Keywords
- Progressive Resistance Training/Exercise, Muscle wasting, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Collaborators
- Betsi Cadwaladr University Health Board
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Posted 23 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis.
It is hypothesised, based on previous literature involving similar resistance training protocols in other catabolic conditions, that the resistance training will result in a significant increase in muscle quantity as well a physical function.
Detailed description
Muscle wasting is common in patients with chronic kidney disease and has been associated with decreased ability to complete activities of daily living, increased hospitalisation and therefore and decreased quality of life.
In other catabolic conditions, such as cancer or rheumatoid arthritis, exercise is an established treatment to reverse muscle wasting. It is uncertain whether exercise has this effect in the chronic kidney disease population due to an altered hormone system that may prevent the anabolic effects of exercise from occurring. However, progressive resistance training, which is exercise that is most effective at eliciting an anabolic response has not been effectively carried out with haemodialysis patients.
Therefore, this study aims to investigate whether or not a twelve week intradialytic progressive resistance training programme will have an effect on muscle quantity, physical function and quality of life in patients receiving maintenance haemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease progressive resistance training group | Experimental | Other: Progressive resistance training programmeProgressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure. |
| Chronic kidney disease sham exercise group | Sham comparator | Other: Sham exerciseLower body stretching exercise using the easiest rehabilitation elastic Theraband |
| Healthy controls progressive resistance training group | Experimental | Other: Progressive resistance trainingProgressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure. |
| Healthy controls sham exercise group | Sham comparator | Other: Sham exerciseLower body stretching exercise using the easiest rehabilitation elastic Theraband |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic kidney diseases stage five requiring maintenance hemodialysis.
Key exclusion criteria (11 listed)
- Patients who have been receiving dialysis for less than 3 months;
- Are under the age of 18years;
- Have medical contradictions to participate in the exercise programs;
- Any uncontrolled medical condition which does not allow participation in exercise;
- Have known neuro-muscular disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance training programmeAlso: Intradialytic resistance exerciseProgressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure. | Other | Chronic kidney disease progressive resistance training group |
| Sham exerciseLower body stretching exercise using the easiest rehabilitation elastic Theraband | Other | Chronic kidney disease sham exercise group |
| Progressive resistance trainingProgressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure. | Other | Healthy controls progressive resistance training group |
| Sham exerciseLower body stretching exercise using the easiest rehabilitation elastic Theraband | Other | Healthy controls sham exercise group |
Primary outcome
Muscle Cross Sectional Area
Time frame: Change from baseline in cross sectional area at 12 weeks
Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.
1 secondary outcome
Muscle Strength
Time frame: Change from baseline in muscle strength at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie H MacDonald, PhD principal investigator
Bangor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training programme and Progressive resistance training in people with Chronic Kidney Disease, run by Bangor University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Cross Sectional Area (time frame: Change from baseline in cross sectional area at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.