End Stage Renal DiseaseTHESISNCT01962597
Trial of Hemodialysis Based Exercise for Strength Improvement Study
A study testing aerobic exercise and resistance training in people with End Stage Renal Disease, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention. Brief Summary: Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- aerobic exercise and resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 18 years of age
- On hemodialysis minimum of 3 times per week
- On hemodialysis > 3 consecutive months
Who cannot join
- Inability to provide consent
- Inability to walk 4-metres
- Chest pain with exertion or myocardial infarction in past 6-months
- Pre-dialysis systolic blood pressure > 200 mm Hg or diastolic BP > 100 mm Hg in past 2-weeks
- Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
- Joint replacement or lower extremity fracture in previous 6-months
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- Severe cognitive impairment
- Currently using corticosteroids >5 mg/day
- Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L.
- Attending nephrologist feels exercise is medically contraindicated
- Scheduled living related kidney transplant in next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention.
Brief Summary:
Read more
Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include:
(i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.
- Conditions
- End Stage Renal Disease
- Being tested
- aerobic exercise, resistance training
- Keywords
- hemodialysis, aerobic exercise, resistance training, walking speed, randomized controlled trial
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
resistance trainingOther
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Active comparator | patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis Receives: Other: aerobic exercise |
| resistance training | Active comparator | patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis Receives: Other: resistance training |
| aerobic exercise and resistance training | Experimental | patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week Receives: Other: aerobic exercise; Other: resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in walking speed over 20 weeks
repeated measures analysis
Measured: 10 and 20 weeks
Secondary outcomes (8)
change in short physical performance battery over 20 weeks
repeated measures analysis
Measured: 10 and 20 weeks
change in EuroQOL-5D-5L over 20 weeks
Health-related quality of life. Repeated measures analysis
Measured: 10 and 20 weeks
change in dialysis recovery time over 20 weeks
repeated measures analysis
Measured: 10 and 20 weeks
change in Nottingham extended activities of daily living index over 20 weeks
repeated measures analysis
Measured: 10 and 20 weeks
change in body anthropometry and composition over 20 weeks.
weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle. Repeated measures analysis
Measured: 10 and 20 weeks
change in inflammation measures over 20 weeks
serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis
Measured: 10 and 20 weeks
hospitalization
Measured: continuous over 20 weeks
death
Measured: continuous over 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Brimble, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962597
- Sponsor's protocol ID
- 13-468
- Acronym
- THESIS
- Status last verified
- Apr 2016
- First submitted
- 8 Oct 2013
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01962597
- Acronym / sponsor ID
- THESIS / 13-468
- Conditions
- End Stage Renal Disease
- Keywords
- hemodialysis, aerobic exercise, resistance training, walking speed, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention.
Brief Summary:
Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include:
(i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Active comparator | Other: aerobic exercisepatients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis |
| resistance training | Active comparator | Other: resistance trainingpatients will undergo supervised lower extremity strength training three times per week pre-hemodialysis |
| aerobic exercise and resistance training | Experimental | Other: aerobic exercise, Other: resistance trainingpatients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- On hemodialysis minimum of 3 times per week
- On hemodialysis > 3 consecutive months
Key exclusion criteria (11 listed)
- Inability to provide consent
- Inability to walk 4-metres
- Chest pain with exertion or myocardial infarction in past 6-months
- Pre-dialysis systolic blood pressure > 200 mm Hg or diastolic BP > 100 mm Hg in past 2-weeks
- Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
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 |
|---|---|---|
| aerobic exercise | Other | aerobic exercise, aerobic exercise and resistance training |
| resistance training | Other | aerobic exercise and resistance training, resistance training |
Primary outcome
change in walking speed over 20 weeks
Time frame: 10 and 20 weeks
repeated measures analysis
8 secondary outcomes
change in short physical performance battery over 20 weeks
Time frame: 10 and 20 weeks
change in EuroQOL-5D-5L over 20 weeks
Time frame: 10 and 20 weeks
change in dialysis recovery time over 20 weeks
Time frame: 10 and 20 weeks
change in Nottingham extended activities of daily living index over 20 weeks
Time frame: 10 and 20 weeks
change in body anthropometry and composition over 20 weeks.
Time frame: 10 and 20 weeks
change in inflammation measures over 20 weeks
Time frame: 10 and 20 weeks
hospitalization
Time frame: continuous over 20 weeks
death
Time frame: continuous over 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and resistance training in people with End Stage Renal Disease, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 2016. 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 Canada. 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. 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?
Results are not available in the source record.
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?
change in walking speed over 20 weeks (time frame: 10 and 20 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 19 Apr 2016.