Chronic Kidney Disease stage3NCT03582982
Flywheel Exercise for CKD
A study testing Eccentric overload exercise in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Among Veterans, the prevalence of chronic kidney disease (CKD) is reported to be as high as 47.3% and a third higher than the general population. Muscle wasting and dysfunction have been identified as primary consequences of CKD. Disease-induced reductions in lean tissue adversely affect muscle fatigability. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- What is being tested?
- Eccentric overload exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2018to 1 Feb 2020
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ambulatory patients (with or without a gait aid)
- CKD stage 3 or 4
- patients receiving care at the DC VAMC Renal Service
- the ability to speak and read English
- orientation to person, place, and time
Who cannot join
- unable to speak English
- acute renal failure
- pregnant
- unable to follow study instructions
- any uncontrolled cardiovascular or musculoskeletal problems that would make participation in this study unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
Jared M Gollie, PhD, 202-745-8000 ext. 55851, Jared.Gollie@va.gov
Brian M Hoover, MS, 202-745-8000 ext. 55826, Brian.Hoover@va.gov
About this study
Official title: Flywheel Resistance Exercise to Improve Skeletal Muscle in Veterans With Chronic Kidney Disease
Among Veterans, the prevalence of chronic kidney disease (CKD) is reported to be as high as 47.3% and a third higher than the general population. Muscle wasting and dysfunction have been identified as primary consequences of CKD. Disease-induced reductions in lean tissue adversely affect muscle fatigability. Consequently, muscle fatigability may serve as a potential limiting factor that contributes to activity limitations. However, there is a lack of evidence informing our understanding of muscle fatigability in patients with CKD. Dialysis treatment is a major factor contributing to the high financial costs of CKD care. Thus, in addition to potential health and quality of life benefits, treatments capable of maintaining kidney function or delaying the onset of dialysis treatment would provide substantial socio-economic benefit. Both lean body mass and muscle fatigability may be improved through strength training. Eccentric-overload (i.e. muscle lengthening) progressive resistance exercise (PRE) has been shown to be safe and effective for a variety of chronic conditions. Eccentric PRE using portable flywheel technology may provide a clinically viable treatment option to combat muscle impairments in CKD given the cost effectiveness and minimal space requirements for this mode of exercise.
The purpose of this study is to assess feasibility of the eccentric-overload PRE regimen for Veterans with CKD stage 3 \& 4 predialysis using a prospective single-arm pre-test post-test intervention design. The primary aim of the project is to determine the effects of eccentric-overload PRE on muscle fatigability in Veterans with CKD Stages 3 \& 4 predialysis. Feasibility of the regimen will be determined by the time needed to complete the 4-exercise regimen and the perceived exertion levels reported by the study participants.
- Being tested
- Eccentric overload exercise
- Keywords
- resistance exercise, muscle fatigue, physical function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric overload exerciseBehavioural
12 weeks of 2x per week of the following eccentric exercises: squat, shoulder press, row, and bicep curl.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric overload exercise | Experimental | Not described Receives: Behavioral: Eccentric overload exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee extensor isokinetic muscle fatigability index at 12 weeks
Knee extensor muscle fatigability will be assessed using a protocol consisting of 30 repetitions or to failure, whichever comes first, at their maximum strength
Measured: Baseline, Week 12
Change in Muscle blood flow at 12 weeks
Blood flow will be assessed using Doppler ultrasound
Measured: Baseline, Week 12
Change in Isokinetic and isometric peak knee extension force at 12 weeks
Unilateral peak knee extension/flexion isokinetic force (at 180º/s and 60º/s) will be obtained across five continuous repetitions using a load cell
Measured: Baseline, Week 6, Week 12
Change in Short Physical Performance Battery at 12 weeks
This composite score is made up of measures of balance, gait speed (15 ft), and timed chair stands (x5).
Measured: Baseline, Week 12
Change in Timed Up-and-Go at 12 weeks
This test will begin the test with the subject fully sitting in a chair with arm rests, with the upright mobility portion of the test focused on an easily visible marked target 3 meters away from the chair
Measured: Baseline, Week 12
Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks
Sonographic estimates of LBM (aggregate muscle thickness, cm) will serve as a proxy measure for muscle tissue composition in this study
Measured: Baseline, Week 6, Week 12
Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks
Sonographic estimates of myosteatosis (grayscale, or GSL, values, 0-255) will serve as a proxy measure for muscle tissue composition in this study
Measured: Baseline, Week 6, Week 12
Secondary outcomes (8)
Change in Grip strength at 12 weeks
This measure will be obtained with a hand grip dynamometer using the mean value of 3 trials under standardized conditions.
Measured: Baseline, Week 12
Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks
mobility questionnaire; range 0-100, with higher values indicating higher confidence
Measured: Baseline, Week 12
Change in Short Form Health Survey (SF-36) Scale at 12 weeks
general physical functioning questionnaire; each of eight sections range 0-100 with higher values indicating less disability. The eight sections include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Measured: Baseline, Week 12
Change in Falls Efficacy Scale (FES) at 12 weeks
fall avoidance behavior questionnaire; range 10-100, with lower values indicating greater efficacy
Measured: Baseline, Week 12
Change in weight at 12 weeks
Weight (in lbs) using bioelectric scale
Measured: Baseline, Week 6, Week 12
Change in height at 12 weeks
Height (in inches) using stadiometer
Measured: Baseline, Week 6, Week 12
Change in body water at 12 weeks
Body water (%) using bioelectric scale
Measured: Baseline, Week 6, Week 12
Change in Blood Pressure at 12 weeks
After sitting quietly for 5 minutes, resting blood pressure will be recorded in triplicate
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start16 May 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael O Harris-Love, DSc, Principal investigator, Washington DC VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582982
- Sponsor's protocol ID
- 01903
- Status last verified
- Nov 2018
- First submitted
- 15 Jun 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flywheel Resistance Exercise to Improve Skeletal Muscle in Veterans With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03582982
- Acronym / sponsor ID
- 01903
- Keywords
- resistance exercise, muscle fatigue, physical function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- 16 May 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 11 Jul 2018 (actual)
- 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.
Among Veterans, the prevalence of chronic kidney disease (CKD) is reported to be as high as 47.3% and a third higher than the general population. Muscle wasting and dysfunction have been identified as primary consequences of CKD. Disease-induced reductions in lean tissue adversely affect muscle fatigability. Consequently, muscle fatigability may serve as a potential limiting factor that contributes to activity limitations. However, there is a lack of evidence informing our understanding of muscle fatigability in patients with CKD. Dialysis treatment is a major factor contributing to the high financial costs of CKD care. Thus, in addition to potential health and quality of life benefits, treatments capable of maintaining kidney function or delaying the onset of dialysis treatment would provide substantial socio-economic benefit. Both lean body mass and muscle fatigability may be improved through strength training. Eccentric-overload (i.e. muscle lengthening) progressive resistance exercise (PRE) has been shown to be safe and effective for a variety of chronic conditions. Eccentric PRE using portable flywheel technology may provide a clinically viable treatment option to combat muscle impairments in CKD given the cost effectiveness and minimal space requirements for this mode of exercise.
The purpose of this study is to assess feasibility of the eccentric-overload PRE regimen for Veterans with CKD stage 3 \& 4 predialysis using a prospective single-arm pre-test post-test intervention design. The primary aim of the project is to determine the effects of eccentric-overload PRE on muscle fatigability in Veterans with CKD Stages 3 \& 4 predialysis. Feasibility of the regimen will be determined by the time needed to complete the 4-exercise regimen and the perceived exertion levels reported by the study participants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eccentric overload exercise | Experimental | Behavioral: Eccentric overload exercise |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ambulatory patients (with or without a gait aid)
- CKD stage 3 or 4
- patients receiving care at the DC VAMC Renal Service
- the ability to speak and read English
- orientation to person, place, and time
Key exclusion criteria (5 listed)
- unable to speak English
- acute renal failure
- pregnant
- unable to follow study instructions
- any uncontrolled cardiovascular or musculoskeletal problems that would make participation in this study unsafe
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 |
|---|---|---|
| Eccentric overload exercise12 weeks of 2x per week of the following eccentric exercises: squat, shoulder press, row, and bicep curl. | Behavioural | Eccentric overload exercise |
Primary outcome
Change in Knee extensor isokinetic muscle fatigability index at 12 weeks
Time frame: Baseline, Week 12
Knee extensor muscle fatigability will be assessed using a protocol consisting of 30 repetitions or to failure, whichever comes first, at their maximum strength
Change in Muscle blood flow at 12 weeks
Time frame: Baseline, Week 12
Blood flow will be assessed using Doppler ultrasound
Change in Isokinetic and isometric peak knee extension force at 12 weeks
Time frame: Baseline, Week 6, Week 12
Unilateral peak knee extension/flexion isokinetic force (at 180º/s and 60º/s) will be obtained across five continuous repetitions using a load cell
Change in Short Physical Performance Battery at 12 weeks
Time frame: Baseline, Week 12
This composite score is made up of measures of balance, gait speed (15 ft), and timed chair stands (x5).
Change in Timed Up-and-Go at 12 weeks
Time frame: Baseline, Week 12
This test will begin the test with the subject fully sitting in a chair with arm rests, with the upright mobility portion of the test focused on an easily visible marked target 3 meters away from the chair
Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks
Time frame: Baseline, Week 6, Week 12
Sonographic estimates of LBM (aggregate muscle thickness, cm) will serve as a proxy measure for muscle tissue composition in this study
Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks
Time frame: Baseline, Week 6, Week 12
Sonographic estimates of myosteatosis (grayscale, or GSL, values, 0-255) will serve as a proxy measure for muscle tissue composition in this study
8 secondary outcomes
Change in Grip strength at 12 weeks
Time frame: Baseline, Week 12
Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks
Time frame: Baseline, Week 12
Change in Short Form Health Survey (SF-36) Scale at 12 weeks
Time frame: Baseline, Week 12
Change in Falls Efficacy Scale (FES) at 12 weeks
Time frame: Baseline, Week 12
Change in weight at 12 weeks
Time frame: Baseline, Week 6, Week 12
Change in height at 12 weeks
Time frame: Baseline, Week 6, Week 12
Change in body water at 12 weeks
Time frame: Baseline, Week 6, Week 12
Change in Blood Pressure at 12 weeks
Time frame: Baseline, Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Michael O Harris-Love, DSc principal investigator
Washington DC VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric overload exercise in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
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 5 inclusion and 5 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 9 Nov 2018. 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 States. 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?
Contact Jared M Gollie, PhD (202-745-8000 ext. 55851, Jared.Gollie@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee extensor isokinetic muscle fatigability index at 12 weeks (time frame: Baseline, Week 12). The study lists 7 primary outcomes in all. 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 9 Nov 2018.