Chronic Kidney DiseasePERFECTNCT01990495
Exercise to Prevent Muscle Mass and Functional Loss in Elderly Dialysis Patients
A study testing Exercise training in people with Chronic Kidney Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The majority of individuals with advanced ESRD have reduced exercise capacity in part due to decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater incidence of falls, and a reduced quality of life. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2013to 30 Sep 2019
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 55-80 years undergoing maintenance hemodialysis (MHD) for at least three months and without other active/uncontrolled disease will be studied.
- Exercise and usual care groups will be matched by age, body mass index (BMI), MHD duration, and protein intake using a stratified randomization approach.
- Subjects will be required to be in the peak VO2 range of 10 to 20 ml/kg/min, equivalent to moderate functional impairment in patients with heart failure.
- Subjects will be required to have dialysis treatment for >3 months with an average Kt/V 1.2, and be able to perform exercise safely.
Who cannot join
- Current activity > 2 hrs/wk of moderate intensity exercise, temporary vascular access, uncontrolled diabetes mellitus, active vasculitis, active autoimmune disease, malignancy, severe obesity (BMI > 35), alcoholism or other recreational drug use, unstable cardiac disease (abnormal exercise test, angina, uncontrolled arrhythmias or myocardial infarction within three months), peripheral vascular disease (claudication with exercise), lung, liver or intestinal disease, those who are medically unstable and subjects who have received anabolic, catabolic or cytotoxic medications in the past 3 months.
- The investigators will also exclude subjects with excessive previous exposure to radiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
The majority of individuals with advanced ESRD have reduced exercise capacity in part due to decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of muscle mass in ESRD are not understood very well. This study is designed to determine the effectiveness of an exercise program on improving muscle mass, exercise capacity and quality of life in persons with ESRD. In addition, the study will attempt to better understand why muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and whether the response to exercise can be enhanced with nutrient supplementation.
Read the detailed description
Elderly patients comprising half the end-stage renal disease (ESRD) population, are especially vulnerable to loss of muscle mass, strength and function, changes that lead to frailty and increased morbidity and mortality. Many factors contribute to the decline in muscle mass and function in the elderly uremic and apart from aging and co-morbid conditions, wasting is worsened by inactivity. Studies in maintenance hemodialysis (MHD) patients have shown that exercise (EX), including endurance, resistance or combined, can counteract the loss of muscle mass and function. However most studies have not specifically targeted the elderly, involved small numbers or lacked controls and the impact on long-term outcome is unknown. Nevertheless, despite substantial evidence indicating that EX is beneficial and low cost, EX is not part of the routine care of MHD patients. In contrast EX is regarded as standard of care for the wasted elderly and also cardiac patients. Some protection against uremic muscle wasting can also be afforded by an adequate protein-calorie intake. Amino acids (AA) from this source serve as substrates for protein synthesis (PS) and also directly activate the mTOR signaling pathway stimulating PS. In normal subjects if AA are ingested at the time of resistance EX, anabolic signaling and PS is enhanced and this leads to increases in muscle mass. Whether the EX and AA stimulated signaling response is intact in elderly MHD patients is unknown and there is little information about the cellular processes invoked. Taking this all together, the investigators plan to test the hypothesis that a home-based EX program, effective in cardiac patients, will improve cardiopulmonary function and muscle mass and function in elderly MHD patients. Also, in a pilot study the investigators will examine whether a protein supplement acutely enhances EX stimulated anabolic signaling. Functionally impaired MHD subjects aged 65-80 yrs are randomized into 2 groups of 30 each, one undergoing EX and the other usual care. After 3 months, half in each group receive a one-time protein-calorie supplement or placebo during an acute bout of EX and muscle biopsied for examining the signaling response. Assays at baseline and at 3 months include cardiopulmonary function, muscle strength and function, body composition by DEXA, thigh muscle volume and composition by CT, quality of life (QOL) and cognitive function, and nutritional, inflammatory, lipid and biochemical status and morphologic and molecular analysis of biopsied muscle. The investigators anticipate that home-based EX will counteract muscle wasting, enhance cardiopulmonary and muscle function and QOL, and reduce surrogate markers of long-term outcome. New insights into the mechanisms whereby EX and nutrients induce an anabolic response in muscle of elderly uremics will be provided and may serve as a basis for devising strategies to counteract loss of muscle mass and function. Finally, the investigators anticipate that the EX program will be "user friendly" and may thus form a part of the routine care of elderly and perhaps younger MHD patients. If short-term benefits are evident from this study in elderly MHD patients, it could form the basis for a comprehensive long-term outcomes study.
- Conditions
- Chronic Kidney Disease
- Being tested
- Exercise training, Usual Care
- Keywords
- Renal failure, Exercise testing, Exercise training, Protein signaling, Skeletal muscle
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Subjects will participate in a center-based and home exercise training program for 3 months.
Usual CareOther
This group will serve as control subjects. They will receive only usual clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Exercise vs. usual care | Active comparator | The study involves two arms randomized to exercise and usual care groups Receives: Other: Exercise training; Other: Usual Care |
| Usual care | Active comparator | This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Uptake
The overall primary outcome for the study is maximal oxygen uptake. Maximal oxygen uptake is the amount of oxygen consumed by the body during maximal exercise. It is the gold standard expression for exercise capacity.
Measured: 3 months
Secondary outcomes (2)
Biopsy of the Quadriceps Muscle.
The biopsy procedures will permit the measurement of the percentage of type 1 fibers in the quadriceps muscle.
The biopsy procedures will also be used to quantify protein signaling, a measure of the capacity of the muscle to gain or lose muscle mass.
Measured: 3 Months
Quality of Life Score
Disease-specific quality of life instrument is used to quantify broad quality of life domains, including physical function.
Higher scores mean better values using a 0-100 scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study start1 Nov 2013
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan Neil Myers, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990495
- Sponsor's protocol ID
- E0915-R
- Acronym
- PERFECT
- Status last verified
- Jan 2021
- First submitted
- 30 Oct 2013
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639Myers J, Chan KN, Chen Y, Lit Y, Massaband P, Kiratli BJ, Tan JC, Rabkin R. Association of physical function and performance with peak VO2 in elderly patients with end stage kidney disease. Aging Clin Exp Res. 2021 Oct;33(10):2797-2806. doi: 10.1007/s40520-021-01801-6. Epub 2021 Mar 8.
PubMed 33686542
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise to Prevent Muscle Mass and Functional Loss in Elderly Dialysis Patients
- ClinicalTrials.gov ID
- NCT01990495
- Acronym / sponsor ID
- PERFECT / E0915-R
- Conditions
- Chronic Kidney Disease
- Keywords
- Renal failure, Exercise testing, Exercise training, Protein signaling, Skeletal muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The majority of individuals with advanced ESRD have reduced exercise capacity in part due to decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of muscle mass in ESRD are not understood very well. This study is designed to determine the effectiveness of an exercise program on improving muscle mass, exercise capacity and quality of life in persons with ESRD. In addition, the study will attempt to better understand why muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and whether the response to exercise can be enhanced with nutrient supplementation.
Detailed description
Elderly patients comprising half the end-stage renal disease (ESRD) population, are especially vulnerable to loss of muscle mass, strength and function, changes that lead to frailty and increased morbidity and mortality. Many factors contribute to the decline in muscle mass and function in the elderly uremic and apart from aging and co-morbid conditions, wasting is worsened by inactivity. Studies in maintenance hemodialysis (MHD) patients have shown that exercise (EX), including endurance, resistance or combined, can counteract the loss of muscle mass and function. However most studies have not specifically targeted the elderly, involved small numbers or lacked controls and the impact on long-term outcome is unknown. Nevertheless, despite substantial evidence indicating that EX is beneficial and low cost, EX is not part of the routine care of MHD patients. In contrast EX is regarded as standard of care for the wasted elderly and also cardiac patients. Some protection against uremic muscle wasting can also be afforded by an adequate protein-calorie intake. Amino acids (AA) from this source serve as substrates for protein synthesis (PS) and also directly activate the mTOR signaling pathway stimulating PS. In normal subjects if AA are ingested at the time of resistance EX, anabolic signaling and PS is enhanced and this leads to increases in muscle mass. Whether the EX and AA stimulated signaling response is intact in elderly MHD patients is unknown and there is little information about the cellular processes invoked. Taking this all together, the investigators plan to test the hypothesis that a home-based EX program, effective in cardiac patients, will improve cardiopulmonary function and muscle mass and function in elderly MHD patients. Also, in a pilot study the investigators will examine whether a protein supplement acutely enhances EX stimulated anabolic signaling. Functionally impaired MHD subjects aged 65-80 yrs are randomized into 2 groups of 30 each, one undergoing EX and the other usual care. After 3 months, half in each group receive a one-time protein-calorie supplement or placebo during an acute bout of EX and muscle biopsied for examining the signaling response. Assays at baseline and at 3 months include cardiopulmonary function, muscle strength and function, body composition by DEXA, thigh muscle volume and composition by CT, quality of life (QOL) and cognitive function, and nutritional, inflammatory, lipid and biochemical status and morphologic and molecular analysis of biopsied muscle. The investigators anticipate that home-based EX will counteract muscle wasting, enhance cardiopulmonary and muscle function and QOL, and reduce surrogate markers of long-term outcome. New insights into the mechanisms whereby EX and nutrients induce an anabolic response in muscle of elderly uremics will be provided and may serve as a basis for devising strategies to counteract loss of muscle mass and function. Finally, the investigators anticipate that the EX program will be "user friendly" and may thus form a part of the routine care of elderly and perhaps younger MHD patients. If short-term benefits are evident from this study in elderly MHD patients, it could form the basis for a comprehensive long-term outcomes study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise vs. usual care | Active comparator | Other: Exercise training, Other: Usual CareThe study involves two arms randomized to exercise and usual care groups |
| Usual care | Active comparator | Other: Usual CareThis group will be randomized to receive usual clinical care. No other interventions will be assigned to this group. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 55-80 years undergoing maintenance hemodialysis (MHD) for at least three months and without other active/uncontrolled disease will be studied.
- Exercise and usual care groups will be matched by age, body mass index (BMI), MHD duration, and protein intake using a stratified randomization approach.
- Subjects will be required to be in the peak VO2 range of 10 to 20 ml/kg/min, equivalent to moderate functional impairment in patients with heart failure.
- Subjects will be required to have dialysis treatment for >3 months with an average Kt/V 1.2, and be able to perform exercise safely.
Key exclusion criteria (2 listed)
- Current activity > 2 hrs/wk of moderate intensity exercise, temporary vascular access, uncontrolled diabetes mellitus, active vasculitis, active autoimmune disease, malignancy, severe obesity (BMI > 35), alcoholism or other recreational drug use, unstable cardiac disease (abnormal exercise test, angina, uncontrolled arrhythmias or myocardial infarction within three months), peripheral vascular disease (claudication with exercise), lung, liver or intestinal disease, those who are medically unstable and subjects who have received anabolic, catabolic or cytotoxic medications in the past 3 months.
- The investigators will also exclude subjects with excessive previous exposure to radiation.
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 |
|---|---|---|
| Exercise trainingSubjects will participate in a center-based and home exercise training program for 3 months. | Other | Exercise vs. usual care |
| Usual CareThis group will serve as control subjects. They will receive only usual clinical care. | Other | Exercise vs. usual care, Usual care |
Primary outcome
Maximal Oxygen Uptake
Time frame: 3 months
The overall primary outcome for the study is maximal oxygen uptake. Maximal oxygen uptake is the amount of oxygen consumed by the body during maximal exercise. It is the gold standard expression for exercise capacity.
2 secondary outcomes
Biopsy of the Quadriceps Muscle.
Time frame: 3 Months
Quality of Life Score
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Derived from this study: PubMed 33686542Myers J, Chan KN, Chen Y, Lit Y, Massaband P, Kiratli BJ, Tan JC, Rabkin R. Association of physical function and performance with peak VO2 in elderly patients with end stage kidney disease. Aging Clin Exp Res. 2021 Oct;33(10):2797-2806. doi: 10.1007/s40520-021-01801-6. Epub 2021 Mar 8.
- 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.
Jonathan Neil Myers, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Chronic Kidney Disease, run by VA Office of Research and Development 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 4 inclusion and 2 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 25 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2021). 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?
Maximal Oxygen Uptake (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990495, which also lists 2 linked publications.
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 25 Jan 2021.