Chronic Kidney DiseaseAWARDNCT01462097
Exercise Trial in Chronic Kidney Disease
A study testing Aerobic exercise training and Health Education in people with Chronic Kidney Disease, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Aerobic exercise training and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to 31 Oct 2017
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45)
- Age 60 to 85
- English Speaking
Who cannot join
- Dementia or cognitive impairment
- Renal transplant
- New York Heart Association class 3-4 heart failure
- Severe Chronic Lung Disease
- Unstable angina or coronary revascularization within the last 3 months
- Orthopedic problems that would preclude aerobic exercise training
Show all 10Show fewer
- Known, untreated infection
- Disabling arthritis
- Uncontrolled arrhythmia
- More than 14 alcoholic drinks per week
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center / University of Maryland Medical Center
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
About this study
Official title: Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease
Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.
Read the detailed description
This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age >55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntive performance (including executive functions).
Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.
- Conditions
- Chronic Kidney Disease
- Being tested
- Aerobic exercise training, Health Education
- Keywords
- Chronic kidney disease, Exercise, Aerobic capacity, Learning and memory, Executive function, Endothelial function
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingBehavioural
12 months of aerobic exercise
Health EducationBehavioural
12 months of health education sessions
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | 12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home. Receives: Behavioral: Aerobic exercise training |
| Health Education | Active comparator | 12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Aerobic Capacity
VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Measured: Baseline, 6 months, 12 months
Change in 6 Minute Walk
Distance walked in 6 minutes - greater distance represents higher function
Measured: Baseline, 6 months, 12 months
Secondary outcomes (2)
Change in Physical Function
Timed Up and Go Test
Measured: Baseline, 6 months, 12 months
Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)
Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12).
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startMar 2012
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Stephen Seliger, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462097
- Sponsor's protocol ID
- HP-00045276
- Other IDs
- 1R01DK090401-01A1
- Acronym
- AWARD
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2011
- Last updated
- 25 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Liu CK, Miao S, Giffuni J, Katzel LI, Fielding RA, Seliger SL, Weiner DE. Geriatric Syndromes and Health-Related Quality of Life in Older Adults with Chronic Kidney Disease. Kidney360. 2023 Apr 1;4(4):e457-e465. doi: 10.34067/KID.0000000000000078. Epub 2023 Feb 14.
PubMed 36790849Weiner DE, Liu CK, Miao S, Fielding R, Katzel LI, Giffuni J, Well A, Seliger SL. Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2023 Jan;81(1):59-66. doi: 10.1053/j.ajkd.2022.06.008. Epub 2022 Aug 6.
PubMed 35944747
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01462097
- Acronym / sponsor ID
- AWARD / HP-00045276
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Exercise, Aerobic capacity, Learning and memory, Executive function, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2012
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.
Detailed description
This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age >55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntive performance (including executive functions).
Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exercise training12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home. |
| Health Education | Active comparator | Behavioral: Health Education12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45)
- Age 60 to 85
- English Speaking
Key exclusion criteria (10 listed)
- Dementia or cognitive impairment
- Renal transplant
- New York Heart Association class 3-4 heart failure
- Severe Chronic Lung Disease
- Unstable angina or coronary revascularization within the last 3 months
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 training12 months of aerobic exercise | Behavioural | Aerobic exercise |
| Health Education12 months of health education sessions | Behavioural | Health Education |
Primary outcome
Change in Peak Aerobic Capacity
Time frame: Baseline, 6 months, 12 months
VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Change in 6 Minute Walk
Time frame: Baseline, 6 months, 12 months
Distance walked in 6 minutes - greater distance represents higher function
2 secondary outcomes
Change in Physical Function
Time frame: Baseline, 6 months, 12 months
Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)
Time frame: Baseline, 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36790849Liu CK, Miao S, Giffuni J, Katzel LI, Fielding RA, Seliger SL, Weiner DE. Geriatric Syndromes and Health-Related Quality of Life in Older Adults with Chronic Kidney Disease. Kidney360. 2023 Apr 1;4(4):e457-e465. doi: 10.34067/KID.0000000000000078. Epub 2023 Feb 14.
- Derived from this study: PubMed 35944747Weiner DE, Liu CK, Miao S, Fielding R, Katzel LI, Giffuni J, Well A, Seliger SL. Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2023 Jan;81(1):59-66. doi: 10.1053/j.ajkd.2022.06.008. Epub 2022 Aug 6.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training and Health Education in people with Chronic Kidney Disease, run by University of Maryland, Baltimore at 2 sites 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 3 inclusion and 10 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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2023). 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?
Change in Peak Aerobic Capacity (time frame: Baseline, 6 months, 12 months). The study lists 2 primary outcomes in all. 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 NCT01462097, 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 2023.