Chronic Kidney DiseaseNCT02155127
Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study
A study testing walking in people with Chronic Kidney Disease, run by University of Utah at 1 site in United States.
Trial summary
Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million individuals. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients over the age of 60 years
- Diagnosed with moderate to severe CKD (stage 2-4)
- Ambulatory (with or without use of an assistive device such as a cane or walker)
- Living in the community, cognitively able to provide consent and understand directions for the tests
- Cognitive ability to understand and carry out an independent home walking program
- Access and ability to communicate with study staff on a weekly basis and available for follow-up testing.
Who cannot join
- Inability to carry out a program of walking independently at home
- Unavailable for follow-up testing, estimated GFR >60 ml/minx1.73m2 and < 15 ml/minx1.73 m2
- Recent cardiac event (within the past 6 months)
- Uncontrolled hypertension
- Uncontrolled diabetes
- Pulmonary disease that may limit the ability to progress with walking
Show all 9Show fewer
- Progressive neuromuscular disease
- Any orthopedic or neuromuscular condition that may be exacerbated by increased walking activity
- diabetic foot ulcer.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million individuals. Impairments in physical function and mobility limitations have been reported in older Chronic Kidney Disease patients, however the consequences of impaired functioning on participation in daily life and quality of life have not been studied. Early identification and interventions to mitigate deterioration in physical function and mobility should lead to improved health and quality of life outcomes in older patients with Chronic Kidney Disease. Although older individuals with Chronic Kidney Disease have reduced survival expectancy, maintaining physical function and mobility may contribute to longer active life expectancy, and higher quality of life despite their diagnosis.
- Conditions
- Chronic Kidney Disease
- Being tested
- walking
- Keywords
- chronic kidney disease, physical function
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walkingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| walking intervention | Experimental | Subjects are randomized to walking/functional strength program with weekly coaching or usual care. The program is for 12 weeks. The intervention includes 3 lower extremity strengthening exercises, and progressive walking. Receives: Behavioral: walking |
| usual care | No intervention | these subjects receive information on walking program, however do not receive any coaching over 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Painter, University of Utah
- Investigators
- Patricia L Painter, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155127
- Sponsor's protocol ID
- IRB_00064407
- Status last verified
- Nov 2016
- First submitted
- 2 Jun 2014
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study
- ClinicalTrials.gov ID
- NCT02155127
- Acronym / sponsor ID
- IRB_00064407
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Jun 2014 (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.
Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million individuals. Impairments in physical function and mobility limitations have been reported in older Chronic Kidney Disease patients, however the consequences of impaired functioning on participation in daily life and quality of life have not been studied. Early identification and interventions to mitigate deterioration in physical function and mobility should lead to improved health and quality of life outcomes in older patients with Chronic Kidney Disease. Although older individuals with Chronic Kidney Disease have reduced survival expectancy, maintaining physical function and mobility may contribute to longer active life expectancy, and higher quality of life despite their diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| walking intervention | Experimental | Behavioral: walkingSubjects are randomized to walking/functional strength program with weekly coaching or usual care. The program is for 12 weeks. The intervention includes 3 lower extremity strengthening exercises, and progressive walking. |
| usual care | No intervention | –these subjects receive information on walking program, however do not receive any coaching over 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients over the age of 60 years
- Diagnosed with moderate to severe CKD (stage 2-4)
- Ambulatory (with or without use of an assistive device such as a cane or walker)
- Living in the community, cognitively able to provide consent and understand directions for the tests
- Cognitive ability to understand and carry out an independent home walking program
Key exclusion criteria (9 listed)
- Inability to carry out a program of walking independently at home
- Unavailable for follow-up testing, estimated GFR >60 ml/minx1.73m2 and < 15 ml/minx1.73 m2
- Recent cardiac event (within the past 6 months)
- Uncontrolled hypertension
- Uncontrolled diabetes
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 |
|---|---|---|
| walking | Behavioural | walking intervention |
Primary outcome
walking speed
Time frame: baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Patricia L Painter, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking in people with Chronic Kidney Disease, run by University of Utah 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 6 inclusion and 9 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 18 Nov 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
walking speed (time frame: baseline to 3 months). 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 18 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.