Renal Transplant CandidatePARTNCT00857974
Physical Activity Program for Older Renal Transplant Candidates
A study testing Physical Activity in people with Renal Transplant Candidate, run by Wake Forest University at 1 site in United States.
Trial summary
The physical function of older candidates for renal transplantation and their ability to sustain physical activity programs are currently unknown. The primary goal of this study is to determine the feasibility of a physical activity intervention in older dialysis-dependent patients, assessing its effect on maintaining… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Renal Transplant Candidate
- What is being tested?
- Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2009
- 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
- Age ≥ 60 years
- Listed on the renal transplant waiting list (either active or inactive status)
- Able to give consent
- Able to maintain sitting or standing balance and ambulate without assistance from another person
Who cannot join
- MMSE score less than 21
- Unstable coronary artery disease
- Less than three months since the patient had a myocardial infarction
- Congestive heart failure NY class III or IV
- Lower extremity amputation without prosthesis
- Severe and active lower extremity musculoskeletal problem which prevents participation in the intervention
- Individuals who are more active than the intervention and thus would not be likely to benefit
- SPPB score of 12 (the maximum score) at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Impact of a Physical Activity Intervention on Physical Function and Quality of Life in Aging Candidates for Renal Transplantation: The PART Study
The physical function of older candidates for renal transplantation and their ability to sustain physical activity programs are currently unknown. The primary goal of this study is to determine the feasibility of a physical activity intervention in older dialysis-dependent patients, assessing its effect on maintaining transplant candidacy and outcome after transplantation. Clinical practice guidelines do not set an absolute age limit for evaluating potential renal transplant candidates. While cardiovascular risk assessment and malignancy screening are emphasized in the older age group, physical performance and the risk for disability are often overlooked. Although healthy older patients experience increased life expectancy after renal transplantation versus remaining on dialysis, outcomes such as the capacity to live independently and function well have not been studied. Given the poorer baseline health status in aging end-stage renal disease patients, rapid changes in health on dialysis, and the national organ shortage, it is increasingly important to identify factors that predict better outcomes and devise strategies that will maximize the benefit of transplantation in older individuals.
The investigators hypothesize that muscle is the principal organ system underlying impaired physical function among older transplant candidates, and that decreased muscle mass and physical functioning lead to poorer outcomes in older renal transplant candidates. The investigators propose that a simple bedside performance measurement of lower extremity functional limitations, the Short Physical Performance Battery, will be a strong predictor of outcomes in this patient cohort. The investigators also propose that outcomes can be improved with exercise training, potentially leading to longer durations of active transplant candidacy and greater independence after successful transplantation. The Specific Aims of this research are:
- Determine the feasibility of an exercise intervention in dialysis-dependent wait-listed patients age 60 years and over who will be randomized to one of two groups: usual care versus a structured physical activity program.
- Define the natural history of physical function in patients age 60 years and greater who remain on dialysis or undergo renal transplantation attempting to identify a subgroup of older wait listed patients who are at high risk for developing disability.
- Conditions
- Renal Transplant Candidate
- Being tested
- Physical Activity
- Keywords
- Physical Activity, Renal Transplant Candidate, Physical Function, Body Composition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
The intervention is an individualized, structured, moderate intensity home-based physical activity program. During the first 12 weeks the program will focus on lower extremity strengthening, and thereafter incorporate cardiovascular activity. The target duration of activity is 150 minutes per week, i.e., 20-30 min on most days of the week. However, the program is adjusted based on each participant's progression, initial level of physical fitness and will be modified in response to illness, injury, or physical symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | No physical activity intervention will be prescribed for the Usual Care Arm. |
| Physical Activity | Active comparator | Not described Receives: Other: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument.
Measured: One year
Secondary outcomes (9)
Health-related quality-of-life scores
Measured: One year
Self-reported disability scores
Measured: One year
Re-hospitalization
Measured: One year
Inter-current illness including cardiovascular events or falls
Measured: One year
Endurance
Measured: One year
Body composition by both DEXA and thigh CT
Measured: One year
Grip strength
Measured: One year
Leg strength
Measured: One year
ADL disability
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant CandidateStudies 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- The John A. Hartford Foundation, Association of Subspecialty Professors
- Responsible party
- Sponsor
- Investigators
- Stephen Kritchevsky, Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857974
- Sponsor's protocol ID
- IRB00001451
- Acronym
- PART
- Status last verified
- Aug 2018
- First submitted
- 6 Mar 2009
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Physical Activity Intervention on Physical Function and Quality of Life in Aging Candidates for Renal Transplantation: The PART Study
- ClinicalTrials.gov ID
- NCT00857974
- Acronym / sponsor ID
- PART / IRB00001451
- Conditions
- Renal Transplant Candidate
- Keywords
- Physical Activity, Renal Transplant Candidate, Physical Function, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- The John A. Hartford Foundation, Association of Subspecialty Professors
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Mar 2009 (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.
The physical function of older candidates for renal transplantation and their ability to sustain physical activity programs are currently unknown. The primary goal of this study is to determine the feasibility of a physical activity intervention in older dialysis-dependent patients, assessing its effect on maintaining transplant candidacy and outcome after transplantation. Clinical practice guidelines do not set an absolute age limit for evaluating potential renal transplant candidates. While cardiovascular risk assessment and malignancy screening are emphasized in the older age group, physical performance and the risk for disability are often overlooked. Although healthy older patients experience increased life expectancy after renal transplantation versus remaining on dialysis, outcomes such as the capacity to live independently and function well have not been studied. Given the poorer baseline health status in aging end-stage renal disease patients, rapid changes in health on dialysis, and the national organ shortage, it is increasingly important to identify factors that predict better outcomes and devise strategies that will maximize the benefit of transplantation in older individuals.
The investigators hypothesize that muscle is the principal organ system underlying impaired physical function among older transplant candidates, and that decreased muscle mass and physical functioning lead to poorer outcomes in older renal transplant candidates. The investigators propose that a simple bedside performance measurement of lower extremity functional limitations, the Short Physical Performance Battery, will be a strong predictor of outcomes in this patient cohort. The investigators also propose that outcomes can be improved with exercise training, potentially leading to longer durations of active transplant candidacy and greater independence after successful transplantation. The Specific Aims of this research are:
- Determine the feasibility of an exercise intervention in dialysis-dependent wait-listed patients age 60 years and over who will be randomized to one of two groups: usual care versus a structured physical activity program.
- Define the natural history of physical function in patients age 60 years and greater who remain on dialysis or undergo renal transplantation attempting to identify a subgroup of older wait listed patients who are at high risk for developing disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –No physical activity intervention will be prescribed for the Usual Care Arm. |
| Physical Activity | Active comparator | Other: Physical Activity |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 60 years
- Listed on the renal transplant waiting list (either active or inactive status)
- Able to give consent
- Able to maintain sitting or standing balance and ambulate without assistance from another person
Key exclusion criteria (8 listed)
- MMSE score less than 21
- Unstable coronary artery disease
- Less than three months since the patient had a myocardial infarction
- Congestive heart failure NY class III or IV
- Lower extremity amputation without prosthesis
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 |
|---|---|---|
| Physical ActivityThe intervention is an individualized, structured, moderate intensity home-based physical activity program. During the first 12 weeks the program will focus on lower extremity strengthening, and thereafter incorporate cardiovascular activity. The target duration of activity is 150 minutes per week, i.e., 20-30 min on most days of the week. However, the program is adjusted based on each participant's progression, initial level of physical fitness and will be modified in response to illness, injury, or physical symptoms. | Other | Physical Activity |
Primary outcome
The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument.
Time frame: One year
9 secondary outcomes
Health-related quality-of-life scores
Time frame: One year
Self-reported disability scores
Time frame: One year
Re-hospitalization
Time frame: One year
Inter-current illness including cardiovascular events or falls
Time frame: One year
Endurance
Time frame: One year
Body composition by both DEXA and thigh CT
Time frame: One year
Grip strength
Time frame: One year
Leg strength
Time frame: One year
ADL disability
Time frame: One year
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 15 Aug 2018.
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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.
Stephen Kritchevsky, Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Renal Transplant Candidate, run by Wake Forest University 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 8 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 15 Aug 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?
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?
The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument. (time frame: One year). 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 15 Aug 2018; AzTrials last refreshed its copy on 30 Oct 2026.