Kidney TransplantNCT03535584
Exercise to Treat Frailty and Decreased Physical Function in Transplant Candidates
A study testing Exercise Program in people with Kidney Transplant and Frailty, run by Mayo Clinic at 1 site in United States.
Trial summary
Frailty is a condition characterized by slowness, weakness, low physical activity, wasting, and exhaustion. Frailty increases the risk for adverse outcomes following transplant such as increased length of stay in the hospital, mortality, or graft function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Frailty
- What is being tested?
- Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 26 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Consenting to research
- CKD (stages 1-5)
- An SPPB score ≤10 or considered frail or pre-frail by FP
Who cannot join
- Younger than 18 years
- Patients listed for heart or lung transplants
- Terminal illness with a prognosis of less than 6 months
- Significant comorbidities that limit rehabilitation potential including pulmonary disease requiring continuous oxygen supplementation, active angina, critical aortic sclerosis, decompensated heart failure, or known ventricular arrhythmia.
- Kidney transplant candidates without cardiac clearance for transplant
- An SPPB score >10 or not considered frail or pre-frail by FP
- Non-English speaker without availability of adequate interpreter services (safety concern)
- Failure to pass submaximal exercise test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise as an Intervention to Treat Frailty and Decreased Physical Function in Kidney Transplant Candidates
Frailty is a condition characterized by slowness, weakness, low physical activity, wasting, and exhaustion. Frailty increases the risk for adverse outcomes following transplant such as increased length of stay in the hospital, mortality, or graft function. No interventions for frailty are known for patients with renal disease, but exercise programs like pulmonary rehabilitation have been effective in improving frailty in patients with other diseases, such as lung disease. The goal of this study is to test whether exercise will also improve frailty among patients who are waiting for a kidney transplant and who are considered frail or pre-frail.
Read the detailed description
RECRUITMENT: This study will be conducted at Mayo Clinic in Rochester, MN. Patients over 18 who have chronic kidney disease will be approached for recruitment. Interested patients will go through the informed consent process and, if frailty testing was not completed within the two weeks prior to consent, patients will complete frailty testing. If patients are considered frail or pre-frail, they will be enrolled in the study.
FRAILTY TESTING: Participants will complete the FP, Short Physical Performance Battery (SPPB) and other frailty testing at the beginning of the study, 4 weeks after beginning the intervention, and 8 weeks after beginning the intervention. Frailty testing will include a hand grip strength test, a gait speed test over 15 feet, repeated chair stands, balance testing, and a body composition scan. Participants will also be asked to wear an activity monitor for 5-7 days at each testing point and to complete a set of questionnaires. Height, weight, BMI, skeletal muscle mass, percent body fat, and segmental lean mass will be recorded. Participants with a pacemaker, an implantable cardioverter-defibrillator (ICD), or an automated ICD (AICD) will not be able to complete. At enrollment, participants 55 and older will undergo a submaximal exercise test to rule out significant undiagnosed cardiopulmonary disease (standard entrance criteria for pulmonary rehabilitation).
INTERVENTION: Participants will be asked to complete 2 1-hour exercise sessions per week for 8 weeks (16 total sessions) under the supervision of a licensed respiratory therapist in Rochester, MN on non-dialysis days unless the participant is on daily or near-daily dialysis (e.g. home hemodialysis or peritoneal dialysis). . The exercise sessions will be based on pulmonary rehabilitation and will follow guidelines established by the American Thoracic Society. Exercise sessions will include endurance (treadmill or cycle ergometer), strength, and flexibility training and will be tailored to individual participants.
- Conditions
- Kidney Transplant, Frailty
- Being tested
- Exercise Program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
Participants will be asked to complete 2 1-hour exercise sessions per week for 8 weeks (16 total sessions) under the supervision of a licensed respiratory therapist on non-dialysis days. The exercise program will be based on pulmonary rehabilitation and will follow guidelines established by the American Thoracic Society. Exercise sessions will include endurance (treadmill or cycle ergometer), strength (weight resistance), and flexibility training. Exercise sessions will be tailored to individual participants, and participant safety will be monitored during each session.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | All participants will attend a 16-session exercise program based on pulmonary rehabilitation and will complete questionnaires and frailty testing. Receives: Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frailty Status
Frailty will be determined by Frailty Phenotype (FP) or Short Physical Performance Battery (SPPB) scores. FP is determined by the presence of 3 or more of the following: slowness (measured by gait speed), exhaustion (measured with the CES-D), weakness (measured by hand grip strength), low physical activity level (measured with the MLTPAQ and activity monitoring), and wasting (measured through self-report or by tracking changes in weight). The SPPB consists of a gait speed test, balance testing, and repeated chair stands. A score less than or equal to 10 will be considered frail.
Measured: 2 Months
Secondary outcomes (8)
Change in Grip Strength
Hand grip strength will be measured using a hand-held dynamometer. Frailty is characterized as the lowest 20% by gender and body mass index.
Measured: 2 Months
Change in Gait Speed
Gait speed will be measured over a distance of 15 feet at the patient's self-selected walking speed. Frailty is characterized as the slowest 20% by gender and height. Results will be prorated for 4 meters for the SPPB score.
Measured: 2 Months
Change in Exhaustion
Patients will self-report their level of exhaustion using the Center for Epidemiologic Studies Depression Scale (CES-D) which consists of a 4-point scale. Items on the CES-D are scored from minimum to maximum values (1 point to 4 points) which are indicated on the CES-D as "rarely or none of the time," "some or a little of the time," "occasionally or a moderate amount of time," "most or all of the time," respectively. A higher number of points indicates a worse outcome.
Measured: 2 Months
Change in Activity
Energy expenditure will be measured using an activity monitor worn on the wrist for 5-7 days. Low activity is defined as activity in the lowest 20% (<383 Kcals/week for men or <270 Kcals/week for women). Patients will also self-report their activity level using the MLTPAQ.
Measured: 2 Months
Wasting
Wasting is defined as a decrease in lean body mass or unintentional weight loss of 10 or more pounds in one year.
Measured: 2 Months
Change in SPPB Score
The SPPB consists of a gait speed test, repeated chair stands, and balance testing. Lower scores indicate decreased physical function.
Measured: 2 Months
Change in Quality of Life
Health-related quality of life will be measured using the KDQOL-SF.
Measured: 2 Months
Post-Transplant Outcomes
The relationship between exercise, frailty status, and post-transplant outcomes will be examined for patients who receive a transplant within 1 year of enrolling in this study. The various outcome measures will be aggregated to indicate mortality rate up to one year post-transplant.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start12 Jun 2018
- Primary completion15 Jan 2025
- Study completion26 Mar 2025
Why it stopped: Enrollment was stopped due to covid-19 pandemic. An alternate study was initiated under an alternate IRB and clinical trial registration which allowed home exercise instead of in-center exercise after a prolonged pause in enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassie C. Kennedy, M.D., Mayo Clinic
- Investigators
- Cassie C Kennedy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535584
- Sponsor's protocol ID
- 17-009722
- Status last verified
- Mar 2025
- First submitted
- 3 May 2018
- Last updated
- 31 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lorenz EC, Hickson LJ, Hogan MC, Kennedy CC. Examining the safety and effectiveness of a 4-week supervised exercise intervention in the treatment of frailty in patients with chronic kidney disease. Clin Kidney J. 2023 Aug 9;16(11):2003-2010. doi: 10.1093/ckj/sfad192. eCollection 2023 Nov.
PubMed 37915911Lorenz EC, Hickson LJ, Weatherly RM, Thompson KL, Walker HA, Rasmussen JM, Stewart TL, Garrett JK, Amer H, Kennedy CC. Protocolized exercise improves frailty parameters and lower extremity impairment: A promising prehabilitation strategy for kidney transplant candidates. Clin Transplant. 2020 Sep;34(9):e14017. doi: 10.1111/ctr.14017. Epub 2020 Jul 24.
PubMed 32573816
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as an Intervention to Treat Frailty and Decreased Physical Function in Kidney Transplant Candidates
- ClinicalTrials.gov ID
- NCT03535584
- Acronym / sponsor ID
- 17-009722
- Conditions
- Kidney Transplant, Frailty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was stopped due to covid-19 pandemic. An alternate study was initiated under an alternate IRB and clinical trial registration which allowed home exercise instead of in-center exercise after a prolonged pause in enrollment.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 24 May 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.
Frailty is a condition characterized by slowness, weakness, low physical activity, wasting, and exhaustion. Frailty increases the risk for adverse outcomes following transplant such as increased length of stay in the hospital, mortality, or graft function. No interventions for frailty are known for patients with renal disease, but exercise programs like pulmonary rehabilitation have been effective in improving frailty in patients with other diseases, such as lung disease. The goal of this study is to test whether exercise will also improve frailty among patients who are waiting for a kidney transplant and who are considered frail or pre-frail.
Detailed description
RECRUITMENT: This study will be conducted at Mayo Clinic in Rochester, MN. Patients over 18 who have chronic kidney disease will be approached for recruitment. Interested patients will go through the informed consent process and, if frailty testing was not completed within the two weeks prior to consent, patients will complete frailty testing. If patients are considered frail or pre-frail, they will be enrolled in the study.
FRAILTY TESTING: Participants will complete the FP, Short Physical Performance Battery (SPPB) and other frailty testing at the beginning of the study, 4 weeks after beginning the intervention, and 8 weeks after beginning the intervention. Frailty testing will include a hand grip strength test, a gait speed test over 15 feet, repeated chair stands, balance testing, and a body composition scan. Participants will also be asked to wear an activity monitor for 5-7 days at each testing point and to complete a set of questionnaires. Height, weight, BMI, skeletal muscle mass, percent body fat, and segmental lean mass will be recorded. Participants with a pacemaker, an implantable cardioverter-defibrillator (ICD), or an automated ICD (AICD) will not be able to complete. At enrollment, participants 55 and older will undergo a submaximal exercise test to rule out significant undiagnosed cardiopulmonary disease (standard entrance criteria for pulmonary rehabilitation).
INTERVENTION: Participants will be asked to complete 2 1-hour exercise sessions per week for 8 weeks (16 total sessions) under the supervision of a licensed respiratory therapist in Rochester, MN on non-dialysis days unless the participant is on daily or near-daily dialysis (e.g. home hemodialysis or peritoneal dialysis). . The exercise sessions will be based on pulmonary rehabilitation and will follow guidelines established by the American Thoracic Society. Exercise sessions will include endurance (treadmill or cycle ergometer), strength, and flexibility training and will be tailored to individual participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Behavioral: Exercise ProgramAll participants will attend a 16-session exercise program based on pulmonary rehabilitation and will complete questionnaires and frailty testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Consenting to research
- CKD (stages 1-5)
- An SPPB score ≤10 or considered frail or pre-frail by FP
Key exclusion criteria (8 listed)
- Younger than 18 years
- Patients listed for heart or lung transplants
- Terminal illness with a prognosis of less than 6 months
- Significant comorbidities that limit rehabilitation potential including pulmonary disease requiring continuous oxygen supplementation, active angina, critical aortic sclerosis, decompensated heart failure, or known ventricular arrhythmia.
- Kidney transplant candidates without cardiac clearance for transplant
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 ProgramParticipants will be asked to complete 2 1-hour exercise sessions per week for 8 weeks (16 total sessions) under the supervision of a licensed respiratory therapist on non-dialysis days. The exercise program will be based on pulmonary rehabilitation and will follow guidelines established by the American Thoracic Society. Exercise sessions will include endurance (treadmill or cycle ergometer), strength (weight resistance), and flexibility training. Exercise sessions will be tailored to individual participants, and participant safety will be monitored during each session. | Behavioural | Exercise Program |
Primary outcome
Change in Frailty Status
Time frame: 2 Months
Frailty will be determined by Frailty Phenotype (FP) or Short Physical Performance Battery (SPPB) scores. FP is determined by the presence of 3 or more of the following: slowness (measured by gait speed), exhaustion (measured with the CES-D), weakness (measured by hand grip strength), low physical activity level (measured with the MLTPAQ and activity monitoring), and wasting (measured through self-report or by tracking changes in weight). The SPPB consists of a gait speed test, balance testing, and repeated chair stands. A score less than or equal to 10 will be considered frail.
8 secondary outcomes
Change in Grip Strength
Time frame: 2 Months
Change in Gait Speed
Time frame: 2 Months
Change in Exhaustion
Time frame: 2 Months
Change in Activity
Time frame: 2 Months
Wasting
Time frame: 2 Months
Change in SPPB Score
Time frame: 2 Months
Change in Quality of Life
Time frame: 2 Months
Post-Transplant Outcomes
Time frame: 1 Year
Results and safety
The study was stopped early (reason given: Enrollment was stopped due to covid-19 pandemic. An alternate study was initiated under an alternate IRB and clinical trial registration which allowed home exercise instead of in-center exercise after a prolonged pause in enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2025.
- Derived from this study: PubMed 37915911Lorenz EC, Hickson LJ, Hogan MC, Kennedy CC. Examining the safety and effectiveness of a 4-week supervised exercise intervention in the treatment of frailty in patients with chronic kidney disease. Clin Kidney J. 2023 Aug 9;16(11):2003-2010. doi: 10.1093/ckj/sfad192. eCollection 2023 Nov.
- Derived from this study: PubMed 32573816Lorenz EC, Hickson LJ, Weatherly RM, Thompson KL, Walker HA, Rasmussen JM, Stewart TL, Garrett JK, Amer H, Kennedy CC. Protocolized exercise improves frailty parameters and lower extremity impairment: A promising prehabilitation strategy for kidney transplant candidates. Clin Transplant. 2020 Sep;34(9):e14017. doi: 10.1111/ctr.14017. Epub 2020 Jul 24.
- 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.
Cassie C Kennedy, MD principal investigator
Mayo Clinic
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 Program in people with Kidney Transplant and Frailty, run by Mayo Clinic 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: stopped early, as of the sponsor's last update on 31 Mar 2025. 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 was stopped early (reason given: Enrollment was stopped due to covid-19 pandemic. An alternate study was initiated under an alternate IRB and clinical trial registration which allowed home exercise instead of in-center exercise after a prolonged pause in enrollment.). Results are not available in the source record.
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 Frailty Status (time frame: 2 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 NCT03535584, 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 31 Mar 2025.