Clinical trial NCT03535584: Exercise to Treat Frailty and Decreased Physical Function in Transplant Candidates
Official title: Exercise as an Intervention to Treat Frailty and Decreased Physical Function in Kidney Transplant Candidates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Transplant
Frailty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Consenting to research
* CKD (stages 1-5)
* An SPPB score ≤10 or considered frail or pre-frail by FP

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Frailty Status
timeFrame: 2 Months
Secondary outcomes:
measure: Change in Grip Strength
timeFrame: 2 Months
measure: Change in Gait Speed
timeFrame: 2 Months
measure: Change in Exhaustion
timeFrame: 2 Months
measure: Change in Activity
timeFrame: 2 Months
measure: Wasting
timeFrame: 2 Months
measure: Change in SPPB Score
timeFrame: 2 Months
measure: Change in Quality of Life
timeFrame: 2 Months
measure: Post-Transplant Outcomes
timeFrame: 1 Year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cassie C Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorenz 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.