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Exercise to Treat Frailty and Decreased Physical Function in Transplant Candidates

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ClinicalTrials.gov Identifier: NCT03535584
Recruitment Status : Suspended (Due to Covid19 pandemic at this time we are on pause)
First Posted : May 24, 2018
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Cassie C. Kennedy, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Frailty Behavioral: Exercise Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise as an Intervention to Treat Frailty and Decreased Physical Function in Kidney Transplant Candidates
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Program
All participants will attend a 16-session exercise program based on pulmonary rehabilitation and will complete questionnaires and frailty testing.
Behavioral: Exercise Program
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Grip Strength [ Time Frame: 2 Months ]
    Hand grip strength will be measured using a hand-held dynamometer. Frailty is characterized as the lowest 20% by gender and body mass index.

  2. Change in Gait Speed [ Time Frame: 2 Months ]
    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.

  3. Change in Exhaustion [ Time Frame: 2 Months ]
    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.

  4. Change in Activity [ Time Frame: 2 Months ]
    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.

  5. Wasting [ Time Frame: 2 Months ]
    Wasting is defined as a decrease in lean body mass or unintentional weight loss of 10 or more pounds in one year.

  6. Change in SPPB Score [ Time Frame: 2 Months ]
    The SPPB consists of a gait speed test, repeated chair stands, and balance testing. Lower scores indicate decreased physical function.

  7. Change in Quality of Life [ Time Frame: 2 Months ]
    Health-related quality of life will be measured using the KDQOL-SF.

  8. Post-Transplant Outcomes [ Time Frame: 1 Year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535584


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Cassie C Kennedy, MD Mayo Clinic
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cassie C. Kennedy, M.D., Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03535584    
Other Study ID Numbers: 17-009722
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes