Exercise to Treat Frailty and Decreased Physical Function in Transplant Candidates

NCT03535584 | Terminated

• 1 other identifier: 17-009722
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Frailty

Outcome Measures

Primary Outcomes (1)

• 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.

  2 Months

Secondary Outcomes (8)

• Change in Grip Strength

  2 Months

• Change in Gait Speed

  2 Months

• Change in Exhaustion

  2 Months

• Change in Activity

  2 Months

• Wasting

  2 Months

Study Arms (1)

Exercise Program

EXPERIMENTAL

All participants will attend a 16-session exercise program based on pulmonary rehabilitation and will complete questionnaires and frailty testing.

Behavioral: Exercise Program

Interventions

Exercise Program BEHAVIORAL

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.

Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (2)

• 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.

  PMID: 37915911 DERIVED

• 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.

  PMID: 32573816 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cassie C Kennedy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 24, 2018
• Study Start: June 12, 2018
• Primary Completion: January 15, 2025
• Study Completion: March 26, 2025
• Last Updated: March 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)