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Home-Based Exercise as an Intervention to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function

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ClinicalTrials.gov Identifier: NCT04745169
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Elizabeth C. Lorenz, Mayo Clinic

Study Description
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Brief Summary:
The investigators will conduct a pilot study to determine whether home-based exercise is an effective intervention to improve decreased physical function in kidney transplant candidates. The investigators will determine if home-based exercise improves frailty parameters and SPPB scores. The investigators will also determine if home-based exercise improves health-related quality of life (HRQOL), body composition, physical activity, and adverse clinical outcomes, including hospitalizations.

Condition or disease Intervention/treatment Phase
Kidney Transplant Candidates Behavioral: 8 week home-based exercise program Not Applicable

Detailed Description:

Screening and Recruitment:

Potential participants undergoing outpatient kidney transplant evaluation at Mayo Clinic Rochester will be identified. Patients who express interest in the study will go through the informed consent process with a member of the study team, and patients wishing to participate in the study will complete written consent. If patients have not had frailty and SPPB testing within the two weeks prior to consent, the study team member will perform frailty and SPPB testing at baseline in a supervised setting. Patients who are not frail or pre-frail and have a SPPB score > 10 will be ineligible for study participation.

Exercise Intervention:

Participants will be provided with a pedal exerciser, resistance bands, and exercise pamphlets. Participants will be asked to complete an 8-week home-based exercise program with a focus on the core components of physical activity counseling and exercise training according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. Participants will receive an individualized exercise prescription. Recommended aerobic exercises will include arm and/or leg ergometry using a pedal exerciser, and recommended resistance training will include resistance bands. During the program, participants will receive weekly semi-scripted phone calls from an exercise physiologist and gradual increases in the volume of physical activity will be recommended over time. Participants will be asked to log information regarding their exercise sessions.

Study Measures:

Participants will complete the Short Physical Performance Battery (SPPB), and Fried Frailty phenotype at baseline and after completion of the exercise intervention. The SPPB consists of gait speed, balance, and repeat chair stand tests. The Fried Frailty Phenotype consists of gait speed and grip strength tests, in addition to self-reported measurement of physical activity, weight loss, and exhaustion. Participants will also be asked to complete a body composition scan, complete questionnaires, and wear a physical activity monitor at baseline and after completion of the exercise intervention.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study to be conducted at Mayo Clinic in Rochester, MN examining the feasibility, safety, acceptability, and preliminary efficacy of home-based exercise on frailty parameters and SPPB score in patients with varying levels of kidney function. The effects of exercise on HRQOL, body composition, physical activity, and adverse outcomes including hospitalizations, will also be explored.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Home-Based Exercise as an Intervention to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Intervention
Participants will be asked to complete an 8-week home-based exercise intervention
 Behavioral: 8 week home-based exercise program
Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Short Physical Performance Battery score [ Time Frame: 8 weeks of home-based exercise ]
    The Short Physical Performance Battery consists of gait speed, balance, and repeated chair stand tests. The minimum score is 0, and the maximum score is 12. Higher scores indicate better physical function.


Secondary Outcome Measures :
  1. Change in grip strength [ Time Frame: 8 weeks ]
    Grip strength will be measured using a hand-held dynamometer.

  2. Change in gait speed [ Time Frame: 8 weeks ]
    Gait speed at the participant's self-selected walking speed will be measured.

  3. Change in exhaustion [ Time Frame: 8 weeks ]
    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 physical activity [ Time Frame: 8 weeks ]
    Energy expenditure will be measured using an activity monitor worn on the wrist for 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 Minnesota Leisure Time Physical Activity Questionnaire.

  5. Wasting [ Time Frame: 8 weeks ]
    Wasting is defined as an unintentional weight loss of 10 or more pounds in one year.

  6. Change in quality of life [ Time Frame: 8 weeks ]
    Health-related quality of life will be measured using the Kidney Disease Quality of Life Short Form. This questionnaire includes scales with minimum values of 0 and maximum values of 100. Higher scores indicate better quality of life.

  7. Change in free fat mass [ Time Frame: 8 weeks ]
    Free fat mass will be assessed using a body composition scan utilizing electrical impedance.

  8. Post-transplant 30-day rehospitalizations [ Time Frame: 1 year ]
    The relationship between exercise, physical function, and post-transplant 30-day rehospitalizations will be examined for patients who receive a kidney transplant within 1 year of enrolling in this study.


Eligibility Criteria
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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:

  • Age 18 years or older
  • Consenting to research
  • Approved for kidney transplant at Mayo Clinic -OR- Chronic kidney disease (stages 1-5)
  • An SPPB score ≤10 or considered frail or pre-frail according to the Fried Frailty Phenotype

Exclusion Criteria:

  • Younger than 18 years
  • Patients being evaluated for combined organ transplantation
  • 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.
  • An SPPB score >10 or not considered frail or pre-frail by the Fried Frailty Phenotype
  • Non-English speaker without availability of adequate interpreter services (safety concern)
  • Failure to pass submaximal exercise test in patients not approved for kidney transplantation at our center
Contacts and Locations
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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): NCT04745169


Contacts
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Contact: Julie Gecox Hanson, CCRP 507-293-6592 gecox.julie@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Julie Gecox Hanson, CCRP    507-293-6592    gecox.julie@mayo.edu   
Principal Investigator: Elizabeth C Lorenz, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Elizabeth C Lorenz, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Elizabeth C. Lorenz, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04745169    
Other Study ID Numbers: 20-009666
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No