Home-Based Exercise to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
- Conditions
- Chronic Kidney Disease
- Interventions
- Behavioral: 8 week home-based exercise program
- Registration Number
- NCT04745169
- Lead Sponsor
- Baylor College of Medicine
- 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), physical activity, and adverse clinical outcomes, including hospitalizations.
- Detailed Description
Screening and Recruitment:
Potential participants will be identified from dialysis units, nephrology clinics, primary care clinics, or kidney transplant clinics at Baylor College of Medicine. 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 questionnaires and wear a physical activity monitor at baseline and after completion of the exercise intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Age 18 years or older
- Consenting to research
- Chronic kidney disease (stages 1-5)
- An SPPB score ≤10 or considered frail or pre-frail according to the Fried Frailty Phenotype
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention 8 week home-based exercise program Participants will be asked to complete an 8-week home-based exercise intervention
- Primary Outcome Measures
Name Time Method Change in Short Physical Performance Battery score 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
Name Time Method Change in grip strength 8 weeks Grip strength will be measured using a hand-held dynamometer.
Change in gait speed 8 weeks Gait speed at the participant's self-selected walking speed will be measured.
Change in exhaustion 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. Energy/fatigue scores on the Kidney Disease Quality of Life Short Form (KDQOL-SF) will also be calculated.
Change in physical activity 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.
Wasting 8 weeks Wasting is defined as an unintentional weight loss of 10 or more pounds in one year.
Change in quality of life 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.
Change in weight 8 weeks Weight will be measured using a scale.
Change in percent body fat 8 weeks Change in percent body fat from baseline to 8 weeks was measured in the subset of participants from Mayo Clinic using bioelectrical impedance analysis.
Change in Physical Frailty Phenotype 8 weeks The Physical Frailty Phenotype consists of five criteria: unintentional weight loss over the past year, self-reported exhaustion, low physical activity, slow walking speed, and weak grip strength. Participants meeting ≥ 3 criteria were defined as frail, participants meeting 1-2 criteria were defined as pre-frail, and participants meeting no criteria were defined as not frail.
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States