Trial Outcomes & Findings for Home-Based Exercise to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function (NCT NCT04745169)

Results Overview

The Short Physical Performance Battery is a composite measure which includes component tests of balance, gait speed, and chair stand time. Participants receive a score of 0-4 for each of the 3 component tests with lower scores indicating worse physical function. Component scores are then summed providing a total score of 0-12 with lower scores again indicating worse physical function.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

8 weeks of home-based exercise

Results posted on

2025-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Participants will be asked to complete an 8-week home-based exercise intervention 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.
Overall Study STARTED	15
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Participants will be asked to complete an 8-week home-based exercise intervention 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.
Overall Study Kidney transplantation	1
Overall Study Participant health problems	3
Overall Study Physician Decision	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=15 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized White race	11 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Dialysis dependent	8 Participants n=5 Participants
Diabetes	12 Participants n=5 Participants
Never smoked	10 Participants n=5 Participants
Body mass index	30.3 kg/m^2 n=5 Participants
Physical Frailty Phenotype score	2 units on a scale n=5 Participants
Short Physical Performance Battery score	9 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks of home-based exercise

Population: Median difference in 8-week score compared to baseline score

The Short Physical Performance Battery is a composite measure which includes component tests of balance, gait speed, and chair stand time. Participants receive a score of 0-4 for each of the 3 component tests with lower scores indicating worse physical function. Component scores are then summed providing a total score of 0-12 with lower scores again indicating worse physical function.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Short Physical Performance Battery Score	-1 units on a scale Interval -2.0 to 1.5

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in 8-week grip strength compared to baseline

Grip strength will be measured using a hand-held dynamometer.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Grip Strength	2.8 kilograms Interval 0.2 to 6.3

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in 8-week gait speed compared to baseline

Gait speed at the participant's self-selected walking speed will be measured.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Gait Speed	-0.1 meters/second Interval -0.3 to 0.2

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in 8-week energy/fatigue score compared to baseline score

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. Energy/fatigue scores range from 0 to 100 points with a higher number of points indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Exhaustion	10.0 score on a scale Interval -5.0 to 20.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in moderate to vigorous physical activity at 8-week score compared to baseline

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.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Physical Activity	-0.4 hours per day Interval -1.3 to 0.4

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in 8-week mental health score compared to baseline score

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.

Outcome measures

Outcome measures
Measure	Intervention n=8 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Quality of Life	1.7 score on a scale Interval -9.4 to 8.4

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in 8-week weight compared to baseline

Weight will be measured using a scale.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Weight	-1.1 kilograms Interval -2.1 to 0.2

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in 8-week percent body fat compared to baseline

Change in percent body fat from baseline to 8 weeks was measured in the subset of participants from Mayo Clinic using bioelectrical impedance analysis.

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Percent Body Fat	0.9 percentage of body fat Interval 0.0 to 1.3

SECONDARY outcome

Timeframe: 8 weeks

Population: Median difference in 8-week score compared to baseline score

The Physical Frailty Phenotype score is based on 5 criteria: unintentional weight loss, exhaustion, low physical activity, slowness, weakness. Participants receive a score of 1 for each criterion they meet. The criterion scores are then summed to provide a total score ranging from 0-5 with higher scores indicating greater frailty. Specifically, a total score of 0 indicates that the participant is not frail, a score of 1-2 indicates that the participant is pre-frail, and a score of 3-5 indicates that the participant is frail.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Participants will be asked to complete an 8-week home-based exercise intervention 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.
Change in Physical Frailty Phenotype	0 units on a scale Interval -1.0 to 0.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=15 participants at risk Participants will be asked to complete an 8-week home-based exercise intervention 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.
Musculoskeletal and connective tissue disorders Transient musculoskeletal pain	6.7% 1/15 • Number of events 1 • 8 weeks
Musculoskeletal and connective tissue disorders Persistent musculoskeletal pain	6.7% 1/15 • Number of events 1 • 8 weeks
Respiratory, thoracic and mediastinal disorders Shortness of breath	6.7% 1/15 • Number of events 1 • 8 weeks

Additional Information

Elizabeth Lorenz, MD

Baylor College of Medicine

Phone: 713-798-2694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place