Trial Outcomes & Findings for Daily Step-based Exercise Using Fitness Monitors for Peripheral Artery Disease (NCT NCT03099369)

Results Overview

At baseline, both groups will be instructed to wear their fitness monitors for 7 consecutive days. After 3 months of the exercise program, both groups will be instructed to wear their fitness monitors for 7 consecutive days. During each 7-day period, all patients will be instructed to walk continuously for at least one extended period of time on a daily basis. Given that this is a pilot study, the duration and frequency of these extended periods of time will be at the patients' discretion. The change in the mean daily walking distance at 3 months will be the primary outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline, Month 3

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Daily Step-based Exercise Group The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor will be used for tracking. * Week 1: walk at least 3,000 steps every day. * Week 2: walk at least 3,500 steps every day. * Week 3: walk at least 4,000 steps every day. * Week 4: walk at least 4,500 steps every day. * Weeks 5-12: walk at least 5,000 steps every day. Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only	Symptom-based Exercise Group The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines). * Walk on a flat surface at a constant speed until there is mild to moderate pain * Rest until the pain has completely ceased * Resume walking at the same speed * Increase the speed when you can walk 8 minutes without stopping for leg symptoms * Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week. Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
Overall Study STARTED	11	9
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Step-based Exercise Group n=11 Participants The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor will be used for tracking. * Week 1: walk at least 3,000 steps every day. * Week 2: walk at least 3,500 steps every day. * Week 3: walk at least 4,000 steps every day. * Week 4: walk at least 4,500 steps every day. * Weeks 5-12: walk at least 5,000 steps every day. Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only	Symptom-based Exercise Group n=9 Participants The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines). * Walk on a flat surface at a constant speed until there is mild to moderate pain * Rest until the pain has completely ceased * Resume walking at the same speed * Increase the speed when you can walk 8 minutes without stopping for leg symptoms * Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week. Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only	Total n=20 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 8.5 • n=11 Participants	58.6 years STANDARD_DEVIATION 16.5 • n=9 Participants	60.6 years STANDARD_DEVIATION 12.6 • n=20 Participants
Sex: Female, Male Female	6 Participants n=11 Participants	5 Participants n=9 Participants	11 Participants n=20 Participants
Sex: Female, Male Male	5 Participants n=11 Participants	4 Participants n=9 Participants	9 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	11 Participants n=11 Participants	9 Participants n=9 Participants	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Data were not collected for 10 participants because of their inability to complete prescribed exercise program or to upload Fitbit data.

At baseline, both groups will be instructed to wear their fitness monitors for 7 consecutive days. After 3 months of the exercise program, both groups will be instructed to wear their fitness monitors for 7 consecutive days. During each 7-day period, all patients will be instructed to walk continuously for at least one extended period of time on a daily basis. Given that this is a pilot study, the duration and frequency of these extended periods of time will be at the patients' discretion. The change in the mean daily walking distance at 3 months will be the primary outcome.

Outcome measures

Outcome measures
Measure	Daily Step-based Exercise Group n=5 Participants The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor used for tracking. * Week 1: walk at least 3,000 steps every day. * Week 2: walk at least 3,500 steps every day. * Week 3: walk at least 4,000 steps every day. * Week 4: walk at least 4,500 steps every day. * Weeks 5-12: walk at least 5,000 steps every day. Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only	Symptom-based Exercise Group n=5 Participants The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines). * Walk on a flat surface at a constant speed until there is mild to moderate pain * Rest until the pain has completely ceased * Resume walking at the same speed * Increase the speed when you can walk 8 minutes without stopping for leg symptoms * Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week. Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
Change in the Mean Daily Walking Distance Over 7 Consecutive Days	754.2 steps Standard Deviation 1621.7	-1160 steps Standard Deviation 2963.2

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: None of the participants could be reached to obtain both baseline and endpoint telephone survey data. Therefore, data for this outcome measure are unavailable.

At baseline, both groups will be asked to complete the Peripheral Artery Questionnaire (PAQ), which is a quality-of-life survey with a summary score ranging from 0 to 100 (with 100 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the PAQ again. The change in the summary score at 3 months will the secondary outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: None of the participants could be reached to obtain both baseline and endpoint telephone survey data. Therefore, data for this outcome measure are unavailable.

At baseline, both groups will be asked to complete the Vascular Quality of Life Questionnaire (VascuQol), which is a quality-of-life survey with a summary score ranging from 25 to 175 (with 175 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the VascuQol survey again. The change in the summary score at 3 months will the secondary outcome.

Outcome measures

Outcome data not reported

Adverse Events

Daily Step-based Exercise Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Symptom-based Exercise Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Lee, MD

University of North Carolina at Chapel Hill

Phone: 347-882-8010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place