Trial Outcomes & Findings for Exercise and Weight Loss in PAD (NCT NCT02607033)
NCT ID: NCT02607033
Last Updated: 2024-06-17
Results Overview
The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
6 months
Results posted on
2024-06-17
Participant Flow
Participant milestones
| Measure |
Exercise and Weight Loss
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
|
Exercise
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise and Weight Loss in PAD
Baseline characteristics by cohort
| Measure |
Exercise and Weight Loss
n=9 Participants
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
|
Exercise
n=9 Participants
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
72 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 6 individuals in the exercise and weight loss group and 2 individuals in the exercise group completed pre/post measures for Claudication onset time
The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention
Outcome measures
| Measure |
Exercise and Weight Loss
n=6 Participants
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
|
Exercise
n=2 Participants
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
|
|---|---|---|
|
Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention
|
396 seconds
Interval 264.0 to 524.0
|
140 seconds
Interval 106.0 to 175.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 6 individuals in the exercise and weight loss group and 2 individuals in the exercise group completed pre/post measures for ankle brachial index
A change in the muscle blood flow to the legs determined by taking blood pressure in the arms and legs before and after cessation of exercise comparing the change pre to post exercise scores pre-intervention (baseline) and post intervention (6 months). There are no units because the ankle brachial index is a ratio. An improvement would be a higher number a post-intervention testing than pre-intervention testing. A negative number indicates improvement while a positive number indicates a worse score post-testing.
Outcome measures
| Measure |
Exercise and Weight Loss
n=6 Participants
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
|
Exercise
n=2 Participants
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
|
|---|---|---|
|
Difference in Ankle Brachial Index Pre-intervention to Post-intervention
|
0.04 ratio
Interval -0.15 to 0.27
|
-0.16 ratio
Interval -0.18 to -0.14
|
SECONDARY outcome
Timeframe: 6 monthsA mobility measure that utilizes 9 tasks scored 0-4 (total possible score 36) to determine functional status. Scores from each of the nine items are summed for the total score. Scores are from 0-36 with higher scores considered to be better. The post-testing median score will be reported for post-testing.
Outcome measures
| Measure |
Exercise and Weight Loss
n=7 Participants
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
|
Exercise
n=2 Participants
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
|
|---|---|---|
|
Score on the Modified Physical Performance Test Post-intervention
|
33 score on a scale
Interval 30.0 to 36.0
|
31 score on a scale
Interval 26.0 to 36.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This measure was not conducted due to staffing and pandemic related limitations in acquiring the CT scans.
A measure of the amount of muscle and fat in the muscle using a CT scan of the legs. Pre-test levels will be compared to post-test levels.
Outcome measures
Outcome data not reported
Adverse Events
Exercise and Weight Loss
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Exercise
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise and Weight Loss
n=9 participants at risk
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
|
Exercise
n=9 participants at risk
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
11.1%
1/9 • Number of events 1 • 6 months from baseline
|
0.00%
0/9 • 6 months from baseline
|
|
Cardiac disorders
angina
|
11.1%
1/9 • Number of events 1 • 6 months from baseline
|
11.1%
1/9 • Number of events 1 • 6 months from baseline
|
|
Cardiac disorders
Coronary Artery Bypass Graft (CABG)
|
0.00%
0/9 • 6 months from baseline
|
11.1%
1/9 • Number of events 1 • 6 months from baseline
|
|
Gastrointestinal disorders
Gastrointestinal (GI) bleed
|
0.00%
0/9 • 6 months from baseline
|
11.1%
1/9 • Number of events 1 • 6 months from baseline
|
Other adverse events
| Measure |
Exercise and Weight Loss
n=9 participants at risk
Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight Loss: Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
|
Exercise
n=9 participants at risk
Individuals assigned to this group will be asked to complete the exercise intervention for xic months
Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
11.1%
1/9 • Number of events 1 • 6 months from baseline
|
0.00%
0/9 • 6 months from baseline
|
|
Infections and infestations
Infection
|
33.3%
3/9 • Number of events 5 • 6 months from baseline
|
22.2%
2/9 • Number of events 3 • 6 months from baseline
|
|
Social circumstances
Car accident
|
0.00%
0/9 • 6 months from baseline
|
11.1%
1/9 • Number of events 1 • 6 months from baseline
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place