Trial Outcomes & Findings for Strength Training in Walking Tolerance in Intermittent Claudication Patients (NCT NCT00879697)

NCT ID: NCT00879697

Last Updated: 2016-12-15

Results Overview

The maximal walking distance

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 34 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2016-12-15

Participant Flow

From July 2005 to December 2006, three hundred patients with peripheral arterial disease, who were enrolled in a tertiary center specialized in vascular disease and were able to walk for at least 2 minutes (min) at 2 miles per hour (mph), were invited to a meeting at which explanations about this study were given.

Seven patients did not present symptoms of claudication during the treadmill test, 5 presented electrocardiogram response suggestive of myocardial ischemia, 4 presented exercise tolerance limited by other factors than claudication, and 2 presented poorly controlled blood pressure. All these patients were not included in the study.

Participant milestones

Measure	Strength Training Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.	Walking Training Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds (s) of each exercise bout.
Overall Study STARTED	17	17
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Strength Training Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.	Walking Training Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds (s) of each exercise bout.
Overall Study Physician Decision	2	2

Baseline Characteristics

Strength Training in Walking Tolerance in Intermittent Claudication Patients

Baseline characteristics by cohort

Measure	Strength Training n=17 Participants Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.	Walking Training n=17 Participants Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical >=65 years	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Age, Continuous	65.7 years STANDARD_DEVIATION 9.5 • n=93 Participants	64.6 years STANDARD_DEVIATION 8.8 • n=4 Participants	65.1 years STANDARD_DEVIATION 9.3 • n=27 Participants
Gender Female	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Gender Male	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Region of Enrollment Brazil	17 participants n=93 Participants	17 participants n=4 Participants	34 participants n=27 Participants
Total walking distance	618 meter STANDARD_DEVIATION 282 • n=93 Participants	572 meter STANDARD_DEVIATION 231 • n=4 Participants	595 meter STANDARD_DEVIATION 244 • n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

The maximal walking distance

Outcome measures

Measure	Strength Training n=15 Participants Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.	Walking Training n=15 Participants Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
Total Walking Distance	618 meter Standard Deviation 282	572 meter Standard Deviation 231

Adverse Events

Strength Training

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Walking Training

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Strength Training n=17 participants at risk Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.	Walking Training n=17 participants at risk Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
Nervous system disorders Inguinal hernia	5.9% 1/17 • Number of events 1 • 12 weeks	0.00% 0/17 • 12 weeks
Gastrointestinal disorders Gastrointestinal problems	5.9% 1/17 • Number of events 1 • 12 weeks	0.00% 0/17 • 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diagnose Lung cancer	0.00% 0/17 • 12 weeks	5.9% 1/17 • Number of events 1 • 12 weeks
Vascular disorders Diagnose aneurysm	0.00% 0/17 • 12 weeks	5.9% 1/17 • Number of events 1 • 12 weeks

Additional Information

Raphael Dias

University of São Paulo

Phone: 55 81 9728 6878

Email: raphaelritti@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place