CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 34 enrolled
Drug / intervention
Walking Training +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT00879697
NCT00879697Phase 3Completed

Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication

University of Sao Paulo·interventional·Posted Apr 10, 2009·Updated Dec 15, 2016

In Brief

A Phase 3 clinical trial evaluating Walking Training and Strength Training for Peripheral Arterial Disease and 2 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed Summary

Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in patients with intermittent claudication (IC), suggesting that strength training (ST) could improve exercise performance in these patients. Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with walking training (WT) effects. Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for 12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2 minutes of resting. Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic window and knee extension strength

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2009
Enrollment StartJul 1, 2005
Primary CompletionAug 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.2 years ago

Interventions

Walking Trainingbehavioral

The Walking Training program was performed using a treadmill. In each session, patients performed fifteen 2-min bouts of exercise followed by a 2-min 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 of each exercise bout.

Strength Trainingbehavioral

The 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-min interval between sets and exercises.