Phase 3 N=34 Randomized Treatment

Strength Training in Walking Tolerance in Intermittent Claudication Patients

Peripheral Arterial Disease · Hypertension · Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00879697 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2009

Primary outcome: Primary: Total Walking Distance — 618; 572 meter — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Walking Training (Behavioral); Strength Training (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Sao Paulo
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Walking Distance	618; 572	<0.05 sig

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

Eligibility Criteria

Inclusion Criteria

Fontaine stage II peripheral arterial disease(14)
Symptoms of intermittent claudication for at least 6 months
Ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs
Reduction of ABI after treadmill test
Exercise tolerance limited by intermittent claudication

Exclusion Criteria

Presence of chronic lung disease
Inability to obtain ABI measurement due to noncompressible vessels
Exercise tolerance limited by factors other than claudication (e.g., dyspnea or orthopedic problems)
Poorly controlled blood pressure
Presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test
History of revascularization in the previous year

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Data sourced from ClinicalTrials.gov (NCT00879697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.