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Strength Training in Walking Tolerance in Intermittent Claudication Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00879697
First received: January 27, 2009
Last updated: April 9, 2009
Last verified: April 2009

January 27, 2009
April 9, 2009
July 2005
August 2008   (final data collection date for primary outcome measure)
Total Walking Distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Total Walking Distance [ Time Frame: January 2008 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00879697 on ClinicalTrials.gov Archive Site
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Not Provided
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Strength Training in Walking Tolerance in Intermittent Claudication Patients
Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication

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

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 at 2 miles per hour, were invited to a meeting at which explanations about this study were given. 80 patients attended the meeting, 60 of them decided to take part of the study, and 52 attended for the screening tests.

Patients were included in the study if they met the following criteria: Fontaine stage II peripheral arterial disease, symptoms of IC for at least 6 months, ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs, reduction of ABI after treadmill test, and exercise tolerance limited by IC. Patients were excluded under the following conditions: presence of chronic lung disease, inability to obtain ABI measurement due to noncompressible vessels, exercise tolerance limited by factors other than claudication (eg, dyspnea or orthopedic problems), poorly controlled blood pressure, presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test, and history of revascularization in the previous year.

Procedures Patients were randomly (by drawing lots) divided into 2 groups: strength (ST, n = 17) and walking (WT, n = 17) training. They were evaluated at baseline (pre-training) and after 12 weeks of exercise training (post-training). During evaluations were assessed exercise tolerance and strength.

Both training programs (ST and WT) were supervised, conducted twice a week, lasted for 12 weeks, and started after a 2-week preconditioning-orientation phase. In both programs, rate of perceived exertion during exercise was kept similar and between 11 to 13 on the15-grade Borg scale. Furthermore, the duration of exercise sessions was prescribed as 30 min of exercise for ST and WT groups.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Arterial Disease
  • Hypertension
  • Diabetes
  • Behavioral: Walking Training Program
    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 s of each exercise bout.
    Other Names:
    • Walk training
    • Walk exercise
  • Behavioral: Strength Training Program
    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.
    Other Names:
    • Resistance training
    • Weight training
  • Active Comparator: Strength training
    Patients who performed strength training. The strength training program was composed by 8 exercises for whole body performed at sub-maximal intensity prescribed according to the patients self-perceived effort
    Intervention: Behavioral: Strength Training Program
  • Active Comparator: Walking training
    Patients who performed walking training. The walking training was performed in a treadmill using sub-maximal intensity prescribed based in patients self perceived effort
    Intervention: Behavioral: Walking Training Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
December 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00879697
44444
Yes
University of São Paulo, Public Health Center
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Maria FN Marucci, PhD University of Sao Paulo
University of Sao Paulo
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP