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
  Purpose

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


Condition Intervention Phase
Peripheral Arterial Disease
Hypertension
Diabetes
Behavioral: Walking Training Program
Behavioral: Strength Training Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Total Walking Distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: 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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00879697

Locations
Brazil
Raphael Dias
São Paulo, Brazil, 05588000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Maria FN Marucci, PhD University of Sao Paulo
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of São Paulo, Public Health Center
ClinicalTrials.gov Identifier: NCT00879697     History of Changes
Other Study ID Numbers: 44444
Study First Received: January 27, 2009
Results First Received: January 27, 2009
Last Updated: April 9, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
peripheral arterial disease
exercise
resistance training
cardiac rehabilitation

Additional relevant MeSH terms:
Hypertension
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014