Strength Training in Walking Tolerance in Intermittent Claudication Patients

NCT00879697 | Completed Phase 3 Results DMC

• 1 other identifier: 44444
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Peripheral Arterial Disease; Hypertension; Diabetes

Keywords

peripheral arterial disease; exercise; resistance training; cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• Total Walking Distance

  The maximal walking distance

  12 weeks

Study Arms (2)

Strength training

ACTIVE COMPARATOR

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

Walking training

ACTIVE COMPARATOR

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

Interventions

Walking Training BEHAVIORAL

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.

Also known as: Walk training, Walk exercise

Walking training

Strength Training BEHAVIORAL

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.

Also known as: Resistance training, Weight training

Strength training

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Raphael Dias

São Paulo, São Paulo, 05588000, Brazil

Location

Related Publications (3)

• Dias RM, Forjaz CL, Cucato GG, Costa LA, Camara LC, Wolosker N, Marucci Mde F. Obesity decreases time to claudication and delays post-exercise hemodynamic recovery in elderly peripheral arterial disease patients. Gerontology. 2009;55(1):21-6. doi: 10.1159/000155219. Epub 2008 Sep 11.

  PMID: 18784409 RESULT

• Grizzo Cucato G, de Moraes Forjaz CL, Kanegusuku H, da Rocha Chehuen M, Riani Costa LA, Wolosker N, Kalil Filho R, de Fatima Nunes Marucci M, Mendes Ritti-Dias R. Effects of walking and strength training on resting and exercise cardiovascular responses in patients with intermittent claudication. Vasa. 2011 Sep;40(5):390-7. doi: 10.1024/0301-1526/a000136.

  PMID: 21948782 DERIVED

• Ritti-Dias RM, Wolosker N, de Moraes Forjaz CL, Carvalho CR, Cucato GG, Leao PP, de Fatima Nunes Marucci M. Strength training increases walking tolerance in intermittent claudication patients: randomized trial. J Vasc Surg. 2010 Jan;51(1):89-95. doi: 10.1016/j.jvs.2009.07.118. Epub 2009 Oct 17.

  PMID: 19837534 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Hypertension; Diabetes Mellitus; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Our sample was composed of patients with many diseases and taking different medications.

Results Point of Contact

• Title: Raphael Dias
• Organization: University of São Paulo

raphaelritti@gmail.com

55 81 9728 6878

Study Officials

• Maria FN Marucci, PhD

  University of Sao Paulo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: April 10, 2009
• Study Start: July 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 15, 2016
• Results First Posted: April 10, 2009

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)