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

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes; Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Strength Training; Behavioral: Walking Training

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05588000
    • Raphael Dias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; 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.; Other Names: Walk training; Walk exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Walking Distance	The maximal walking distance	12 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Chair: Maria FN Marucci, PhD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 27, 2009
• First Submitted That Met QC Criteria: March 9, 2009
• First Posted (Estimate): April 10, 2009

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: exercise; resistance training; peripheral arterial disease; cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 44444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No