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
Results First Received: January 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Peripheral Arterial Disease
Hypertension
Diabetes
Interventions: Behavioral: Walking Training Program
Behavioral: Strength Training Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 (min) at 2 miles per hour (mph), were invited to a meeting at which explanations about this study were given.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven patients did not present symptoms of claudication during the treadmill test, 5 presented electrocardiogram response suggestive of myocardial ischemia, 4 presented exercise tolerance limited by other factors than claudication, and 2 presented poorly controlled blood pressure. All these patients were not included in the study.

Reporting Groups
  Description
Strength Training Patients who performed strength training. 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-minutes interval between sets and exercises.
Walking Training Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes 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.

Participant Flow:   Overall Study
    Strength Training     Walking Training  
STARTED     17 [1]   17 [1]
COMPLETED     15 [2]   15 [2]
NOT COMPLETED     2     2  
Physician Decision                 2                 2  
[1] Seventeen patients achieved inclusion and exclusion criteria
[2] Two patients did not finish the trial



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Strength Training Patients who performed strength training. 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-minutes interval between sets and exercises.
Walking Training Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes 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.
Total Total of all reporting groups

Baseline Measures
    Strength Training     Walking Training     Total  
Number of Participants  
[units: participants]
  17     17     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     3     7  
>=65 years     13     14     27  
Age  
[units: years]
Mean ± Standard Deviation
  65.7  ± 9.5     64.6  ± 8.8     65.1  ± 9.3  
Gender  
[units: participants]
     
Female     5     7     12  
Male     12     10     22  
Region of Enrollment  
[units: participants]
     
Brazil     17     17     34  
Total walking distance [1]
[units: meter]
Mean ± Standard Deviation
  618  ± 282     572  ± 231     595  ± 244  
[1] The maximal walking capacity of patients



  Outcome Measures

1.  Primary:   Total Walking Distance   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our sample was composed of patients with many diseases and taking different medications.  


Results Point of Contact:  
Name/Title: Raphael Dias
Organization: University of São Paulo
phone: 55 81 9728 6878
e-mail: raphaelritti@gmail.com


Publications of Results:
Publications automatically indexed to this study:

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