Treadmill Exercise and Resistance Training in Patients With Peripheral Arterial Disease With and Without Intermittent Claudication - Treadmill Exercise and Resistance Training in Patients With Peripheral Arterial Disease With and Without Intermittent Claudication

Jan 13, 2009
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Heart, Lung, and Blood Institute and the National Center for Research Resources, National Institutes of Health
Date Published:
01/01/2009
Date Updated:
01/13/2009
Original Posted Date:
01/13/2009
References

Description:

The goal of the trial was to evaluate: 1) an exercise treadmill program, 2) a strength training program, or 3) control in patients with peripheral arterial disease (with or without claudication).

Hypothesis:

Treadmill exercise or strength training will be more effective in improving functional performance in patients with claudication.

Study Design

  • Randomized
  • Parallel

Patients Screened: 1,009
Patients Enrolled: 156
Mean Follow Up: 6 months
Mean Patient Age: 71.7 years
Female: 53%

Patient Populations:

  • Patients with peripheral arterial disease, defined as an ankle brachial index of 0.95 or lower

Exclusions:

  • Dementia
  • Critical limb ischemia
  • Foot ulcers
  • Major amputation
  • Nursing home residence
  • Inability to walk on a treadmill or exercise 3 times per week
  • Failure to complete exercise run-in sessions
  • Major surgery or myocardial infarction within the past 3 months
  • Major surgery planned within the upcoming year
  • Current participation in another clinical trial
  • Baseline exercise similar with that offered in either exercise group
  • Abnormal baseline exercise stress test
  • Walking limitation from an etiology other than peripheral arterial disease
  • Poorly controlled hypertension
  • Baseline short physical performance battery score of 12

Primary Endpoints:

  • 6-minute walk performance
  • Short physical performance battery

Secondary Endpoints:

  • Brachial artery flow-mediated dilatation
  • Treadmill walking performance
  • Walking Impairment Questionnaire
  • 36-Item Short Form Health Survey physical functioning score

Drug/Procedures Used:

Patients with peripheral arterial disease (with or without claudication) were randomized to one of three groups: supervised treadmill exercise (n = 51), supervised lower extremity resistance training (n = 52), or control (n = 53).

Principal Findings:

Overall, 156 patients were randomized. There was no difference in baseline characteristics between the groups. In the treadmill walking group, the mean age was 71.7 years, 52.9% were women, 23.5% reported claudication, and the mean ankle brachial index was 0.60. The baseline 6-minute walk performance was 328 m in the treadmill walking group, 305 m in the strength training group, and 317 m in the control group.

At 6 months, the difference in the 6-minute walk performance was 20.9 m with treadmill walking (p < 0.001), -2.60 m with strength training (p = 0.24), and -15.02 m with control.

The change in short physical performance battery was 0.34 (p = 0.58), 0.54 (p > 0.99), and 0.54, respectively. Relative change in brachial artery flow-mediated dilation was 0.70% (p = 0.02), 0.11% (p = 0.23), and -0.86%, respectively. The change in physical activity units was 122 (p = 0.37), -49.03 (p = 0.82), and -12.85, respectively. The change in the walking impairment questionnaire distance score was 9.94 (p = 0.02), 8.52 (p = 0.03), and 0.25, respectively.

Interpretation:

Among patients with claudication, treadmill exercise training improves 6-minute walk performance, brachial artery flow-mediated dilation, and quality of life. Strength training did not improve 6-minute walk performance, although it did improve quality of life. Exercise treadmill training represents a relatively safe means of improving 6-minute walk performance and quality of life, and should be recommended to patients with peripheral arterial disease with and without claudication who are able to exercise. Further research is needed to determine if the improvement in brachial artery flow-mediated dilation (i.e., improvement in endothelial function) will improve clinical events.

References:

McDermott MM, Ades P, Guralnik JM, et al. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA 2009;301:165-74.

Keywords: Resistance Training, Intermittent Claudication, Walking, Pyridinolcarbamate, Quality of Life, Ankle Brachial Index, Peripheral Arterial Disease, Surveys and Questionnaires, Lower Extremity, Peripheral Vascular Diseases, Exercise Test


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