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Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients

U

University Medical Centre Ljubljana

Status

Unknown

Conditions

Coronary Artery Disease
Coronary Disease

Treatments

Other: Resistance training with vascular occlusion

Study type

Interventional

Funder types

Other

Identifiers

NCT03087292
UKCLRehab022017

Details and patient eligibility

About

In our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group).

Full description

Physical activity in patients with coronary heart disease improves health, quality of life, and reduces risk of coronary events, morbidity and mortality. Aerobic training is preferred as a part of cardiac rehabilitation with its well established evidence-based guidelines. On the other hand, the resistance training was first introduced as a part of cardiac rehabilitation just over a decade ago, due to its positive effects on performance, quality of life and muscle hypertrophy and strength. Despite the positive effects of resistance training, there still lacks evidence about its effect on cardiovascular health. Furthermore, guidelines still do not specify the exact training volumes, doses and types of resistance training for patients with coronary heart disease.

In clinical practice, it is often difficult and contraindicated to use near-maximal loads (e.g., in the early stages of cardiac rehabilitation, after sport injury, etc.). Muscle atrophy and weakness often occur rapidly in the affected area due to the effects of trauma (or disease) and inactivity. Consequently, training modalities that promote hypertrophy or counteract atrophy without the use of heavy loads should be of special interest in the rehabilitation of some chronic diseases for which high musculoskeletal forces are contraindicated.

Occlusive strength training with tourniquet cuffs was first used nearly twenty years ago. Studies have shown that low to-moderate intensity (20-50% of 1RM) resistance training with vascular occlusion leads to gains in muscle strength and volume comparable to those seen after conventional heavy resistance training. This effects suggest, that ischemic strength training may be a useful method in rehabilitation and other contexts.

To conclude, the aim of this study is to compare the effect of low intensity resistance training with vascular occlusion vs. normal physical activity on:

  1. muscle hypertrophy, strength and neuromuscular parameters;
  2. vascular function;
  3. and blood parameters (anabolic and catabolic hormones, catecholamines, inflammations factors, parameters of oxidative stress etc.)

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • above 18 years old and below 75 years old
  • coronary heart disease documented with clinical event
  • stable coronary heart disease patients

Exclusion criteria

  • Unstable phase of coronary heart disease
  • dysfunction of left ventricle
  • residual myocardial ischemia
  • contraindications for physical activity,
  • intellectual development disorder,
  • recent dissection of aorta
  • recent vein thrombolysis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Resistance training group
Active Comparator group
Description:
Patients to be randomly assigned to the "resistance training group" will have resistance training with vascular occlusion 2 times per week for a period of 8 weeks on unilateral leg extension machine. During each training, they will performed 3 sets of 15 repetitions at the intensity of 30% 1 RM (repetition maximum). Each training set will separated by a 30 second rest period.
Treatment:
Other: Resistance training with vascular occlusion
Control group
No Intervention group
Description:
Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime.

Trial contacts and locations

1

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Central trial contact

Tim Kambič, BSc; Borut Jug, PhD, MD

Data sourced from clinicaltrials.gov

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