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OpenTrials
Completed

NCT Number: NCT05207501

Effects of Different Moderate-intensity Exercise Methods on Health in the Elderly

Aging is linked to a higher risk of cardiovascular disease. Physical exercise is recognized as an excellent strategy to prevent cardiovascular diseases and cognitive aspects, generating healthier elderly people. The beneficial effects of physical training seem to be greater when performed:

* In hypoxic conditions (i.e. when the amount of oxygen in the air is decreased as at altitude). * With intermittent blood flow restriction (by inflating pneumatic cuffs around the thighs to a pressure that restricts blood flow). This equipment is harmless. * With eccentric training (resisting against the movement of the pedal of a bicycle rather than pushing it).

The purpose of this study is then to evaluate whether moderate intensity intermittent training can induce similar or greater effects on cardiovascular health when combined with intermittent hypoxia, intermittent blood flow restriction or eccentric training.

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Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lausanne

Lausanne, Canton of Vaud, 1824, Switzerland

About this study

Aging is associated with a higher risk of cardiovascular disease due mainly to high blood pressure. Physical exercise is recognized as an excellent non-pharmacological strategy to prevent cardiovascular disease and cognitive aspects, thus generating healthier elderly people.

  • Interestingly, living at altitude seems to reduce some cardiovascular risks. In addition, the beneficial effects of physical training seem to be greater when performed under hypoxic conditions (i.e. when the amount of oxygen in the air is decreased as at altitude).
  • Another interesting strategy for the elderly is intermittent blood flow restriction. This involves inflating pneumatic cuffs around the limb(s) to a pressure that blocks or restricts blood flow to the affected muscles, alternating with rest phases. It has been found that endurance training, combined with blood flow restriction, promotes the growth of new blood vessels, which could be particularly important for the prevention of cardiovascular disease in the elderly, which is unfortunately common.
  • Eccentric training is currently emerging as a promising training strategy for the elderly. It consists of resisting the movement of the pedal of a bicycle rather than pushing it. It requires less energy effort than traditional exercise with the same workload. Eccentric training has been shown to improve older adults' body composition and muscle strength, thereby improving exercise capacity and quality of life.

These training strategies may be of interest for cardiovascular health in older adults. However, there are few data on their combined effects with exercise in the elderly and there is no consensus to favor one method over another.

The objective of this study is then to evaluate whether moderate-intensity intermittent training can induce similar or superior effects on health indicators when combined with intermittent hypoxia, partial vascular occlusion, or eccentric training.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • to be aged between 65 and 75 years old
  • not involved in regular physical activities for at least 6 months (i.e., doing no physical exercise over twice per week);
  • free of injuries as well as cardiovascular and respiratory disorders or central nervous system disease or receiving β-blocker medication;
  • not using dietary supplements, smoking or drugs which interfere with the measurements;
  • not using creatine supplementation, anabolic steroids, drugs, or medication with potential effects on physical performance;
  • to have body index mass between 20 and 30 kg/m²;
  • not to live above 800m of altitude;
  • to be vaccinated against COVID-19 and to have no symptoms (fever, cough, fatigue, loss of smell or taste);
  • able to complete all sessions;
  • able to give consent.

Treatment and study plan

Exercise

Behavioral

Participants will perform 3 times a week for 4 weeks a moderate intensity interval training.

Primary outcomes

  1. Blood pressure [mmHg]

    Time frame: 4 weeks

    a major risk factor, when too high, for cardiovascular diseases.

  2. Baroreflex sensitivity

    Time frame: 4 weeks

    A measurement of the mechanism that regulates acute blood pressure changes linked to the development and progression of cardiovascular diseases

  3. Flow-mediated dilation

    Time frame: 4 weeks

    RHI index: a measure for arterial endothelial function

  4. Heart rate variability

    Time frame: 4 weeks

    An independent predictor of cardiovascular mortality and sudden cardiac death.

  5. 6-Minute Cycle Test [km]

    Time frame: 4 weeks

    an estimation of the maximal aerobic capacity

  6. Knee flexion and extension isokinetic strength [N]

    Time frame: 4 weeks

    The knee flexion and extension strength will be measured with an isokinetic dynamometer

  7. Muscle mass [kg]

    Time frame: 4 weeks

    An analysis of muscle mass will be done using DXA scan

  8. Body fat [kg]

    Time frame: 4 weeks

    An analysis of body fat will be done using DXA scan

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Registry information

Official study title

Intermittent Hypoxic vs Blood Flow Restriction vs Eccentric Moderate-intensity Exercise in Elderly

Acronym: 4MIIT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2022
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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