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

NCT05207501 | Completed DMC

• 1 other identifier: 2021-02135
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging

Keywords

Hypoxia; Blood Flow Restriction; Eccentric cycling; Exercice; Elderly

Outcome Measures

Primary Outcomes (8)

• Blood pressure [mmHg]

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

  4 weeks

• Baroreflex sensitivity

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

  4 weeks

• Flow-mediated dilation

  RHI index: a measure for arterial endothelial function

  4 weeks

• Heart rate variability

  An independent predictor of cardiovascular mortality and sudden cardiac death.

  4 weeks

• 6-Minute Cycle Test [km]

  an estimation of the maximal aerobic capacity

  4 weeks

• Knee flexion and extension isokinetic strength [N]

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

  4 weeks

• Muscle mass [kg]

  An analysis of muscle mass will be done using DXA scan

  4 weeks

• Body fat [kg]

  An analysis of body fat will be done using DXA scan

  4 weeks

Study Arms (4)

Moderate-intensity intermittent training (MIIT)

ACTIVE COMPARATOR

The MIIT will be conducted on a cycle ergometer (Lode Ex. calibur Sport Ergometer, Lode B.V., the Netherlands) in normoxia (FiO2 = \~ 21%). The participants will perform the MIIT starting with the ergometer resistance set to obtain the %HRmax set (\~75-80%) during 5 minutes and will rest 5 minutes after each interval of exercise. The HRmax will be considered as 200 - age.

Behavioral: Exercise

MIIT during intermittent hypoxic exposure (IHYP + MIIT)

EXPERIMENTAL

A normobaric hypoxic chamber (ATS Altitude Training, Sydney, Australia) will be used for this protocol. The chamber (2.4 m x 5 m x 2.5 m) allows, via a filter and compressor system, to extract oxygen molecules and to reduce the fraction of inspired oxygen (FiO2) with no modification of the barometric pressure.

Behavioral: Exercise

MIIT during intermittent blood flow restriction (IBFR + MIIT)

EXPERIMENTAL

The IBFR + MIIT protocol will be performed while cycling in normoxia (FiO2 = \~ 21%). Elastic, pneumatic cuffs (BStrong, Park City, Utah, USA) will be administered as high as possible at the inguinal crease of the upper thigh and will be inflated during the cycling to the set pressure of 400 mmHg (except for the first training session, it will be of 250 mmHg to minimize soreness and to accustom patients to vascular occlusion training). The cuffs will be deflated at interval rest.

Behavioral: Exercise

Moderate-intensity eccentric cycling (MIEC)

EXPERIMENTAL

The MIEC will be conducted on a cycle ergometer (Excalibur, Lode, Groningen, The Nederlands) in normoxia (FiO2 = \~ 21%). The participants will be instructed to resist against the pedal movement (cadence set at 15 revolutions/min) to produce the required torque (set to obtain the 75-80%HRmax) indicated by visual feedback for 5 minutes and will rest 5 minutes after each interval of exercise. The HRmax will be considered as 200 - age. The HR responses will be monitored (Polar Electro Oy, Kempele, Finland).

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

MIIT during intermittent blood flow restriction (IBFR + MIIT); MIIT during intermittent hypoxic exposure (IHYP + MIIT); Moderate-intensity eccentric cycling (MIEC); Moderate-intensity intermittent training (MIIT)

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Lausanne: lead

Study Sites (1)

University of Lausanne

Lausanne, Canton of Vaud, 1824, Switzerland

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The active-control group will receives a comparable standard treatment to the three other groups: Moderate Intensity Interval Training on a ergocycle without any additional feature.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is designed as a randomized parallel group active-control study.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 26, 2022
• Study Start: September 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)