Healthy Aging4MIITNCT05207501
Effects of Different Moderate-intensity Exercise Methods on Health in the Elderly
A study testing Exercise in people with Healthy Aging, run by University of Lausanne at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Hypoxic vs Blood Flow Restriction vs Eccentric Moderate-intensity Exercise in 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.
Read the detailed description
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.
- Conditions
- Healthy Aging
- Being tested
- Exercise
- Keywords
- Hypoxia, Blood Flow Restriction, Eccentric cycling, Exercice, Elderly
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will perform 3 times a week for 4 weeks a moderate intensity interval training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure [mmHg]
a major risk factor, when too high, for cardiovascular diseases.
Measured: 4 weeks
Baroreflex sensitivity
A measurement of the mechanism that regulates acute blood pressure changes linked to the development and progression of cardiovascular diseases
Measured: 4 weeks
Flow-mediated dilation
RHI index: a measure for arterial endothelial function
Measured: 4 weeks
Heart rate variability
An independent predictor of cardiovascular mortality and sudden cardiac death.
Measured: 4 weeks
6-Minute Cycle Test [km]
an estimation of the maximal aerobic capacity
Measured: 4 weeks
Knee flexion and extension isokinetic strength [N]
The knee flexion and extension strength will be measured with an isokinetic dynamometer
Measured: 4 weeks
Muscle mass [kg]
An analysis of muscle mass will be done using DXA scan
Measured: 4 weeks
Body fat [kg]
An analysis of body fat will be done using DXA scan
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Sep 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a randomized parallel group active-control study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregoire Millet, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207501
- Sponsor's protocol ID
- 2021-02135
- Acronym
- 4MIIT
- Status last verified
- Apr 2023
- First submitted
- 23 Dec 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxic vs Blood Flow Restriction vs Eccentric Moderate-intensity Exercise in Elderly
- ClinicalTrials.gov ID
- NCT05207501
- Acronym / sponsor ID
- 4MIIT / 2021-02135
- Conditions
- Healthy Aging
- Keywords
- Hypoxia, Blood Flow Restriction, Eccentric cycling, Exercice, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study is designed as a randomized parallel group active-control study.
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity intermittent training (MIIT) | Active comparator | Behavioral: ExerciseThe 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. |
| MIIT during intermittent hypoxic exposure (IHYP + MIIT) | Experimental | Behavioral: ExerciseA 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. |
| MIIT during intermittent blood flow restriction (IBFR + MIIT) | Experimental | Behavioral: ExerciseThe 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. |
| Moderate-intensity eccentric cycling (MIEC) | Experimental | Behavioral: ExerciseThe 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). |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will perform 3 times a week for 4 weeks a moderate intensity interval training. | Behavioural | 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) |
Primary outcome
Blood pressure [mmHg]
Time frame: 4 weeks
a major risk factor, when too high, for cardiovascular diseases.
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
Flow-mediated dilation
Time frame: 4 weeks
RHI index: a measure for arterial endothelial function
Heart rate variability
Time frame: 4 weeks
An independent predictor of cardiovascular mortality and sudden cardiac death.
6-Minute Cycle Test [km]
Time frame: 4 weeks
an estimation of the maximal aerobic capacity
Knee flexion and extension isokinetic strength [N]
Time frame: 4 weeks
The knee flexion and extension strength will be measured with an isokinetic dynamometer
Muscle mass [kg]
Time frame: 4 weeks
An analysis of muscle mass will be done using DXA scan
Body fat [kg]
Time frame: 4 weeks
An analysis of body fat will be done using DXA scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy Aging, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure [mmHg] (time frame: 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.