AgingNCT04964999
Understanding the Negative Effects of Bed Rest and Using Exercise as Countermeasure
A study testing Exercise in people with Aging, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Physical activity appears to be an important lifestyle habit to achieve healthy aging by promoting autonomy and quality of life. Interestingly, the dramatic changes that the human body undergoes due to bedrest for illnesses and hospitalization are similar to those seen over decades of normal aging. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2021to Apr 2022
- 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A minimum of 20 and a maximum of 24 non-smoking participants in the age group of 55 to 65 years old, half male and half female.
- Female participants must be menopausal (no menses for at least 1 year (or documented ovariectomy) and a serum FSH above 30 IU/L).
- Height between 158 to 190 cm with a body mass index between 20 to 30 kg/m2.
- Physically and mentally healthy subjects that will have successfully passed the psychological and medical screening appropriate for the age group.
- Participation in at least 2.5 hours of exercise at a moderate to vigorous-intensity aerobic activity per week.
- Willing to be assigned randomly either to the exercise or the control group.
Who cannot join
- Participants must be dementia-free, drug- or alcohol-addiction free, with no history of heart attacks, no thrombosis risk, no severe allergies, no hypocalcaemia, no uric acidemia, no orthostatic intolerance, no vestibular disorders, no considerable musculoskeletal issues, no chronic back pain, no head trauma, no seizures, no ulcers, no renal stones, no gastro-esophageal reflux disease or renal function disorder, no hiatus hernia, no migraines, and no mental illness.
- Electrocardiogram abnormalities
- Anemia
- Low bone mineral density
- Medication requirements that may interfere with the interpretation of the results
- Recent substandard nutritional status
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- Claustrophobia
- Special dietary requests (e.g. vegetarian, vegan or some other diet)
- Sedentary people and people that are addicted to exercise
- Metallic implants (pacemakers, ICDs, CRT devices, infusion pumps, cerebral artery aneurysm clips, dental implants, tissue expander etc.), osteosynthesis material
- Given blood in the past 3 months before the onset of the experiment
- Smoked (tobacco and/or marijuana (THC)) within 6 months prior to the start of the study
- Abused drugs, medicine or alcohol within up to 30 days prior to the start of the study
- Participated in another study within 2 months before study onset
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital - Glen site
Montreal, Quebec, H4A 3J1
Guy Hajj Boutros, 514-8934-1934 ext. 35016, guyelhajj@gmail.com
About this study
Official title: Microgravity Research Analogue (MRA): Understanding the Health Impact of Inactivity for the Benefit of Older Adults and Astronauts Initiative
Physical activity appears to be an important lifestyle habit to achieve healthy aging by promoting autonomy and quality of life. Interestingly, the dramatic changes that the human body undergoes due to bedrest for illnesses and hospitalization are similar to those seen over decades of normal aging. Bedrest in otherwise healthy older individuals can lead to a reduction of muscle size and strength, changes in bone strength and function of the heart and blood vessels. Bedrest can also lead to changes in keeping proper balance as well as changes in processing and understanding information. All of these factors negatively affect activities of daily living leading to physical function impairment and development of frailty, a clinical condition associated with an increased risk for disease and death.
The purpose of this study is to investigate whether exercise can counteract the negative effects of 2-week head tilt down bed rest on muscle function and metabolism, postural control, bone structure, orthostatic tolerance and cognitive function in adults.
Read more
For this study the investigators will recruit 24 healthy men and women between 55 - 65 years of age. All subjects will spend a total of 26 days (5 days of adaption period, 14 days of bed rest with 6 degrees of downward inclination, and 7 days of recovery period) at the McGill University Health Centre (MUHC). During this study, 12 subjects will randomly undergo an exercise intervention as countermeasure during the 14 days of bed rest period and 12 will serve as control.
Each subjects participation in this study will involve 1 telephone call (pre-screening) and 4 visits at the MUHC: 1 screening visit (Visit 1) followed by a 26-day long visit (Visit 2) and 2 follow-up visits (Visit 3 and Visit 4). During Visits 2 - 4 various measurements will be performed to assess sensorimotor control, muscle function and metabolism, bone structure, cardiovascular function, cognitive performance and function, and specimen collection (blood, urine, saliva, feces and muscle tissue).
- Conditions
- Aging
- Being tested
- Exercise
- Keywords
- Bed rest, Exercise, Aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants will undergo an exercise program during the 2-week bed rest period.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will perform aerobic and strength exercises for 2 weeks. Receives: Other: Exercise |
| No exercise | No intervention | Participants will not perform any exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognition status of participants with head down bed rest (HDBR) with and without exercise countermeasure.
NIH Toolbox Cognition Battery (computerized)
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in cognition status of participants with head down bed rest (HDBR) with and without exercise countermeasure.
CLSA cognition questionnaire
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in emotional status of participants with HDBR with and without exercise countermeasure.
Positive and Negative Affect Scale
- For both scales scores can range from 10-50, with higher scores representing higher levels of positive or negative affect.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in emotional status of participants with HDBR with and without exercise countermeasure.
General Health Questionnaire (GHQ-28).
- Using Likert 4-point scale with the min score being 0 and max score being 84.
- Higher scores indicate a higher level of distress.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in brain structure with HDBR with and without exercise countermeasure.
Assessment of brain anatomy using a MRI.
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in brain function with HDBR with and without exercise countermeasure.
Measurement of neuronal, cerebrovascular, and connectivity integrity with functional MRI.
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in muscle muscle mass with HDBR with and without exercise countermeasure.
Body MRI
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in muscle fat infiltration with HDBR with and without exercise countermeasure.
Body MRI
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in adiposity with HDBR with and without exercise countermeasure.
Body MRI
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in ventricular volume of the heart with HDBR with and without exercise countermeasure.
Using a heart MRI left and right ventricular volumes will be assessed.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in ventricular mass with HDBR with and without exercise countermeasure.
Using a heart MRI left and right ventricular mass will be assessed.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in bone structure with HDBR with and without exercise countermeasure.
High resolution peripheral quantitative computed tomography (HR-pQCT)
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in muscle strength with HDBR with and without exercise countermeasure.
Quantitative Muscle Dynamometry (Biodex)
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in muscle strength with HDBR with and without exercise countermeasure.
Vertical jump
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in muscle-pump baroreflex with HDBR with and without exercise countermeasure.
Supine-to-stand test
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in balance control with HDBR with and without exercise countermeasure.
Postural equilibrium control test
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in orthostatic tolerance with HDBR with and without exercise countermeasure.
Tilt test
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Using high frame rate ultrasound (HiFRUS) arterial wall shear stress will be assessed.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Using high frame rate ultrasound (HiFRUS) arterial wall stiffness will be assessed.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Using high frame rate ultrasound (HiFRUS) cardiac mass will be assessed.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Using high frame rate ultrasound (HiFRUS) patterns of blood flow will be assessed.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in Fractional Synthesis Rate (FSR) with HDBR with and without exercise countermeasure.
Measurement of protein turnover.
Measured: Throughout the 26-day study period: during HDBR period
Changes in sleep quality with HDBR with and without exercise countermeasure.
Sleep quality will be assessed using a 3-electrode electroencephalogram (EEG) Sleep Profiler and a wrist worn actigraphy.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in sleep architecture with HDBR with and without exercise countermeasure.
Using 3-electrode electroencephalogram (EEG) Sleep Profiler electrical patterns of brain activity will be measured in order to assess sleep cycles and sleep stages.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in frailty status with HDBR with and without exercise countermeasure.
CLSA-FI questionnaire
Measured: Throughput the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in the gut microbiome with HDBR with and without exercise countermeasure.
To assess gut microbiome, stool samples will be collected and targeted sequencing of the variable regions 4 and 5 (V4-V5) of the 16S ribosomal RNA gene will be performed on an Illumina MiSeq.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in the constitution of the oral microbiome with HDBR with and without exercise countermeasure.
To assess oral microbiome, saliva samples will be collected and targeted sequencing of the variable regions 4 and 5 (V4-V5) of the 16S ribosomal RNA gene will be performed on an Illumina MiSeq.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in physical performance with HDBR with and without exercise countermeasure.
Short Physical Performance Battery test
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in physical performance with HDBR with and without exercise countermeasure.
Timed-up-and-Go test
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in dynamic balance with HDBR with and without exercise countermeasure.
Four-square step test
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in bone markers with HDBR with and without exercise countermeasure.
The following bone markers will be assessed using ELISA kits:
- Total osteocalcin
- Undercarboxylated osteocalcin
- Sclerostin
- NTX (N-terminal Telopeptide)
- CTX (C-terminal telopeptide)
- Bone Specific Alkaline Phosphatase (BSAP)
- Procollagen type 1 amino-terminal propeptide (P1NP)
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in growth factors with HDBR with and without exercise countermeasure.
The following growth factors will be measured with Multiplex:
- Basic fibroblast growth factor
- Granulocyte colony-stimulating factor (G-CSF)
- Granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Platelet-derived growth factor BB (PDGF-BB)
- Transforming growth factor β (TGF-β)
- Vascular endothelial growth factor (VEGF)
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in cytokines with HDBR with and without exercise countermeasure.
The following cytokines will be measured with Multiplex:
- Eotaxin
- Interferon gamma (IFN-γ)
- IL-1β, IL-1Ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17
- Tumour necrosis factor (TNF-α)
- Interferon gamma- induced protein 10 (IP-10)
- Monocyte chemoattractant protein 1 (MCP-1)
- Macrophage inflammatory protein-1α (MIP-1α)
- Macrophage inflammatory protein-1β (MIP-1β)
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Secondary outcomes (5)
Changes in neuromotor function with HDBR with and without exercise countermeasure.
Neuromuscular activity will be assessed using electromyography.
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in aerobic capacity with HDBR with and without exercise countermeasure.
Bicycle Ergometer Test
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in body composition with HDBR with and without exercise countermeasure.
Lean muscle and fat mass will be assess using dual energy X-ray absorptiometry.
Measured: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in insulin sensitivity with HDBR with and without exercise countermeasure.
Will measure excursion curves of glucose and insulin.
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in neuronal factors with HDBR with and without exercise countermeasure.
The following bone markers will be assessed using ELISA kits:
- Neurofilament light chain
- Glial fibrillary acidic protein
- Myelin basic protein
- Total tau
- Aβ1-40
- Aβ1-42
- BDNF
Measured: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start12 Jul 2021
- Primary completionFeb 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study - Participants will be randomly allocated to the exercise or control group.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Space Agency, Canadian Institutes of Health Research (CIHR), Canadian Frailty Network
- Responsible party
- Principal investigator, Jose Morais, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- José A. Morais, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964999
- Sponsor's protocol ID
- MP-37-2021-7170
- Status last verified
- Sep 2021
- First submitted
- 6 May 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Law NY, Ahmed Yahia K, Gill-Lussier J, Falaki A, Tonkov H, Abbariki F, Faust A, Morais JA, Hajj-Boutros G, Barthelemy D. The impact of 14-day head-down bed rest with or without an exercise countermeasure on standing balance control: a randomized controlled trial. NPJ Microgravity. 2026 Jun 26. doi: 10.1038/s41526-026-00624-x. Online ahead of print.
PubMed 42362567Mastrandrea CJ, Hajj-Boutros G, Sonjak V, Hedge ET, Gouspillou G, Hughson RL, Morais JA. Exercise attenuates bed rest-induced increases in insulin resistance while alpha-klotho increases in 55 to 65 year-old women and men. Sci Rep. 2025 Jul 24;15(1):26927. doi: 10.1038/s41598-025-12770-5.
PubMed 40707556Balbim GM, Falck RS, Barha CK, Tai D, Best JR, Hajj-Boutros G, Madden K, Liu-Ambrose T. Exercise counters the negative impact of bed rest on executive functions in middle-aged and older adults: A proof-of-concept randomized controlled trial. Maturitas. 2023 Oct 17;179:107869. doi: 10.1016/j.maturitas.2023.107869. Online ahead of print.
PubMed 39491057Dulac M, Hajj-Boutros G, Sonjak V, Faust A, Hussain SNA, Chevalier S, Dionne IJ, Morais JA, Gouspillou G. A multimodal exercise countermeasure prevents the negative impact of head-down tilt bed rest on muscle volume and mitochondrial health in older adults. J Physiol. 2025 Jul;603(13):3813-3836. doi: 10.1113/JP285897. Epub 2024 Jun 15.
PubMed 38878232Hajj-Boutros G, Sonjak V, Faust A, Balram S, Lagace JC, St-Martin P, Divsalar DN, Sadeghian F, Liu-Ambrose T, Blaber AP, Dionne IJ, Duchesne S, Kontulainen S, Theou O, Morais JA. Myths and Methodologies: Understanding the health impact of head down bedrest for the benefit of older adults and astronauts. Study protocol of the Canadian Bedrest Study. Exp Physiol. 2024 May;109(5):812-827. doi: 10.1113/EP091473. Epub 2024 Feb 19.
PubMed 38372420Blaber AP, Sadeghian F, Naz Divsalar D, Scarisbrick IA. Elevated biomarkers of neural injury in older adults following head-down bed rest: links to cardio-postural deconditioning with spaceflight and aging. Front Hum Neurosci. 2023 Sep 26;17:1208273. doi: 10.3389/fnhum.2023.1208273. eCollection 2023.
PubMed 37822710
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microgravity Research Analogue (MRA): Understanding the Health Impact of Inactivity for the Benefit of Older Adults and Astronauts Initiative
- ClinicalTrials.gov ID
- NCT04964999
- Acronym / sponsor ID
- MP-37-2021-7170
- Conditions
- Aging
- Keywords
- Bed rest, Exercise, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Space Agency, Canadian Institutes of Health Research (CIHR), Canadian Frailty Network
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 Jul 2021 (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.
Physical activity appears to be an important lifestyle habit to achieve healthy aging by promoting autonomy and quality of life. Interestingly, the dramatic changes that the human body undergoes due to bedrest for illnesses and hospitalization are similar to those seen over decades of normal aging. Bedrest in otherwise healthy older individuals can lead to a reduction of muscle size and strength, changes in bone strength and function of the heart and blood vessels. Bedrest can also lead to changes in keeping proper balance as well as changes in processing and understanding information. All of these factors negatively affect activities of daily living leading to physical function impairment and development of frailty, a clinical condition associated with an increased risk for disease and death.
The purpose of this study is to investigate whether exercise can counteract the negative effects of 2-week head tilt down bed rest on muscle function and metabolism, postural control, bone structure, orthostatic tolerance and cognitive function in adults.
For this study the investigators will recruit 24 healthy men and women between 55 - 65 years of age. All subjects will spend a total of 26 days (5 days of adaption period, 14 days of bed rest with 6 degrees of downward inclination, and 7 days of recovery period) at the McGill University Health Centre (MUHC). During this study, 12 subjects will randomly undergo an exercise intervention as countermeasure during the 14 days of bed rest period and 12 will serve as control.
Each subjects participation in this study will involve 1 telephone call (pre-screening) and 4 visits at the MUHC: 1 screening visit (Visit 1) followed by a 26-day long visit (Visit 2) and 2 follow-up visits (Visit 3 and Visit 4). During Visits 2 - 4 various measurements will be performed to assess sensorimotor control, muscle function and metabolism, bone structure, cardiovascular function, cognitive performance and function, and specimen collection (blood, urine, saliva, feces and muscle tissue).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study - Participants will be randomly allocated to the exercise or control group.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipants will perform aerobic and strength exercises for 2 weeks. |
| No exercise | No intervention | –Participants will not perform any exercises. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A minimum of 20 and a maximum of 24 non-smoking participants in the age group of 55 to 65 years old, half male and half female.
- Female participants must be menopausal (no menses for at least 1 year (or documented ovariectomy) and a serum FSH above 30 IU/L).
- Height between 158 to 190 cm with a body mass index between 20 to 30 kg/m2.
- Physically and mentally healthy subjects that will have successfully passed the psychological and medical screening appropriate for the age group.
- Participation in at least 2.5 hours of exercise at a moderate to vigorous-intensity aerobic activity per week.
Key exclusion criteria (14 listed)
- Participants must be dementia-free, drug- or alcohol-addiction free, with no history of heart attacks, no thrombosis risk, no severe allergies, no hypocalcaemia, no uric acidemia, no orthostatic intolerance, no vestibular disorders, no considerable musculoskeletal issues, no chronic back pain, no head trauma, no seizures, no ulcers, no renal stones, no gastro-esophageal reflux disease or renal function disorder, no hiatus hernia, no migraines, and no mental illness.
- Electrocardiogram abnormalities
- Anemia
- Low bone mineral density
- Medication requirements that may interfere with the interpretation of the results
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 undergo an exercise program during the 2-week bed rest period. | Other | Exercise |
Primary outcome
Changes in cognition status of participants with head down bed rest (HDBR) with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
NIH Toolbox Cognition Battery (computerized)
Changes in cognition status of participants with head down bed rest (HDBR) with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
CLSA cognition questionnaire
Changes in emotional status of participants with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Positive and Negative Affect Scale - For both scales scores can range from 10-50, with higher scores representing higher levels of positive or negative affect.
Changes in emotional status of participants with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
General Health Questionnaire (GHQ-28). * Using Likert 4-point scale with the min score being 0 and max score being 84. * Higher scores indicate a higher level of distress.
Changes in brain structure with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Assessment of brain anatomy using a MRI.
Changes in brain function with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Measurement of neuronal, cerebrovascular, and connectivity integrity with functional MRI.
Changes in muscle muscle mass with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Body MRI
Changes in muscle fat infiltration with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Body MRI
Changes in adiposity with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Body MRI
Changes in ventricular volume of the heart with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Using a heart MRI left and right ventricular volumes will be assessed.
Changes in ventricular mass with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Using a heart MRI left and right ventricular mass will be assessed.
Changes in bone structure with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
High resolution peripheral quantitative computed tomography (HR-pQCT)
Changes in muscle strength with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Quantitative Muscle Dynamometry (Biodex)
Changes in muscle strength with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Vertical jump
Changes in muscle-pump baroreflex with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Supine-to-stand test
Changes in balance control with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Postural equilibrium control test
Changes in orthostatic tolerance with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Tilt test
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Using high frame rate ultrasound (HiFRUS) arterial wall shear stress will be assessed.
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Using high frame rate ultrasound (HiFRUS) arterial wall stiffness will be assessed.
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Using high frame rate ultrasound (HiFRUS) cardiac mass will be assessed.
Cardiac and vascular changes with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Using high frame rate ultrasound (HiFRUS) patterns of blood flow will be assessed.
Changes in Fractional Synthesis Rate (FSR) with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: during HDBR period
Measurement of protein turnover.
Changes in sleep quality with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Sleep quality will be assessed using a 3-electrode electroencephalogram (EEG) Sleep Profiler and a wrist worn actigraphy.
Changes in sleep architecture with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Using 3-electrode electroencephalogram (EEG) Sleep Profiler electrical patterns of brain activity will be measured in order to assess sleep cycles and sleep stages.
Changes in frailty status with HDBR with and without exercise countermeasure.
Time frame: Throughput the 26-day study period: at Baseline, HDBR and Recovery periods
CLSA-FI questionnaire
Changes in the gut microbiome with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
To assess gut microbiome, stool samples will be collected and targeted sequencing of the variable regions 4 and 5 (V4-V5) of the 16S ribosomal RNA gene will be performed on an Illumina MiSeq.
Changes in the constitution of the oral microbiome with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
To assess oral microbiome, saliva samples will be collected and targeted sequencing of the variable regions 4 and 5 (V4-V5) of the 16S ribosomal RNA gene will be performed on an Illumina MiSeq.
Changes in physical performance with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Short Physical Performance Battery test
Changes in physical performance with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Timed-up-and-Go test
Changes in dynamic balance with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Four-square step test
Changes in bone markers with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
The following bone markers will be assessed using ELISA kits: * Total osteocalcin * Undercarboxylated osteocalcin * Sclerostin * NTX (N-terminal Telopeptide) * CTX (C-terminal telopeptide) * Bone Specific Alkaline Phosphatase (BSAP) * Procollagen type 1 amino-terminal propeptide (P1NP)
Changes in growth factors with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
The following growth factors will be measured with Multiplex: * Basic fibroblast growth factor * Granulocyte colony-stimulating factor (G-CSF) * Granulocyte-macrophage colony-stimulating factor (GM-CSF) * Platelet-derived growth factor BB (PDGF-BB) * Transforming growth factor β (TGF-β) * Vascular endothelial growth factor (VEGF)
Changes in cytokines with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
The following cytokines will be measured with Multiplex: * Eotaxin * Interferon gamma (IFN-γ) * IL-1β, IL-1Ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17 * Tumour necrosis factor (TNF-α) * Interferon gamma- induced protein 10 (IP-10) * Monocyte chemoattractant protein 1 (MCP-1) * Macrophage inflammatory protein-1α (MIP-1α) * Macrophage inflammatory protein-1β (MIP-1β)
5 secondary outcomes
Changes in neuromotor function with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in aerobic capacity with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in body composition with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline and Recovery periods
Changes in insulin sensitivity with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Changes in neuronal factors with HDBR with and without exercise countermeasure.
Time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 42362567Law NY, Ahmed Yahia K, Gill-Lussier J, Falaki A, Tonkov H, Abbariki F, Faust A, Morais JA, Hajj-Boutros G, Barthelemy D. The impact of 14-day head-down bed rest with or without an exercise countermeasure on standing balance control: a randomized controlled trial. NPJ Microgravity. 2026 Jun 26. doi: 10.1038/s41526-026-00624-x. Online ahead of print.
- Derived from this study: PubMed 40707556Mastrandrea CJ, Hajj-Boutros G, Sonjak V, Hedge ET, Gouspillou G, Hughson RL, Morais JA. Exercise attenuates bed rest-induced increases in insulin resistance while alpha-klotho increases in 55 to 65 year-old women and men. Sci Rep. 2025 Jul 24;15(1):26927. doi: 10.1038/s41598-025-12770-5.
- Derived from this study: PubMed 39491057Balbim GM, Falck RS, Barha CK, Tai D, Best JR, Hajj-Boutros G, Madden K, Liu-Ambrose T. Exercise counters the negative impact of bed rest on executive functions in middle-aged and older adults: A proof-of-concept randomized controlled trial. Maturitas. 2023 Oct 17;179:107869. doi: 10.1016/j.maturitas.2023.107869. Online ahead of print.
- Derived from this study: PubMed 38878232Dulac M, Hajj-Boutros G, Sonjak V, Faust A, Hussain SNA, Chevalier S, Dionne IJ, Morais JA, Gouspillou G. A multimodal exercise countermeasure prevents the negative impact of head-down tilt bed rest on muscle volume and mitochondrial health in older adults. J Physiol. 2025 Jul;603(13):3813-3836. doi: 10.1113/JP285897. Epub 2024 Jun 15.
- Derived from this study: PubMed 38372420Hajj-Boutros G, Sonjak V, Faust A, Balram S, Lagace JC, St-Martin P, Divsalar DN, Sadeghian F, Liu-Ambrose T, Blaber AP, Dionne IJ, Duchesne S, Kontulainen S, Theou O, Morais JA. Myths and Methodologies: Understanding the health impact of head down bedrest for the benefit of older adults and astronauts. Study protocol of the Canadian Bedrest Study. Exp Physiol. 2024 May;109(5):812-827. doi: 10.1113/EP091473. Epub 2024 Feb 19.
- Derived from this study: PubMed 37822710Blaber AP, Sadeghian F, Naz Divsalar D, Scarisbrick IA. Elevated biomarkers of neural injury in older adults following head-down bed rest: links to cardio-postural deconditioning with spaceflight and aging. Front Hum Neurosci. 2023 Sep 26;17:1208273. doi: 10.3389/fnhum.2023.1208273. eCollection 2023.
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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.
José A. Morais, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University
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 Aging, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Hajj Boutros (514-934-1934 ext. 35016, guyelhajj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognition status of participants with head down bed rest (HDBR) with and without exercise countermeasure. (time frame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04964999, which also lists 6 linked publications.
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 5 Sep 2021.