Clinical trial NCT04964999: Understanding the Negative Effects of Bed Rest and Using Exercise as Countermeasure
Official title: Microgravity Research Analogue (MRA): Understanding the Health Impact of Inactivity for the Benefit of Older Adults and Astronauts Initiative
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: Bed rest
Exercise
Aging
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Space Agency
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Frailty Network
First posted: 2021-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study - Participants will be randomly allocated to the exercise or control group.
Primary purpose: BASIC_SCIENCE

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Changes in cognition status of participants with head down bed rest (HDBR) with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in cognition status of participants with head down bed rest (HDBR) with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in emotional status of participants with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in emotional status of participants with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in brain structure with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in brain function with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in muscle muscle mass with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in muscle fat infiltration with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in adiposity with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in ventricular volume of the heart with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in ventricular mass with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in bone structure with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in muscle strength with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in muscle strength with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in muscle-pump baroreflex with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in balance control with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in orthostatic tolerance with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Cardiac and vascular changes with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Cardiac and vascular changes with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Cardiac and vascular changes with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Cardiac and vascular changes with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in Fractional Synthesis Rate (FSR) with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: during HDBR period
measure: Changes in sleep quality with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in sleep architecture with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in frailty status with HDBR with and without exercise countermeasure.
timeFrame: Throughput the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in the gut microbiome with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in the constitution of the oral microbiome with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in physical performance with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in physical performance with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in dynamic balance with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in bone markers with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in growth factors with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in cytokines with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
Secondary outcomes:
measure: Changes in neuromotor function with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in aerobic capacity with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in body composition with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline and Recovery periods
measure: Changes in insulin sensitivity with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
measure: Changes in neuronal factors with HDBR with and without exercise countermeasure.
timeFrame: Throughout the 26-day study period: at Baseline, HDBR and Recovery periods
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Royal Victoria Hospital - Glen site
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University
name: José A. Morais, MD
role: PRINCIPAL_INVESTIGATOR
References: