Clinical trial NCT06363942: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult
Official title: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall Injury
Frailty
Old Age; Atrophy
Age-Related Atrophy
Age-Related Sarcopenia
Keywords: frailty
exercise
older adult
ageing
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

Detailed description: For this study, the investigators will recruit 100 frail men and women aged 75 and over from the greater Montreal area. Enrolled participants will have 4 visits at their residence. The first visit, is a screening visit, the second is a pre-intervention assessment of cognition and functional abilities and explanation of the exercise program. The third visit will be a virtual visit, by phone call, and the final visit will be a post-intervention assessment of cognition and functional abilities.

Participants in the experimental group will engage in the SAFE exercises three times a week for 12 weeks at home while continuing their activities of daily living (ADLs) without any changes. Participants in the control group will not engage in the SAFE exercises but will be asked to maintain their ADLs without any changes. Before and after the 12-week intervention, all participants will complete a comprehensive battery of assessments to evaluate changes in their muscular strength, functional capacities, cognitive abilities and quality of life. At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

Eligibility criteria: Inclusion Criteria:

* Considered Frail or Pre frail according to Fried's criteria

Exclusion Criteria:

* Smoked within 6 months prior to study enrollment,
* dementia diagnosos,
* Abused drugs, medication or alcohol within up to 30 days prior to the start of the study.
* drug or alcohol-addiction,
* Heart disease, history of heart attacks or electrocardiogram abnormalities
* Any family history of thrombosis, thrombosis risk,
* hypocalcaemia,
* uric acidemia,
* orthostatic intolerance,
* vestibular disorders,
* considerable musculoskeletal issues,
* chronic back pain,
* head trauma,
* seizures,
* ulcers,
* renal stones,
* gastro-esophageal reflux disease,
* renal function disorder,
* hiatus hernia,
* migraines,
* mental illness diagnosis
* prescribed medication that may interfere with the interpretation of the results

Primary outcomes:
measure: Objective 1
timeFrame: 12 weeks
measure: Objective 2
timeFrame: 12 weeks
Secondary outcomes:
measure: Objective 4
timeFrame: 12 weeks
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 Health Centre
name: Jose Morais, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.
citation: Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.
citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
citation: Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
citation: Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. doi: 10.1016/S0887-6177(03)00039-8.
citation: Jensen AR, Rohwer WD Jr. The Stroop color-word test: a review. Acta Psychol (Amst). 1966;25(1):36-93. doi: 10.1016/0001-6918(66)90004-7. No abstract available.