A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult

Frailty Clinical Trial

Official title:

A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363942
• Other study ID #: 2024-5973
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 15, 2026

Study information

• Verified date: April 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Guy Hajj Boutros
• Phone: 514-501-9975
• Email: guyelhajj[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Atrophy
• Age-Related Sarcopenia
• Atrophy
• Fall Injury
• Frailty
• Old Age; Atrophy
• Sarcopenia

Intervention

Other:
• SAFE program (exercise intervention)
Participants will be asked to carry out the SAFE program with the help of a caregiver. Our healthcare professionals will visit them during the first week to explain to them and their caregivers how to perform the exercises correctly while using our website. All exercises will be performed using video capsules available on our website (https://safe-seniors.com/fr). The exercises are divided into 4 levels of difficulty: level 1 (light); level 2 (moderate); level 3 (moderate to vigorous); and level 4 (vigorous). Each level lasts 25 to 30 minutes and includes 5 exercise categories split into 5 videos: warm-up, strength, balance, flexibility, and endurance. The exercise intervention will include 3 sessions per week over 12 weeks.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital - Glen site	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Al-Aama T. Falls in the elderly: spectrum and prevention. Can Fam Physician. 2011 Jul;57(7):771-6. Erratum In: Can Fam Physician. 2014 Mar;60(3):225. — View 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. — View 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. — View Citation

Masud T, Morris RO. Epidemiology of falls. Age Ageing. 2001 Nov;30 Suppl 4:3-7. doi: 10.1093/ageing/30.suppl_4.3. No abstract available. — View 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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective 1	Number of participants that displayed changes on their functional testing (SPPB) in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.	12 weeks
Primary	Objective 2	Number of participants that displayed changes on their cognitive (STROOP) in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.	12 weeks
Secondary	Objective 4	Number of participants that displayed changes on their FES-I test in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.	12 weeks