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

NCT06363942 | Recruiting

• 1 other identifier: 2024-5973
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

frailty; exercise; older adult; ageing

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Objective 4

  12 weeks

Study Arms (2)

SAFE program

EXPERIMENTAL

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.

Other: SAFE program (exercise intervention)

Control group

NO INTERVENTION

Participants will be asked to continue their activities of daily living without making any changes.

Interventions

SAFE program (exercise intervention) OTHER

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.

SAFE program

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Royal Victoria Hospital - Glen site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 11769786 BACKGROUND

• Al-Aama T. Falls in the elderly: spectrum and prevention. Can Fam Physician. 2011 Jul;57(7):771-6.

  PMID: 21753098 BACKGROUND

• 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.

  PMID: 16926202 BACKGROUND

• 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.

  PMID: 21632004 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 15010086 BACKGROUND

• 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.

  PMID: 5328883 BACKGROUND

MeSH Terms

Conditions

Frailty; Atrophy; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Behavior

Study Officials

• Jose Morais, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Hajj Boutros

CONTACT

514-501-9975; guyelhajj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 12, 2024
• Study Start: July 1, 2024
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon completion of the study.

Locations

CA (1)