Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Frailty Syndrome
- Sponsor
- Hellenic Mediterranean University
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Level of Frailty status
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The investigators will conduct a randomized controlled trial to assess the impact of targeted physical function exercises on frailty and falls in community-dwelling adults over 65 years of age. Participants will be randomized to an intervention and a control group to undergo an 18-month assessment.
The hypothesis of this study is to investigate the impact of targeted physical function exercises on managing frailty status and concerns about falling among pre-frail older adults. By implementing individualized intervention programs tailored to improve strength, balance, and mobility, the investigators aim to enhance physical function and reduce the risk of frailty-related adverse health outcomes. The investigators seek to empower pre-frail older adults to proactively manage their health, maintain independence, and improve their quality of life as they age.
Investigators
Konstantinos Giakoumidakis
Associate Professor
Hellenic Mediterranean University
Eligibility Criteria
Inclusion Criteria
- •participants aged 65 and over
- •classified as pre-frail according to SHARE-Frailty Instrument
- •independent of movement and activity
- •able to perform Mini-Mental Status Examination (MMSE) score ≥24
Exclusion Criteria
- •severe contraindications for physical exercise
- •central nervous system impairments
- •inability to speak and understand Greek properly
- •a cognitive state that prevents understanding the researcher's instructions
Outcomes
Primary Outcomes
Level of Frailty status
Time Frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
SHARE Frailty Instrument will be used. Diagnostic criteria include involuntary loss of weight and muscle mass, exhaustion, low physical activity, slowness, and reduced grip strength. The presence of three or more criteria indicates frailty, while the presence of less than three pre-frailty
Concerns about Falling
Time Frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
The Falls Efficacy Scale - International (FES-I), a 16-item questionnaire that assesses the participant's fall efficacy, will be used to measure the level of concern about falling during various social and physical activities. Every item has a four-point (1-4) score, summarizing a total score of 64 points. A 16-22 score indicates low concern about falling, and a 23-64 high concern.
Secondary Outcomes
- Physical Performance(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Functional Mobility(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Functional Balance(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Quality of Daily Living(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Depression(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)