Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults

Not Applicable

Completed

• Conditions: Frailty Syndrome; Pre-frail Older Adults

• Registration Number: NCT06731712
• Lead Sponsor: Hellenic Mediterranean University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15
• Status Verified: 2024-10
• Study First Submitted: 2024-10-26
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Level of Frailty status	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	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 Outcome Measures

Name	Time	Method
Physical Performance	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).	The Short Physical Performance Battery (SPPB) will be used to assess physical performance. It is an assessment tool consisting of 3 tests in three different domains (walking, sit-to-stand, and balance) to assess function: a 3- or 4-meter walking time at the usual speed, one single chair stand, and time to complete five chair stands, and three balance tests of progressive difficulty, holding for 10 seconds (side-by-side, semi-tandem, tandem stand). Each test is rated on a scale of 0 to 4, summed to give an overall score ranging from 0 to 12, with a higher score indicating better performance.
Functional Mobility	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).	For quantifying functional mobility, the Time Up and Go test (TUG) will be used. Participants will be observed and timed while standing up from an armchair, walking three meters, making a turn, and returning to their sitting position. The timer will start when the participants are ready to stand up and stop when they return sitter.
Functional Balance	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).	The Berg Balance Scale (BBS) will be used to assess a participant's ability to balance safely during specific tasks. It evaluates dynamic and static balance through 14 functional tasks, with each task answered on a five-point scale ranging from 0, indicating the lowest level of functioning, to 4, the highest level of functioning. The final summary score ranges from 0 to 56.
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).	To assess the quality of life of the participants, the WHOQOL-BREF scale will be used, which includes 26 items concerning 4 domains of health (physical health, psychological health, social relationships, and environment) and 4 additional items concerning nutrition, satisfaction with work, home life, and social life. Each item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100 scale.
Depression	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).	The short-form Geriatric Depression Scale (GDS), consisting of 15 yes-or-no questions with a total score range of 0 to 15, was used to assess the participant's depressive symptoms. A score of 0 to 5 is normal. A score greater than 5 suggests depression.

Trial Locations

Locations (1)

Hellenic Mediterranean University; 🇬🇷 Heraklion, Crete, Greece