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

Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Frailty Syndrome; Pre-frail Older Adults
• Intervention / Treatment: Other: Physical Function Exercises

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Crete
    • Heraklion, Crete, Greece, 71410
      • Hellenic Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Function Group; Physical function interventions including strength, balance, and mobility exercises	Other: Physical Function Exercises; Physical function interventions included strength, balance, and mobility exercises. More specifically, the exercises include progressively increasing intensity strengthening exercises with a resistance band for the following muscle groups: hip abductor and extensor muscles, knee flexor and extensor muscles, and shoulder abductor and external rotator muscles. Other exercises consist of standing calf raises, squats, bridges, and push-ups. Additionally, functional exercises include heel-to-toe standing or walking, single-leg standing, stepping over obstacles, bending down, and lifting an object with feet together.; Other Names: Targeted Physical Function Exercises
No Intervention: Control Group; Will continue their normal lives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Frailty status	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	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Concerns about Falling	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.	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Performance	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.	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Functional Mobility	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.	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Functional Balance	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.	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	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.	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Depression	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.	From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).

Collaborators and Investigators

• Sponsor: Hellenic Mediterranean University
• Investigators: Principal Investigator: Konstantinos Giakoumidakis, Hellenic Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: October 26, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Frailty; Concerns about Falling; Physical Function exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 3589/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No