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

NCT06731712 | Completed

• 1 other identifier: 3589/2020
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome; Pre-frail Older Adults

Keywords

Frailty; Concerns about Falling; Physical Function exercises

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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).

Study Arms (2)

Physical Function Group

EXPERIMENTAL

Physical function interventions including strength, balance, and mobility exercises

Other: Physical Function Exercises

Control Group

NO INTERVENTION

Will continue their normal lives

Interventions

Physical Function Exercises OTHER

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.

Also known as: Targeted Physical Function Exercises

Physical Function Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Mediterranean University: lead

Study Sites (1)

Hellenic Mediterranean University

Heraklion, Crete, 71410, Greece

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Konstantinos Giakoumidakis

  Hellenic Mediterranean University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: December 12, 2024
• Study Start: December 15, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)