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

NCT ID: NCT06731712

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-06-15

Brief Summary

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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

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Conditions

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Frailty Syndrome Pre-frail Older Adults

Keywords

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Frailty Concerns about Falling Physical Function exercises

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physical Function Group

Physical function interventions including strength, balance, and mobility exercises

Group Type EXPERIMENTAL

Physical Function Exercises

Intervention Type 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.

Control Group

Will continue their normal lives

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Targeted Physical Function Exercises

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hellenic Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Giakoumidakis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Konstantinos Giakoumidakis

Role: PRINCIPAL_INVESTIGATOR

Hellenic Mediterranean University

Locations

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Hellenic Mediterranean University

Heraklion, Crete, Greece

Site Status

Countries

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Greece

Other Identifiers

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3589/2020

Identifier Type: -

Identifier Source: org_study_id