Clinical trial NCT06731712: Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults
Official title: Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty Syndrome
Pre-frail Older Adults
Keywords: Frailty
Concerns about Falling
Physical Function exercises
Lead sponsor: Hellenic Mediterranean University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 121
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Level of Frailty status
timeFrame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
measure: Concerns about Falling
timeFrame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Secondary outcomes:
measure: Physical Performance
timeFrame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
measure: Functional Mobility
timeFrame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
measure: Functional Balance
timeFrame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
measure: Quality of Daily Living
timeFrame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
measure: Depression
timeFrame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Hellenic Mediterranean University
state: Crete
Study officials:
affiliation: Hellenic Mediterranean University
name: Konstantinos Giakoumidakis
role: PRINCIPAL_INVESTIGATOR
References: