Clinical trial NCT05835297: Effect of Specifically Developed Exercise Intervention on Falls Among Older Adults in Nursing Homes
Official title: Effects of Specifically Developed Exercise on Falls, Physical Functioning, Physical Activity, and General Physical and Psychological Well-being Among Older Adults Dwelling in Nursing Homes Following Recommendations of International Association of Gerontology and Geriatrics-Global Aging Research Network (IAGG-GARN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Exercise Intervention
Elderly Population
Keywords: Fall
Exercise
Elderly
Guideline
Risk
Functionality
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to examine the effect of multicomponent exercises recommendations on falls, physical functioning, physical activity, and general physical and psychological well-being among Hungarian older adults dwelling in nursing homes.

Detailed description: Methods: Randomized controlled trial of an individually exercise guideline recommended by IAGG-GARN for older males and females living in a nursing home. A stratified randomization will be performed after the baseline assessment. The assessment of primary and secondary outcomes takes place in all subjects upon entry to the study (pre-test) by blinded assessors and at 12 weeks (post-test). After baseline assessments is completed, participants will be randomly allocated to one of the two groups using stratified randomization based on equal distribution of age and gender ratio.

Expected results:

* Reduce the incidence of falls among the nursing homes residents of the intervention group (IG)
* Increase of lower extremity physical functional ability (balance, gait speed, and strength) of the IG
* Improvement of level of physical activity independency of the IG
* Improvement of functional independency of the IG
* Improvement of physical and psychological well-being among IG.

Eligibility criteria: Inclusion Criteria:

* Willingness to participate
* Males and females aged ≥65 years living in nursing homes
* Physically mobile (capable of ambulating/rising from chair with or without assistance)
* Not under simultaneous physical activity/exercise investigation in other experimental studies or under other exercise rehabilitation programme
* To be able to read and understand the self-reported assessments as well as follow the verbal instructions.

Exclusion Criteria:

* Physically unable or medically unfit to participate in physical exercise after consultation of the responsible medical team
* Score of \< 18 on mini-mental state examination (MMSE).

Primary outcomes:
measure: Number of all falls (non-injurious and injurious)
timeFrame: During the 12-week of the intervention.
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline and 12th week.
measure: Six-minute Walking Test (6MWT)
timeFrame: Baseline and 12th week.
measure: Timed Up and Go Test (TUGT)
timeFrame: Baseline and 12th week.
measure: Single Leg Stance Test (SLST)
timeFrame: Baseline and 12th week.
measure: Functional Reach Test (FRT)
timeFrame: Baseline and 12th week.
measure: Mini-mental State Examination (MMSE)
timeFrame: Baseline and 12th week.
measure: Barthel Index
timeFrame: Baseline and 12th week.
measure: World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
timeFrame: Baseline and 12th week.
measure: World Health Organization Well-Being Index (WHO-5)
timeFrame: Baseline and 12th week.
measure: Geriatrics Depression Scale (GDS)
timeFrame: Baseline and 12th week.
measure: Beck Depression Inventory (BDI-13)
timeFrame: Baseline and 12th week.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 12th week.
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: Baseline and 12th week.
measure: Sedentary Behaviour Questionnaire (SBQ)
timeFrame: Baseline and 12th week.
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs
Study officials:
References: