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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pecs
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of all falls (non-injurious and injurious)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
Exercise group
Physical exercise interventions for 45 min, twice a week plus usual care provided at the nursing home.
Intervention: Physical exercise interventions (Other)
Usual care
Usual care provided at the nursing home with no specific physical exercise intervention.
Outcomes
Primary Outcomes
Number of all falls (non-injurious and injurious)
Time Frame: During the 12-week of the intervention.
Whenever a fall occurred for any of the participants during intervention time, it will be recorded by the staff and reported on a fall incidence report. All fall will be reported; non-injurious (i.e., does not result in a physical harm), moderate injurious falls (i.e., result in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days, or if the participant sought medical help), and serious injurious falls (i.e., result in a fracture or admission to hospital with an injury or required stitches).
Secondary Outcomes
- World Health Organization Quality of Life questionnaire (WHOQOL-BREF)(Baseline and 12th week.)
- Six-minute Walking Test (6MWT)(Baseline and 12th week.)
- Single Leg Stance Test (SLST)(Baseline and 12th week.)
- Mini-mental State Examination (MMSE)(Baseline and 12th week.)
- Barthel Index(Baseline and 12th week.)
- Timed Up and Go Test (TUGT)(Baseline and 12th week.)
- Functional Reach Test (FRT)(Baseline and 12th week.)
- Beck Depression Inventory (BDI-13)(Baseline and 12th week.)
- Global Physical Activity Questionnaire (GPAQ)(Baseline and 12th week.)
- Short Physical Performance Battery (SPPB)(Baseline and 12th week.)
- World Health Organization Well-Being Index (WHO-5)(Baseline and 12th week.)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and 12th week.)
- Sedentary Behaviour Questionnaire (SBQ)(Baseline and 12th week.)
- Geriatrics Depression Scale (GDS)(Baseline and 12th week.)
Investigators
Munseef Sadaqa
Principal Investigator (PhD candidate)
University of Pecs