Effect of Specifically Developed Exercise Intervention on Falls Among Older Adults in Nursing Homes

Fall Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05835297
• Other study ID #: 9283 - PTE 2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Elderly Population
• Exercise Intervention
• Fall

Intervention

Other:
• Physical exercise interventions
Participants will undergo a 12-week multicomponent exercise regimen, twice per week on non-consecutive days for 45-60 min each. The session will be divided into 4 min of warm-up; range of motion exercises of upper and lower extremities, followed by light walking, then 8 min balance exercises, followed by 15 min strength exercises; two sets of 13-15 repetitions maximum of chair rises with progression, two sets of 13-15 repetitions of modified squats (holding a chair backrest if needed) with progression, 2 sets of 20-30 repetitions of seated or 2 sets of 13-15 repetitions of standing calf raises, then 15 min aerobic exercises; five 3-min bouts of walking between two strengthening exercises and/or 2 balance exercises, finally 3 min cool down exercises of light walking and stretching exercises.

Locations

Country	Name	City	State
Hungary	University of Pécs	Pécs

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of all falls (non-injurious and injurious)	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).	During the 12-week of the intervention.
Secondary	Short Physical Performance Battery (SPPB)	An instrument to test the lower extremity functionality, it consists of 3 types of balance tests (side-by-side stand, semi-tandem stand, tandem stand), a 4-m gait speed test, and a chair sit-to-stand test. Each domain is scored between 0 and 4 and the overall score ranges from 0 (low mobility/functionality) to 12 (full mobility/ functionality).	Baseline and 12th week.
Secondary	Six-minute Walking Test (6MWT)	A timed walk test used to evaluate physical function related to lower extremities strength and mobility. Participants will walk the longest distance possible within 6 min. The outcome is the total walking distance in meters, with higher score indicates better performance.	Baseline and 12th week.
Secondary	Timed Up and Go Test (TUGT)	A test to measure functional mobility. The outcome measure will be time in seconds, taken to stand up from a chair, walk 3 m, turn, return to the chair, and sit down. Lower score indicates better performance.	Baseline and 12th week.
Secondary	Single Leg Stance Test (SLST)	A test to evaluate the static balance capability. Participants will be asked to stand barefoot on 1leg with eyes open on firm surface for as long as possible; the time in seconds will be recorded using a stopwatch. The participants will complete 3 trials on each leg, and a mean score will be calculated for each leg.	Baseline and 12th week.
Secondary	Functional Reach Test (FRT)	A test to evaluate dynamic balance through measuring the maximal distance participants are able to reach forward while standing or sitting on a chair. 3 trials are done and the average of the last two is noted, with longer distance to reach forward indicates better performance.	Baseline and 12th week.
Secondary	Mini-mental State Examination (MMSE)	A tool used to evaluate cognitive function (scored from 0 to 30; scores below 24 indicate cognitive impairment) through 11 items.	Baseline and 12th week.
Secondary	Barthel Index	A tool is used to record the independence of participants when performing basic activities of daily living (ADLs) via ten items. Feeding, personal toileting, bathing, dressing, and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs are rated on a scale from 0 to 15 points depending on the item. Total possible scores range from 0 (totally dependent) to 100 (fully independent).	Baseline and 12th week.
Secondary	World Health Organization Quality of Life questionnaire (WHOQOL-BREF)	A self-administered questionnaire consists of 26 items, evaluating participants' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".	Baseline and 12th week.
Secondary	World Health Organization Well-Being Index (WHO-5)	A self-reported rating scale of 5 items, measuring subjective psychological well-being.; The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25.To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.	Baseline and 12th week.
Secondary	Geriatrics Depression Scale (GDS)	A self-rated depression scale of 15 items, that identify symptoms of depression in older adults. A score of = 5 suggests depression.	Baseline and 12th week.
Secondary	Beck Depression Inventory (BDI-13)	A 13-question multiple-choice self-report inventory for measuring the severity of depression. A score of = 7 indicates mild depression.	Baseline and 12th week.
Secondary	Pittsburgh Sleep Quality Index (PSQI)	A self-reported scale for measuring patterns and quality of sleep in adults via 19 items. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower score indicates a healthier sleep quality.	Baseline and 12th week.
Secondary	Global Physical Activity Questionnaire (GPAQ)	The GPAQ version 2 developed by WHO will be used. It comprises 16 self-administered questions that collect information on physical activity in three settings (or domains) as well as sedentary behaviour of a week (7 days).	Baseline and 12th week.
Secondary	Sedentary Behaviour Questionnaire (SBQ)	A self-reported assessment of the amount of time spent doing 9 behaviours separately for weekdays and weekend days. (watching television, playing on a computer/video game, sitting while listening to music, sitting and talking on the phone, doing paperwork or office work, sitting and was reading, playing a musical instrument, doing arts and crafts, sitting and driving/riding in a car, bus, or train).; Scoring: Convert all times into hours (e.g. a response of 15 minutes or less is recoded as 0.25 and 30 minutes is recoded as 0.5).; For total scores of sedentary behavior, sum the hours per day separately for weekday and weekend items.; To obtain weekly estimates, weekday hours are multiplied by 5 and weekend hours are multiplied by 2 and these are summed for total hours per week.; Estimates over 24 hours per day are truncated to 24 hours per day	Baseline and 12th week.