Clinical trial NCT05337839: Home Exercises for Fall-related Variables in Elderly Adults
Official title: Effects of Supervised Versus Unsupervised Home Exercises on Fall-related Variables for Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-dwelling Older Adults
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Seventy-five person all of whom eligible and willing were allocated to "supervised home exercise" group (group 1) or "home exercise" group (group 2) using blocked randomisation method. Subjects who have not agreed to join the supervised home exercise group were not invited to join the home exercise group or vice versa.
Primary purpose: TREATMENT

Brief summary: The aim was to measure and compare the effects of supervised and unsupervised home exercises on the fall related variables.

Detailed description: There are several studies investigating the beneficial effects of exercise on physical function among elderly. However the trials that reporting beneficial effects of an exercise programme on psychosocial functions such as depression and falls efficacy are scarcend. And also these trials are designed to compare fully supervised experimental group with a control group receiving usual care. In only one, out of these studies, supervision was minimal and delivered via home visit. However no psychosocial function related outcome measure was evaluated. In the present study the investigators have intended to assess the effects of minimally supervised home exercise programme on physical and psychosocial fall related variables by comparing with unsupervised home exercise programme in community-dwelling older adults.

Eligibility criteria: Inclusion Criteria:

* Ability to perform timed up and go (TUG) test
* not having regular exercise habit
* a score above 20 on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

* medical conditions impeding to perform exercises such as severe musculoskeletal and neurological disease, severe visual impairment, cardiovascular, pulmonary or malignant disease

Primary outcomes:
measure: Falls efficacy
timeFrame: baseline, eighth week, sixth month
Secondary outcomes:
measure: Fear of Falling (FOF)
timeFrame: baseline, eighth week, sixth month
measure: Functional Mobility
timeFrame: baseline, eighth week, sixth month
measure: Balance Performance
timeFrame: baseline, eighth week, sixth month
measure: Fall risk
timeFrame: baseline, eighth week, sixth month
measure: Geriatric Depression Scale Short Form (GDS-SF)
timeFrame: baseline, eighth week, sixth month
Other outcomes:
Locations:
Study officials:
affiliation: Izmir Bozyaka Training and Reseach Hospital
name: Taciser Kaya, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjerk M, Brovold T, Skelton DA, Bergland A. A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial. BMC Health Serv Res. 2017 Aug 14;17(1):559. doi: 10.1186/s12913-017-2516-5.
citation: Lacroix A, Kressig RW, Muehlbauer T, Gschwind YJ, Pfenninger B, Bruegger O, Granacher U. Effects of a Supervised versus an Unsupervised Combined Balance and Strength Training Program on Balance and Muscle Power in Healthy Older Adults: A Randomized Controlled Trial. Gerontology. 2016;62(3):275-88. doi: 10.1159/000442087. Epub 2015 Dec 9.
citation: Youssef EF, Shanb AA. Supervised Versus Home Exercise Training Programs on Functional Balance in Older Subjects. Malays J Med Sci. 2016 Nov;23(6):83-93. doi: 10.21315/mjms2016.23.6.9. Epub 2016 Dec 7.
citation: Rapp K, Freiberger E, Todd C, Klenk J, Becker C, Denkinger M, Scheidt-Nave C, Fuchs J. Fall incidence in Germany: results of two population-based studies, and comparison of retrospective and prospective falls data collection methods. BMC Geriatr. 2014 Sep 20;14:105. doi: 10.1186/1471-2318-14-105.