Home Exercises for Fall-related Variables in Elderly Adults

NCT05337839 | Completed

• 1 other identifier: 21102021TK
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Community-dwelling Older Adults

Outcome Measures

Primary Outcomes (1)

• Falls efficacy

  It was assessed using the Falls Efficacy Scale International (FES-I). FES-I is a self-rating questionnaire designed for measuring concerns about the possibility of falling during several activities of daily living. In total, sixteen practices and activities, which are carried out at home such as cooking, dressing, taking a bath; and out of home such as visiting someone, walking on an uneven surface or shopping are scored between 1 and 4 (1 = not at all concerned, 4 = very concerned). The range of total score varies between 16 to 64 and the higher the score the lower the falls efficacy. The investigators have aimed to measure the change in falls efficacy between three time points (baseline, eighth week, sixth month)in order to explore whether there is an improvement in this outcome measure. The change in falls efficacy was calculated by using suitable nonparametric statistical analysis methods.

  baseline, eighth week, sixth month

Secondary Outcomes (5)

• Fear of Falling (FOF)

  baseline, eighth week, sixth month

• Functional Mobility

  baseline, eighth week, sixth month

• Balance Performance

  baseline, eighth week, sixth month

• Fall risk

  baseline, eighth week, sixth month

• Geriatric Depression Scale Short Form (GDS-SF)

  baseline, eighth week, sixth month

Study Arms (2)

Community-dwelling older adults receiving supervision

EXPERIMENTAL

Group I; supervised home exercise group

Procedure: home exercises

Community-dwelling older adults not supervised

ACTIVE COMPARATOR

Group II; unsupervised home exercise group

Procedure: home exercises

Interventions

home exercises PROCEDURE

stretching, balance and strengthening exercises

Community-dwelling older adults not supervised; Community-dwelling older adults receiving supervision

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Related Publications (5)

• 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.

  PMID: 28806904 BACKGROUND

• 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.

  PMID: 26645282 BACKGROUND

• 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.

  PMID: 28090182 BACKGROUND

• 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.

  PMID: 25241278 BACKGROUND

• Avci Trakyali A, Kaya T, Ince B. Effects of an exercise program combining unsupervised home exercises and supervised group-based exercises on fall-related variables in older adults: a randomized controlled trial. Eur Geriatr Med. 2023 Feb;14(1):59-67. doi: 10.1007/s41999-022-00724-3. Epub 2022 Dec 14.

  PMID: 36515868 DERIVED

Study Officials

• Taciser Kaya, Prof., MD

  Izmir Bozyaka Training and Reseach Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants were informed that they will be requested to do stretching, balance and strengthening exercises. None of the participants did know about the presence of another supervised/unsupervised group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 20, 2022
• Study Start: February 20, 2012
• Primary Completion: July 20, 2013
• Study Completion: October 20, 2013
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share