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Community-dwelling Older AdultsNCT05337839

Home Exercises for Fall-related Variables in Elderly Adults

A study testing home exercises in people with Community-dwelling Older Adults, run by Bozyaka Training and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim was to measure and compare the effects of supervised and unsupervised home exercises on the fall related variables. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Community-dwelling Older Adults
What is being tested?
home exercises
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
No sites listed yet
Study dates
20 Feb 2012to 20 Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

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

About this study

Official title: Effects of Supervised Versus Unsupervised Home Exercises on Fall-related Variables for Community-dwelling Older Adults

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

Read the 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.

Being tested
home exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • home exercisesProcedure or surgery

    stretching, balance and strengthening exercises

Study groups in NCT05337839
Study groupRoleWhat they receive
Community-dwelling older adults receiving supervisionExperimentalGroup I; supervised home exercise group
Receives: Procedure: home exercises
Community-dwelling older adults not supervisedActive comparatorGroup II; unsupervised home exercise group
Receives: Procedure: home exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, eighth week, sixth month

Secondary outcomes (5)

  1. Fear of Falling (FOF)

    Visual Analog Scale (VAS) was used for measuring FOF subjectively. Participants were asked to indicate the degree of falling fear by making a mark on a 100 milimeter line (zero; not at all, 100; maximum fear). A new paper sheet was used at each visit so that the participants couldn't see the previous response that they have given. This was done with the purpose of prevent them from getting biased.

    Measured: baseline, eighth week, sixth month

  2. Functional Mobility

    To assess functional mobility Timed up and go (TUG) test was used. Participants were requested to walk at their ordinary walking speed during TUG test. They were seated at the beginning of the test and asked for rising from chair after the command "ready-set-go", walking 3 meters, turning around, going back to chair and sitting down again. Duration between rising from chair and sitting down was recorded with a stopwatch. Before testing, participants were instructed about testing procedure and one test trial was performed for this purpose.

    Measured: baseline, eighth week, sixth month

  3. Balance Performance

    With the aim of rating balance performance, Balance Performance Oriented Mobility Assessment (BPOMA) of Tinetti was used. In this test, eight different tasks are scored between 0-2. Maximum possible score is 16 and higher score is related to the better balance performance. For detailed information; this test evaluates sitting and standing balance, turning 360°, the ability of arising from chair and sitting down.

    Measured: baseline, eighth week, sixth month

  4. Fall risk

    Elderly Falls Screening Test (EFST) was used to assess risk of fall. It is composed of two parts, one of which queries fall number in the last year, history of injurious fall and near fall; the second evaluates walking speed and style. The first part is self-report and covers three items; the second part is scored by assessor and covers two items. Maximum possible score is five. A score between 0-1 indicates low, 2-3 moderate and 4-5 high fall risk.

    Measured: baseline, eighth week, sixth month

  5. Geriatric Depression Scale Short Form (GDS-SF)

    This scale is used for defining the depressive symptoms. It covers fifteen dichotomous questions that ask participants to answer in a yes or no fashion. Of the 15 questions, 10 indicate the presence of depression when answered as yes while remaining five indicate the presence of depression when answered as no. An answer in the direction of depression is assumed as one point. To get a final score, all points are summed. Thus, total score is between 0-15. A score between 0-5 is normal, a score above 5 suggests depression.

    Measured: baseline, eighth week, sixth month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start20 Feb 2012
  3. Primary completion20 Jul 2013
  4. Study completion20 Oct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337839
Sponsor's protocol ID
21102021TK
Status last verified
Apr 2022
First submitted
1 Apr 2022
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28806904

  • 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.

    PubMed 26645282

  • 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.

    PubMed 28090182

  • 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.

    PubMed 25241278

  • 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.

    PubMed 36515868

Questions about this trial

What is this clinical trial studying?

A study testing home exercises in people with Community-dwelling Older Adults, run by Bozyaka Training and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Falls efficacy (time frame: baseline, eighth week, sixth month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05337839, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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