Home Exercises for Fall-related Variables in Elderly Adults

Study Overview
=================
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.

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

Conditions
-----------------
Community-dwelling Older Adults

Intervention / Treatment
-----------------
* Procedure: home exercises


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community-dwelling older adults receiving supervision<br>Group I; supervised home exercise group | Procedure: home exercises<br>* stretching, balance and strengthening exercises<br>|
| Active Comparator: Community-dwelling older adults not supervised<br>Group II; unsupervised home exercise group | Procedure: home exercises<br>* stretching, balance and strengthening exercises<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, eighth week, sixth month | 
| 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. | baseline, eighth week, sixth month | 
| 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. | baseline, eighth week, sixth month | 
| 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. | baseline, eighth week, sixth month | 
| 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. | baseline, eighth week, sixth month |