Home-based Program "T&E" for Fall Prevention and QoL in Elderly: a Randomised Control Pilot-study

Not Applicable

Completed

• Conditions: Accidental Falls
• Interventions: Other: T&E; Other: OTAGO

• Registration Number: NCT02144506
• Lead Sponsor: HES-SO Valais-Wallis

Brief Summary

The aim of the pilot-study is to evaluate the feasability of a future RCT, regarding recruitement of eligible participants, adhesion rate, datarecording and cost. In this feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to one of two interventions. The control group gets a well-known home-based exercise program (OTAGO) aiming to prevent falls where the exercises are prescribed by a physical therapists. The exercises will be presented on a booklet and on printed cards. The Intervention group consists of an exercise program, the "T\&E" program, where the elderly persons can choose the exercises depending on their abilities. The exercises in the "T\&E" program will be presented in a printed manual and shown on videos on an electronic tablet. Both intervention groups receive 6 hours of instruction and control/supervision sessions by physical therapists. In addition, the participants will exercise alone.

The interventions will be performed over 24 weeks.

In this pilot study, the hypothesis is that the adhesion rate is at least 65%. Other feasibility criteria will be costs, data recording issues and the qualitative evaluation of the booklet and the tablet.

Falls will be assessed with a falls calendar. The amount of physical activity of the participants is assessed with an accelerometers (actigraph) and quality of life will be assessed with OPQOL-35 at baseline, week 16 and week 24.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-22
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Living at home
• Ability to perform standing position independently with/without walking aids (rollator crutch)
• Reported fall(s) during the last 12 months and/or fear of falling (Short FES-I ≥8)
• Understand french / german

Exclusion Criteria

• Actually in treatment with a physical therapist
• Participate at an other home-based programm exercises
• MMS Score ≥ 25.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T&E	T&E	Home-based exercises program "T\&E".This exercise program proposes 50 exercises with a booklet, cards and an electronic tablet. The participants choose their exercises on the basis of a rating scale of perception of exercise difficulty.
OTAGO	OTAGO	Programm "OTAGO" is a home-based exercises program.

Primary Outcome Measures

Name	Time	Method
Adhesion rate	24 weeks	Feasability of a futur study about the recruting processus and adhesion rate (≥ 65%)

Secondary Outcome Measures

Name	Time	Method
Feasability	24 weeks	Feasability about cost, datarecording, qualitativ evaluation of the booklet and the electronic tablet

Trial Locations

Locations (1)

University of Applied Sciences and Arts Western Switzerland; 🇨🇭 Sion, Valais Wallis, Switzerland