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

Tests and Exercises Home-based Program "T&E" for Fall Prevention and Quality of Life in Elderly: a Randomised Control Pilot-study

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.

Study Overview

• Status: Completed
• Conditions: Accidental Falls
• Intervention / Treatment: Other: T&E; Other: OTAGO

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Valais Wallis
    • Sion, Valais Wallis, Switzerland, (CH) 1950
      • University of Applied Sciences and Arts Western Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: T&E; Other Names: Home-based exercises programm "T&E"
Active Comparator: OTAGO; Programm "OTAGO" is a home-based exercises program.	Other: OTAGO; Other Names: Home-based exercises program "OTAGO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesion rate	Feasability of a futur study about the recruting processus and adhesion rate (≥ 65%)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasability	Feasability about cost, datarecording, qualitativ evaluation of the booklet and the electronic tablet	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	monthly calendar	24 weeks
Physical activity	6 monthly calendars and accelerometer (baseline and 16st week)	24 weeks
Quality of life	OPQOL-35 questionnaire, at baseline, on the 16st week and end of intervention	24 weeks
Timed Up and Go (TUG) test	at baseline and at the end of the intervention	24 weeks
Functional Reach test (FR)	at baseline and at the end of the intervention	24 weekds
Four-Test balance scale	at the baseline and at the end of the intervention	24 weeks
Five Time Sit to Stand (FTSTS)	at baseline and at the end of the intervention	24 weeks
Walking speed	at baseline and at the end of the intervention	24 weeks

Collaborators and Investigators

• Sponsor: HES-SO Valais-Wallis
• Investigators: Study Director: Anne Jacquier-Delaloye, Master, Direction

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Elderly, home-based exercises programm
• Other Study ID Numbers: 37715