Skip to main content
OpenTrials
Completed

NCT Number: NCT02144506

Home-based Program "T&E" for Fall Prevention and QoL 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Accidental Falls

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Applied Sciences and Arts Western Switzerland

Sion, Valais Wallis, (CH) 1950, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T&E

Other

Other names: Home-based exercises programm "T&E"

OTAGO

Other

Other names: Home-based exercises program "OTAGO

Primary outcomes

  1. Adhesion rate

    Time frame: 24 weeks

    Feasability of a futur study about the recruting processus and adhesion rate (≥ 65%)

Secondary outcomes

  1. Feasability

    Time frame: 24 weeks

    Feasability about cost, datarecording, qualitativ evaluation of the booklet and the electronic tablet

Other outcomes

  1. Falls

    Time frame: 24 weeks

    monthly calendar

  2. Physical activity

    Time frame: 24 weeks

    6 monthly calendars and accelerometer (baseline and 16st week)

  3. Quality of life

    Time frame: 24 weeks

    OPQOL-35 questionnaire, at baseline, on the 16st week and end of intervention

  4. Timed Up and Go (TUG) test

    Time frame: 24 weeks

    at baseline and at the end of the intervention

  5. Functional Reach test (FR)

    Time frame: 24 weekds

    at baseline and at the end of the intervention

  6. Four-Test balance scale

    Time frame: 24 weeks

    at the baseline and at the end of the intervention

  7. Five Time Sit to Stand (FTSTS)

    Time frame: 24 weeks

    at baseline and at the end of the intervention

  8. Walking speed

    Time frame: 24 weeks

    at baseline and at the end of the intervention

Sponsors and collaborators

Lead sponsor

HES-SO Valais-Wallis

Other

Registry information

Official study title

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

Acronym: "T&E"elderly

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 22, 2014
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.