Clinical trial NCT02144506: Home-based Program "T&E" for Fall Prevention and QoL in Elderly: a Randomised Control Pilot-study
Official title: Tests and Exercises Home-based Program "T&E" for Fall Prevention and Quality of Life in Elderly: a Randomised Control Pilot-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Elderly, home-based exercises programm
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adhesion rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Feasability
timeFrame: 24 weeks
Other outcomes:
measure: Falls
timeFrame: 24 weeks
measure: Physical activity
timeFrame: 24 weeks
measure: Quality of life
timeFrame: 24 weeks
measure: Timed Up and Go (TUG) test
timeFrame: 24 weeks
measure: Functional Reach test (FR)
timeFrame: 24 weekds
measure: Four-Test balance scale
timeFrame: 24 weeks
measure: Five Time Sit to Stand (FTSTS)
timeFrame: 24 weeks
measure: Walking speed
timeFrame: 24 weeks
Locations:
city: Sion
country: Switzerland
facility: University of Applied Sciences and Arts Western Switzerland
state: Valais Wallis
Study officials:
affiliation: Direction
name: Anne Jacquier-Delaloye, Master
role: STUDY_DIRECTOR
References: