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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02144506
Acronym
T&Eelderly
Enrollment
18
Registered
2014-05-22
Start date
2014-05-31
Completion date
2015-09-30
Last updated
2015-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls

Keywords

Elderly, home-based exercises programm

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.

Interventions

OTHERT&E
OTHEROTAGO

Sponsors

HES-SO Valais-Wallis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Adhesion rate24 weeksFeasability of a futur study about the recruting processus and adhesion rate (≥ 65%)

Secondary

MeasureTime frameDescription
Feasability24 weeksFeasability about cost, datarecording, qualitativ evaluation of the booklet and the electronic tablet

Other

MeasureTime frameDescription
Quality of life24 weeksOPQOL-35 questionnaire, at baseline, on the 16st week and end of intervention
Timed Up and Go (TUG) test24 weeksat baseline and at the end of the intervention
Functional Reach test (FR)24 weekdsat baseline and at the end of the intervention
Falls24 weeksmonthly calendar
Five Time Sit to Stand (FTSTS)24 weeksat baseline and at the end of the intervention
Walking speed24 weeksat baseline and at the end of the intervention
Four-Test balance scale24 weeksat the baseline and at the end of the intervention
Physical activity24 weeks6 monthly calendars and accelerometer (baseline and 16st week)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026