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

Accidental Falls Clinical Trial

— "T&E"elderly  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144506
• Other study ID #: 37715
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: September 9, 2015
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: HES-SO Valais-Wallis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• T&E

• OTAGO

Locations

Country	Name	City	State
Switzerland	University of Applied Sciences and Arts Western Switzerland	Sion	Valais Wallis

Sponsors (1)

Lead Sponsor	Collaborator
HES-SO Valais-Wallis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Falls	monthly calendar	24 weeks
Other	Physical activity	6 monthly calendars and accelerometer (baseline and 16st week)	24 weeks
Other	Quality of life	OPQOL-35 questionnaire, at baseline, on the 16st week and end of intervention	24 weeks
Other	Timed Up and Go (TUG) test	at baseline and at the end of the intervention	24 weeks
Other	Functional Reach test (FR)	at baseline and at the end of the intervention	24 weekds
Other	Four-Test balance scale	at the baseline and at the end of the intervention	24 weeks
Other	Five Time Sit to Stand (FTSTS)	at baseline and at the end of the intervention	24 weeks
Other	Walking speed	at baseline and at the end of the intervention	24 weeks
Primary	Adhesion rate	Feasability of a futur study about the recruting processus and adhesion rate (= 65%)	24 weeks
Secondary	Feasability	Feasability about cost, datarecording, qualitativ evaluation of the booklet and the electronic tablet	24 weeks