NCT02144506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

May 19, 2014

Last Update Submit

September 9, 2015

Conditions

Accidental Falls

Keywords

Elderly, home-based exercises programm

Outcome Measures

Primary Outcomes (1)

  • Adhesion rate

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

    24 weeks

Secondary Outcomes (1)

  • Feasability

    24 weeks

Other Outcomes (8)

  • Falls

    24 weeks

  • Physical activity

    24 weeks

  • Quality of life

    24 weeks

  • +5 more other outcomes

Study Arms (2)

T&E

EXPERIMENTAL

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

OTAGO

ACTIVE COMPARATOR

Programm "OTAGO" is a home-based exercises program.

Other: OTAGO

Interventions

T&EOTHER
Also known as: Home-based exercises programm "T&E"
T&E
OTAGOOTHER
Also known as: Home-based exercises program "OTAGO
OTAGO

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Actually in treatment with a physical therapist
  • Participate at an other home-based programm exercises
  • MMS Score ≥ 25.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Applied Sciences and Arts Western Switzerland

Sion, Valais Wallis, (CH) 1950, Switzerland

Location

Study Officials

  • Anne Jacquier-Delaloye, Master

    Direction

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 22, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

CH(1)