Accidental Falls"T&E"elderlyNCT02144506
Home-based Program "T&E" for Fall Prevention and QoL in Elderly: a Randomised Control Pilot-study
A study testing T&E and OTAGO in people with Accidental Falls, run by HES-SO Valais-Wallis at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- T&E and OTAGO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Actually in treatment with a physical therapist
- Participate at an other home-based programm exercises
- MMS Score ≥ 25.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Applied Sciences and Arts Western Switzerland
Sion, Valais Wallis, (CH) 1950
About this 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
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.
Read more
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.
- Conditions
- Accidental Falls
- Being tested
- T&E, OTAGO
- Keywords
- Elderly, home-based exercises programm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T&EOther
Also called Home-based exercises programm "T&E"
OTAGOOther
Also called Home-based exercises program "OTAGO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: T&E |
| OTAGO | Active comparator | Programm "OTAGO" is a home-based exercises program. Receives: Other: OTAGO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion rate
Feasability of a futur study about the recruting processus and adhesion rate (≥ 65%)
Measured: 24 weeks
Secondary outcomes (1)
Feasability
Feasability about cost, datarecording, qualitativ evaluation of the booklet and the electronic tablet
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mittaz Hager Anne-Gabrielle, HES-SO Valais-Wallis
- Investigators
- Anne Jacquier-Delaloye, Master, Study director, Direction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144506
- Sponsor's protocol ID
- 37715
- Acronym
- "T&E"elderly
- Status last verified
- Sep 2015
- First submitted
- 19 May 2014
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tests and Exercises Home-based Program "T&E" for Fall Prevention and Quality of Life in Elderly: a Randomised Control Pilot-study
- ClinicalTrials.gov ID
- NCT02144506
- Acronym / sponsor ID
- "T&E"elderly / 37715
- Conditions
- Accidental Falls
- Keywords
- Elderly, home-based exercises programm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T&E | Experimental | Other: T&EHome-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. |
| OTAGO | Active comparator | Other: OTAGOProgramm "OTAGO" is a home-based exercises program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Actually in treatment with a physical therapist
- Participate at an other home-based programm exercises
- MMS Score ≥ 25.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T&EAlso: Home-based exercises programm "T&E" | Other | T&E |
| OTAGOAlso: Home-based exercises program "OTAGO | Other | OTAGO |
Primary outcome
Adhesion rate
Time frame: 24 weeks
Feasability of a futur study about the recruting processus and adhesion rate (≥ 65%)
1 secondary outcome
Feasability
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Jacquier-Delaloye, Master study director
Direction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T&E and OTAGO in people with Accidental Falls, run by HES-SO Valais-Wallis at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2015.