Accidental FallsPhase 3SwissCHEFNCT02926105
Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults
A Phase 3 study testing T&E Home-based exercise programme, Otago and Helsana booklet in people with Accidental Falls, run by HES-SO Valais-Wallis at 3 sites in Switzerland.
Trial summary
This study compares the effects of three home-based exercise programmes in "at-risk to falling" older adults living in their own home on the incidence of falls (number and severity), risk factors, and quality of life as well as on the adherence to exercise. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- T&E Home-based exercise programme, Otago and Helsana booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Oct 2016to Oct 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old and older,
- Living in their own home,
- Having a history of fall in the previous 12 months or perceiving fear of falling (≥ 20 points on FES-I,
- Being able to walk without auxiliary tools in their home.
- Signed Informed Consent
Who cannot join
- Having severe vision impairment that do not permit the reading of the exercise-programme booklet and that do not permit the completing of the monthly diaries,
- Receiving physiotherapeutic treatment with balance learning,
- Having cognitive impairment (<25 points on the Mini-Mental State Examination (MMSE) of Folstein
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites, 3 recruiting
- Recruiting
CUTR Sylvana
Épalinges, Canton of Vaud, 1066
Constanze Lenoble-Hoskovec, BS, +41 79 556 62 46, constanze.hoskovec@chuv.ch
Isabelle Le Franc-Guégo, BS, +41 79 556 12 86, isbelle.guego@chuv.ch
- Recruiting
HES-SO Valais-Wallis
Leukerbad, Valais, 3954
Nicolas Mathieu, MS, +41 79 300 44 31, nicolas.mathieu@hevs.ch
Annick Bonvin
- Recruiting
Physiotherapie Nevzati
Zurich, Canton of Zurich, 8032
Jaap Swanenburg, PhD, +41 44 261 53 61, cheftrialzurich@bluewin.ch
About this study
Official title: Comparison of the Effects of Three Home-based Exercise Programmes Regarding Falls, Quality of Life and Exercise-adherence in Older Adults at Risk of Falling: Protocol for a Randomised Controlled Trial
This study compares the effects of three home-based exercise programmes in "at-risk to falling" older adults living in their own home on the incidence of falls (number and severity), risk factors, and quality of life as well as on the adherence to exercise. The subjects will be randomized and allocated in three groups. The group A will receive the "Test-and-Exercise" home-based programme (T\&E), the group B will receive the "Otago" home-based exercise programme and the group C (activ-control group) will receive the "Helsana" booklet
Read the detailed description
Home-based exercise programmes appear to reduce rate of falls, number of fallers, risk of falling and risk of death and to improve balance, leg strength, function, physical activity and balance confidence in older adults living in the community.
The Test-and-Exercise home-based programme (T\&E) contains 50 tests and 50 exercises to improve balance, strength and ability in older adults. It is especially built for older adults and is based on the concept of self-efficacy and empowerment. The originality of this programme is the evaluation of the difficulty perceived of the balance-exercises. It is delivered on a booklet which investigators had good experience with in our pilot study, with pictures and descriptions of each test and each exercise. Investigators also developed a mobile application. This application will be transmitted on a tablet-computer. In addition, the participants will receive cards with pictures of the exercises, to put into a plastic sheet to have an overview of their own exercise programme. This programme will be implemented from especially trained physiotherapists.
The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.
The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.
- Conditions
- Accidental Falls
- Being tested
- T&E Home-based exercise programme, Otago, Helsana booklet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T&E Home-based exercise programmeBehavioural
Also called T&E
"T\&E" exercises programme consists of home-based individually tailored balance and functional strength tests and exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months.
OtagoBehavioural
Otago exercises programme consists of home-based individually tailored balance, strength and walking exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months.
Helsana bookletBehavioural
Also called Helsana
Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.
| Study group | Role | What they receive |
|---|---|---|
| T&E Home-based exercise programme | Experimental | Individually tailored home-based test and exercise programme Receives: Behavioral: T&E Home-based exercise programme |
| Otago | Experimental | Individually tailored exercise programme Receives: Behavioral: Otago |
| Helsana booklet | Active comparator | Helsana recommendations and exercises Receives: Behavioral: Helsana booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of falls
Measured: one year
Secondary outcomes (5)
Fear of falling
FES-I
Measured: one year
Severity of falls
Scale of Schwenk 2012
Measured: one year
Risk of fall
Algorithm STEADI
Measured: one year
Quality of life
OPQOL-35
Measured: one year
Exercise adherence
Monthly calender
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Leenaards, Switzerland
- Responsible party
- Sponsor
- Investigators
- Anne-Gabrielle Mittaz Hager, MS, Principal investigator, HES-SO Valais-Wallis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926105
- Sponsor's protocol ID
- CER-00931
- Acronym
- SwissCHEF
- Status last verified
- Nov 2016
- First submitted
- 4 Oct 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Hager AM, Mathieu N, Carrard S, Bridel A, Wapp C, Hilfiker R. Partially supervised exercise programmes for fall prevention improve physical performance of older people at risk of falling: a three-armed multi-centre randomised controlled trial. BMC Geriatr. 2024 Apr 3;24(1):311. doi: 10.1186/s12877-024-04927-0.
PubMed 38570773Mittaz Hager AG, Mathieu N, Lenoble-Hoskovec C, Swanenburg J, de Bie R, Hilfiker R. Effects of three home-based exercise programmes regarding falls, quality of life and exercise-adherence in older adults at risk of falling: protocol for a randomized controlled trial. BMC Geriatr. 2019 Jan 14;19(1):13. doi: 10.1186/s12877-018-1021-y.
PubMed 30642252
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Three Home-based Exercise Programmes Regarding Falls, Quality of Life and Exercise-adherence in Older Adults at Risk of Falling: Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02926105
- Acronym / sponsor ID
- SwissCHEF / CER-00931
- Conditions
- Accidental Falls
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Collaborators
- Fondation Leenaards, Switzerland
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 6 Oct 2016 (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.
This study compares the effects of three home-based exercise programmes in "at-risk to falling" older adults living in their own home on the incidence of falls (number and severity), risk factors, and quality of life as well as on the adherence to exercise. The subjects will be randomized and allocated in three groups. The group A will receive the "Test-and-Exercise" home-based programme (T\&E), the group B will receive the "Otago" home-based exercise programme and the group C (activ-control group) will receive the "Helsana" booklet
Detailed description
Home-based exercise programmes appear to reduce rate of falls, number of fallers, risk of falling and risk of death and to improve balance, leg strength, function, physical activity and balance confidence in older adults living in the community.
The Test-and-Exercise home-based programme (T\&E) contains 50 tests and 50 exercises to improve balance, strength and ability in older adults. It is especially built for older adults and is based on the concept of self-efficacy and empowerment. The originality of this programme is the evaluation of the difficulty perceived of the balance-exercises. It is delivered on a booklet which investigators had good experience with in our pilot study, with pictures and descriptions of each test and each exercise. Investigators also developed a mobile application. This application will be transmitted on a tablet-computer. In addition, the participants will receive cards with pictures of the exercises, to put into a plastic sheet to have an overview of their own exercise programme. This programme will be implemented from especially trained physiotherapists.
The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.
The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T&E Home-based exercise programme | Experimental | Behavioral: T&E Home-based exercise programmeIndividually tailored home-based test and exercise programme |
| Otago | Experimental | Behavioral: OtagoIndividually tailored exercise programme |
| Helsana booklet | Active comparator | Behavioral: Helsana bookletHelsana recommendations and exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years old and older,
- Living in their own home,
- Having a history of fall in the previous 12 months or perceiving fear of falling (≥ 20 points on FES-I,
- Being able to walk without auxiliary tools in their home.
- Signed Informed Consent
Key exclusion criteria (3 listed)
- Having severe vision impairment that do not permit the reading of the exercise-programme booklet and that do not permit the completing of the monthly diaries,
- Receiving physiotherapeutic treatment with balance learning,
- Having cognitive impairment (<25 points on the Mini-Mental State Examination (MMSE) of Folstein
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&E Home-based exercise programmeAlso: T&E"T\&E" exercises programme consists of home-based individually tailored balance and functional strength tests and exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months. | Behavioural | T&E Home-based exercise programme |
| OtagoOtago exercises programme consists of home-based individually tailored balance, strength and walking exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months. | Behavioural | Otago |
| Helsana bookletAlso: HelsanaHelsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months. | Behavioural | Helsana booklet |
Primary outcome
number of falls
Time frame: one year
5 secondary outcomes
Fear of falling
Time frame: one year
Severity of falls
Time frame: one year
Risk of fall
Time frame: one year
Quality of life
Time frame: one year
Exercise adherence
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Derived from this study: PubMed 38570773Hager AM, Mathieu N, Carrard S, Bridel A, Wapp C, Hilfiker R. Partially supervised exercise programmes for fall prevention improve physical performance of older people at risk of falling: a three-armed multi-centre randomised controlled trial. BMC Geriatr. 2024 Apr 3;24(1):311. doi: 10.1186/s12877-024-04927-0.
- Derived from this study: PubMed 30642252Mittaz Hager AG, Mathieu N, Lenoble-Hoskovec C, Swanenburg J, de Bie R, Hilfiker R. Effects of three home-based exercise programmes regarding falls, quality of life and exercise-adherence in older adults at risk of falling: protocol for a randomized controlled trial. BMC Geriatr. 2019 Jan 14;19(1):13. doi: 10.1186/s12877-018-1021-y.
- Trial homepageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Accidental Falls
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
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-Gabrielle Mittaz Hager, MS principal investigator
HES-SO Valais-Wallis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T&E Home-based exercise programme, Otago and Helsana booklet in people with Accidental Falls, run by HES-SO Valais-Wallis at 3 sites 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 5 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Gabrielle Mittaz Hager, MS (+41 79 609 90 63, gaby.mittaz@hevs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of falls (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926105, which also lists 2 linked publications.
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 11 Nov 2016.