Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults

NCT ID: NCT02926105

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Accidental Falls

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

T&E Home-based exercise programme

Individually tailored home-based test and exercise programme

Group Type EXPERIMENTAL

T&E Home-based exercise programme

Intervention Type BEHAVIORAL

"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.

Otago

Individually tailored exercise programme

Group Type EXPERIMENTAL

Otago

Intervention Type BEHAVIORAL

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 booklet

Helsana recommendations and exercises

Group Type ACTIVE_COMPARATOR

Helsana booklet

Intervention Type BEHAVIORAL

Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

T&E Home-based exercise programme

"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.

Intervention Type BEHAVIORAL

Otago

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.

Intervention Type BEHAVIORAL

Helsana booklet

Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

T&E Helsana

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Leenaards, Switzerland

UNKNOWN

Sponsor Role collaborator

HES-SO Valais-Wallis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne-Gabrielle Mittaz Hager, MS

Role: PRINCIPAL_INVESTIGATOR

HES-SO Valais-Wallis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CUTR Sylvana

Épalinges, Canton of Vaud, Switzerland

Site Status RECRUITING

Physiotherapie Nevzati

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

HES-SO Valais-Wallis

Leukerbad, Valais, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anne-Gabrielle Mittaz Hager, MS

Role: CONTACT

Phone: +41 79 609 90 63

Email: [email protected]

Roger Hilfiker, MS

Role: CONTACT

Phone: +41 79 688 34 90

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Constanze Lenoble-Hoskovec, BS

Role: primary

Isabelle Le Franc-Guégo, BS

Role: backup

Jaap Swanenburg, PhD

Role: primary

Nicolas Mathieu, MS

Role: primary

Annick Bonvin

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38570773 (View on PubMed)

Mittaz 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.

Reference Type DERIVED
PMID: 30642252 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CER-00931

Identifier Type: -

Identifier Source: org_study_id