Kuopio Fall Prevention Study.

NCT ID: NCT02665169

Last Updated: 2019-08-20

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

914 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-06-30

Brief Summary

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This study evaluates the 6 month exercise intervention (Taiji and gym course) combined with free use of communal recreation facilities in fall prevention.

Morbidity, use of social services and health outcomes of aging women in province of Kuopio, Finland are also monitored. The study combines a six months supervised exercise, followed by six months free, but unsupervised, use of recreational facilities and observational period of second year into total of 2 year follow up duration.

Detailed Description

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In 2016, a 2-year randomized controlled trial (RCT) will be launched to investigate the effect of exercise on fall risk, injuries and subjective well-being (SWB) in aging women (n=1078) by using municipal sport services in cooperation with the city of Kuopio. The effect of the exercise intervention on functional capacity, muscle strength, bone, body composition, cognitive function, the use of health services and its cost effectiveness will also be studied.

The trial will be carried out on women belonging to the Kuopio Osteoporosis Risk Factor and Prevention (OSTPRE) Study, which is an ongoing population-based prospective cohort study, with a follow-up of 26 years. It investigates life style factors associated with fractures falls, bone mineral density and morbidity in a target population of 14 220 women, now aged between 75-84 year.

The study combines combination of a 2-year fall prevention trial with the 26 years of life style and medical data from the previous OSTPRE follow up to provide meaningful answers whether municipal exercise program can provide cost effective health gain in elderly. In addition, the study aims to answer, who will benefit from the exercise the most and what are the underlying factors explaining efficacy in the women's previous 26 years of lifestyle and medical history. The study will help to develop strategies for societal fall prevention.

Conditions

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Accidental Falls Health Behavior Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise intervention group

Supervised exercise intervention of 12 months. One Taiji and one gym training per week for first six months followed by 6 months free independent use of municipal facilities, including gym, swimming hall and weight room. Written and oral health counselling provided.

Group Type EXPERIMENTAL

Supervised physical exercise

Intervention Type BEHAVIORAL

Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.

Health counselling

Intervention Type OTHER

Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.

Control group

Control group, without any induced exercise intervention. Written and oral health counselling provided.

Group Type ACTIVE_COMPARATOR

Health counselling

Intervention Type OTHER

Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.

Interventions

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Supervised physical exercise

Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.

Intervention Type BEHAVIORAL

Health counselling

Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Included in the previous Osteoprosis Risk Factors and Prevention (OSTPRE) study follow up protocol, conducted in Kuopio Finland, between 1989-2015.

Exclusion Criteria

* Unstable angina pectoris, severe pulmonary disease, not self-ambulatory or institutionalized, moderate to severe dementia.
Minimum Eligible Age

75 Years

Maximum Eligible Age

84 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heikki Kröger, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Kuopio University Hospital

Toni Rikkonen, Dr

Role: PRINCIPAL_INVESTIGATOR

Kuopio Musculoskeletal Research Unit, University of Eastern Finland

Locations

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Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Tamminen AE, Honkanen R, Koivumaa-Honkanen H, Sirola J, Sund R, Kroger H, Rikkonen T. Exercise reduces the risk of falls in women with polypharmacy: secondary analysis of a randomized controlled trial. Sci Rep. 2025 Feb 19;15(1):6009. doi: 10.1038/s41598-025-88205-y.

Reference Type DERIVED
PMID: 39972017 (View on PubMed)

Vilpunaho T, Karinkanta S, Sievanen H, Kopra J, Kroger H, Rikkonen T. Predictive ability of a self-rated fall risk assessment tool in community-dwelling older women. Aging Clin Exp Res. 2023 Jun;35(6):1205-1212. doi: 10.1007/s40520-023-02423-w. Epub 2023 May 5.

Reference Type DERIVED
PMID: 37145268 (View on PubMed)

Vilpunaho T, Sund R, Koivumaa-Honkanen H, Honkanen R, Kroger H, Rikkonen T. Urban RCT participants were healthier than non-participants or rural women. J Clin Epidemiol. 2021 Dec;140:44-55. doi: 10.1016/j.jclinepi.2021.08.032. Epub 2021 Sep 3.

Reference Type DERIVED
PMID: 34487834 (View on PubMed)

Vilpunaho T, Kroger H, Honkanen R, Koivumaa-Honkanen H, Sirola J, Kuvaja-Kollner V, Sund R, Rikkonen T. Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS). BMJ Open. 2019 Jun 21;9(6):e028716. doi: 10.1136/bmjopen-2018-028716.

Reference Type DERIVED
PMID: 31230026 (View on PubMed)

Other Identifiers

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KUH5203083

Identifier Type: -

Identifier Source: org_study_id

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