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Accidental FallsKFPSNCT02665169

Kuopio Fall Prevention Study.

A study testing Supervised physical exercise and Health counselling in people with Accidental Falls and Health Behavior, run by Kuopio University Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 75 to 84 years, women only
Conditions the study is for
Accidental Falls, Health Behavior, Aging
What is being tested?
Supervised physical exercise and Health counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
914 participants
Where
1 siteFinland
Study dates
Mar 2016to Jun 2019
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 75 to 84 years
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • Unstable angina pectoris, severe pulmonary disease, not self-ambulatory or institutionalized, moderate to severe dementia.

Trial locations and contacts

1 site in 1 country.

Finland1 site

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

    Kuopio, 70211

Other trials in Finland

About this study

Official title: Randomized Fall Prevention Trial For Aging Females by Providing Supervised Exercises and Free Use of Municipal Recreation Facilities.

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.

Read the detailed description

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.

Being tested
Supervised physical exercise, Health counselling
Keywords
Postural Balance, Cost-Benefit Analysis, Morbidity, Exercise
Medical subject headings
Health Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised physical exerciseBehavioural

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

  • Health counsellingOther

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

Study groups in NCT02665169
Study groupRoleWhat they receive
Exercise intervention groupExperimentalSupervised 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.
Receives: Behavioral: Supervised physical exercise; Other: Health counselling
Control groupActive comparatorControl group, without any induced exercise intervention. Written and oral health counselling provided.
Receives: Other: Health counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk of falls

    Method of assessment; Personal fall diary. In case of fall, subject records the event into logbook. Outcome: Number of Falls during follow up.

    Measured: Two years

  2. Risk of fall

    Biweekly text message (SMS) question concerning recent falls during last 2 weeks (Reply:Yes/No). In a case of a positive reply, following phone call to the subject to validate the event. Outcome: Number of Falls during follow up.

    Measured: Two years

Secondary outcomes (17)

  1. Morbidity

    Methods of assessment; Self reported health survey concerning chronic medical conditions. Outcome: Morbidity during follow up.

    Measured: two years

  2. All cause morbidity

    Methods of assessment; Use of national health care registries and hospital discharge registries. Outcome: Validated morbidity during follow up.

    Measured: two years

  3. Functional capacity

    Methods of assessment; Timed Get Up and Go Test (TUG). Outcomes; Time consumed the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. Outcome: Time consumed in the task (Seconds).

    Measured: two years

  4. Range of motion

    Methods of assessment; Squatting test. Outcomes; Physical task to squat down, touch the floor with fingertips and get up, without additional support. Outcome: Able/unable to comply (Y/N).

    Measured: two years

  5. Postural Balance

    Methods of assessment; One leg stand test. Outcomes; Able to maintain static one leg standing position for ten second (Seconds), Outcome: able/unable to comply (Y/N).

    Measured: two years

  6. Bone mineral density

    Method of assessment; Dual X-ray Absorption (DXA) measurement in proximal femur. Outcomes; Areal bone mineral density (g/cm2).

    Measured: two years

  7. Body composition

    Method of assessment; Dual X-ray Absorption (DXA) total body scan. Outcomes; body soft tissue and bone mass distribution (g).

    Measured: two years

  8. Grip strength

    Methods of assessment; Maximal grip strength by using handheld dynamometer. Outcomes; Maximal muscle force produced (kg).

    Measured: two years

  9. Leg muscle strength

    Methods of assessment; isometric leg extension strength in a sitting position with a force plate device. Outcomes; Maximal muscle force produced (kg).

    Measured: two years

  10. Muscle strength and balance

    Methods of assessment; Balance test protocol by using force plate to measure body sway in various positions. Outcomes; velocity and distance of travel by the center of gravity (mm/second).

    Measured: two years

  11. Depression

    Methods of assessment; Geriatric Depression Scale (GDS). Outcomes: Units on a Scale

    Measured: two years

  12. Life satisfaction

    Methods of assessment; Life satisfaction scale (LS). Outcomes: Units on a Scale

    Measured: two years

  13. Psychological stress

    Methods of assessment; Perceived Stress Scale (PSS). Outcomes: Units on a Scale.

    Measured: two years

  14. Psychological stress coping

    Methods of assessment; Brief Resilience Coping Scale (BRCS). Outcomes: Units on a Scale.

    Measured: two years

  15. Life orientation

    Methods of assessment; Life Orientation Test (LOT-R) questionnaire Outcomes: Units on a Scale.

    Measured: two years

  16. health-related quality of life (HRQoL)

    Methods of assessment; 15-D self administered measure scale Outcomes: Units on a Scale.

    Measured: two years

  17. Self perceived quality of life

    Methods of assessment; World Health Organization WHOQOL-BREF. Outcomes: Units on a Scale.

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion30 May 2019
  4. Study completionJun 2019

Resources

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
914 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02665169
Sponsor's protocol ID
KUH5203083
Acronym
KFPS
Status last verified
Aug 2019
First submitted
11 Jan 2016
Last updated
20 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39972017

  • 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.

    PubMed 37145268

  • 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.

    PubMed 34487834

  • 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.

    PubMed 31230026

Questions about this trial

What is this clinical trial studying?

A study testing Supervised physical exercise and Health counselling in people with Accidental Falls and Health Behavior, run by Kuopio University Hospital at 1 site in Finland.

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 1 inclusion and 1 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 20 Aug 2019. 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 Finland. 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?

Risk of falls (time frame: Two years). The study lists 2 primary outcomes in all. 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 NCT02665169, which also lists 4 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 20 Aug 2019.

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