NCT02665169

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
914

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

January 11, 2016

Last Update Submit

August 16, 2019

Conditions

Keywords

Postural BalanceCost-Benefit AnalysisMorbidityExercise

Outcome Measures

Primary Outcomes (2)

  • 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.

    Two years

  • 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.

    Two years

Secondary Outcomes (17)

  • Morbidity

    two years

  • All cause morbidity

    two years

  • Functional capacity

    two years

  • Range of motion

    two years

  • Postural Balance

    two years

  • +12 more secondary outcomes

Other Outcomes (2)

  • Life style habits

    two years

  • Use of healthcare services

    two years

Study Arms (2)

Exercise intervention group

EXPERIMENTAL

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.

Behavioral: Supervised physical exerciseOther: Health counselling

Control group

ACTIVE COMPARATOR

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

Other: Health counselling

Interventions

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

Exercise intervention group

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

Control groupExercise intervention group

Eligibility Criteria

Age75 Years - 84 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kuopio, 70211, Finland

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Heikki Kröger, Professor

    Department of Surgery, Kuopio University Hospital

    PRINCIPAL INVESTIGATOR
  • Toni Rikkonen, Dr

    Kuopio Musculoskeletal Research Unit, University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 27, 2016

Study Start

March 1, 2016

Primary Completion

May 30, 2019

Study Completion

June 1, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations