Kuopio Fall Prevention Study. (KFPS)

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.

Study Overview

• Status: Completed
• Conditions: Aging; Health Behavior; Accidental Falls
• Intervention / Treatment: Behavioral: Supervised physical exercise; Other: Health counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 914
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70211
    • Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 84 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Supervised physical exercise; Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.; Other: Health counselling; Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.
Active Comparator: Control group; Control group, without any induced exercise intervention. Written and oral health counselling provided.	Other: Health counselling; Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Methods of assessment; Self reported health survey concerning chronic medical conditions. Outcome: Morbidity during follow up.	two years
All cause morbidity	Methods of assessment; Use of national health care registries and hospital discharge registries. Outcome: Validated morbidity during follow up.	two years
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).	two years
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).	two years
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).	two years
Bone mineral density	Method of assessment; Dual X-ray Absorption (DXA) measurement in proximal femur. Outcomes; Areal bone mineral density (g/cm2).	two years
Body composition	Method of assessment; Dual X-ray Absorption (DXA) total body scan. Outcomes; body soft tissue and bone mass distribution (g).	two years
Grip strength	Methods of assessment; Maximal grip strength by using handheld dynamometer. Outcomes; Maximal muscle force produced (kg).	two years
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).	two years
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).	two years
Depression	Methods of assessment; Geriatric Depression Scale (GDS). Outcomes: Units on a Scale	two years
Life satisfaction	Methods of assessment; Life satisfaction scale (LS). Outcomes: Units on a Scale	two years
Psychological stress	Methods of assessment; Perceived Stress Scale (PSS). Outcomes: Units on a Scale.	two years
Psychological stress coping	Methods of assessment; Brief Resilience Coping Scale (BRCS). Outcomes: Units on a Scale.	two years
Life orientation	Methods of assessment; Life Orientation Test (LOT-R) questionnaire Outcomes: Units on a Scale.	two years
health-related quality of life (HRQoL)	Methods of assessment; 15-D self administered measure scale Outcomes: Units on a Scale.	two years
Self perceived quality of life	Methods of assessment; World Health Organization WHOQOL-BREF. Outcomes: Units on a Scale.	two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life style habits	Self reported history of health behaviour by using OSTPRE study follow up data registry. Post hoc. Outcomes: Units on a scale.	two years
Use of healthcare services	Use of health service use during the follow up by utilizing hospital discharge registries. Outcome: Resources spent in healthcare during follow up(Euros)	two years

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: University of Eastern Finland
• Investigators: Principal Investigator: Heikki Kröger, Professor, Department of Surgery, Kuopio University Hospital; Principal Investigator: Toni Rikkonen, Dr, Kuopio Musculoskeletal Research Unit, University of Eastern Finland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Cost-Benefit Analysis; Morbidity; Postural Balance
• Other Study ID Numbers: KUH5203083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO