Kuopio Fall Prevention Study.

Study Overview
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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.

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

Conditions
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Accidental Falls, Health Behavior, Aging

Intervention / Treatment
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* Behavioral: Supervised physical exercise
* Other: Health counselling


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postural Balance, Cost-Benefit Analysis, Morbidity, Exercise