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Completed

NCT Number: NCT02665169

Kuopio Fall Prevention Study.

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.

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Key information

Conditions

Accidental Falls Aging Behavior Health Behavior Motor Activity

Age range

75 year–84 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Kuopio, 70211, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised physical exercise

Behavioral

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

Health counselling

Other

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

Primary outcomes

  1. Risk of falls

    Time frame: Two years

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

  2. Risk of fall

    Time frame: Two years

    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.

Secondary outcomes

  1. Morbidity

    Time frame: two years

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

  2. All cause morbidity

    Time frame: two years

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

  3. Functional capacity

    Time frame: two years

    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).

  4. Range of motion

    Time frame: two years

    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).

  5. Postural Balance

    Time frame: two years

    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).

  6. Bone mineral density

    Time frame: two years

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

  7. Body composition

    Time frame: two years

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

  8. Grip strength

    Time frame: two years

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

  9. Leg muscle strength

    Time frame: two years

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

  10. Muscle strength and balance

    Time frame: two years

    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).

  11. Depression

    Time frame: two years

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

  12. Life satisfaction

    Time frame: two years

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

  13. Psychological stress

    Time frame: two years

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

  14. Psychological stress coping

    Time frame: two years

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

  15. Life orientation

    Time frame: two years

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

  16. health-related quality of life (HRQoL)

    Time frame: two years

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

  17. Self perceived quality of life

    Time frame: two years

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

Other outcomes

  1. Life style habits

    Time frame: two years

    Self reported history of health behaviour by using OSTPRE study follow up data registry. Post hoc.

    Outcomes: Units on a scale.

  2. Use of healthcare services

    Time frame: two years

    Use of health service use during the follow up by utilizing hospital discharge registries. Outcome: Resources spent in healthcare during follow up(Euros)

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Eastern Finland

Registry information

Official study title

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

Acronym: KFPS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2016
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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