Kuopio Fall Prevention Study.

Aging Clinical Trial

— KFPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665169
• Other study ID #: KUH5203083
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: June 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Falls
• Aging
• Health Behavior

Intervention

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.

Locations

Country	Name	City	State
Finland	Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

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