Clinical trial NCT02665169: Kuopio Fall Prevention Study.
Official title: Randomized Fall Prevention Trial For Aging Females by Providing Supervised Exercises and Free Use of Municipal Recreation Facilities.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Health Behavior
Aging
Keywords: Postural Balance
Cost-Benefit Analysis
Morbidity
Exercise
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2016-01-27
Enrollment: 914
Sex: FEMALE
Minimum age (years): 75
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Risk of falls
timeFrame: Two years
measure: Risk of fall
timeFrame: Two years
Secondary outcomes:
measure: Morbidity
timeFrame: two years
measure: All cause morbidity
timeFrame: two years
measure: Functional capacity
timeFrame: two years
measure: Range of motion
timeFrame: two years
measure: Postural Balance
timeFrame: two years
measure: Bone mineral density
timeFrame: two years
measure: Body composition
timeFrame: two years
measure: Grip strength
timeFrame: two years
measure: Leg muscle strength
timeFrame: two years
measure: Muscle strength and balance
timeFrame: two years
measure: Depression
timeFrame: two years
measure: Life satisfaction
timeFrame: two years
measure: Psychological stress
timeFrame: two years
measure: Psychological stress coping
timeFrame: two years
measure: Life orientation
timeFrame: two years
measure: health-related quality of life (HRQoL)
timeFrame: two years
measure: Self perceived quality of life
timeFrame: two years
Other outcomes:
measure: Life style habits
timeFrame: two years
measure: Use of healthcare services
timeFrame: two years
Locations:
city: Kuopio
country: Finland
facility: Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio
Study officials:
affiliation: Department of Surgery, Kuopio University Hospital
name: Heikki Kröger, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuopio Musculoskeletal Research Unit, University of Eastern Finland
name: Toni Rikkonen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.