Accidental Falls, Aging, Health Behavior
Conditions
Keywords
Postural Balance, Cost-Benefit Analysis, Morbidity, Exercise
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.
Interventions
BEHAVIORALSupervised physical exercise
Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.
OTHERHealth counselling
Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.
Sponsors
University of Eastern Finland
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
75 Years to 84 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of fall | 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. |
| Risk of falls | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause morbidity | two years | Methods of assessment; Use of national health care registries and hospital discharge registries. Outcome: Validated morbidity during follow up. |
| Functional capacity | 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). |
| Range of motion | 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). |
| Postural Balance | 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). |
| Bone mineral density | two years | Method of assessment; Dual X-ray Absorption (DXA) measurement in proximal femur. Outcomes; Areal bone mineral density (g/cm2). |
| Body composition | two years | Method of assessment; Dual X-ray Absorption (DXA) total body scan. Outcomes; body soft tissue and bone mass distribution (g). |
| Grip strength | two years | Methods of assessment; Maximal grip strength by using handheld dynamometer. Outcomes; Maximal muscle force produced (kg). |
| Muscle strength and balance | 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). |
| Depression | two years | Methods of assessment; Geriatric Depression Scale (GDS). Outcomes: Units on a Scale |
| Life satisfaction | two years | Methods of assessment; Life satisfaction scale (LS). Outcomes: Units on a Scale |
| Psychological stress | two years | Methods of assessment; Perceived Stress Scale (PSS). Outcomes: Units on a Scale. |
| Psychological stress coping | two years | Methods of assessment; Brief Resilience Coping Scale (BRCS). Outcomes: Units on a Scale. |
| Life orientation | two years | Methods of assessment; Life Orientation Test (LOT-R) questionnaire Outcomes: Units on a Scale. |
| health-related quality of life (HRQoL) | two years | Methods of assessment; 15-D self administered measure scale Outcomes: Units on a Scale. |
| Self perceived quality of life | two years | Methods of assessment; World Health Organization WHOQOL-BREF. Outcomes: Units on a Scale. |
| Leg muscle strength | two years | Methods of assessment; isometric leg extension strength in a sitting position with a force plate device. Outcomes; Maximal muscle force produced (kg). |
| Morbidity | two years | Methods of assessment; Self reported health survey concerning chronic medical conditions. Outcome: Morbidity during follow up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Life style habits | two years | Self reported history of health behaviour by using OSTPRE study follow up data registry. Post hoc. Outcomes: Units on a scale. |
| Use of healthcare services | 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) |
Countries
Finland
Outcome results
None listed