Falls Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Participants are randomly allocated to one of two groups:
Current interventions as of 04/01/2019:
Control group: Participants will receive a sham exercise intervention
Sponsors
University of Jyväskylä
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 04/02/2019: 1. Aged 65 years or over 2. Community-living people 3. Living in Ylöjärvi, Finland, or neighbouring municipalities 4. At least minor mobility difficulty 5. Living in Pirkanmaa distrcit. Previous participant inclusion criteria as of 30/08/2016 1. Aged 65 years or over 2. Community-living people 3. Living in Ylöjärvi, Finland, or neighbouring municipalities 4. At least minor mobility difficulty Previous participant inclusion criteria: 1. Aged 65 years or over 2. Community-living people 3. Living in Ylöjärvi, Finland, or neighbouring municipalities 4. At least minor mobility difficulty 5. History of fall(s)
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 30/08/2016 1. Severe functional limitations (unable to walk 500 m unaided) 2. Severe cardiovascular or pulmonary disease 3. Severe progressive disease 4. Terminally ill (predicted lifetime <12 months) 5. Memory impairment (MMSE score 21 points or less) 6. Living in an institution 7. Unwilling to be randomized 8. Alcoholism (AUDIT score = 15) Previous participant exclusion criteria: 1. Severe functional limitations (unable to walk 500 m unaided) 2. Severe cardiovascular or pulmonary disease 3. Severe progressive disease 4. Terminally ill (predicted lifetime <12 months) 5. Memory impairment (MMSE score 21 points or less) 6. Living in an institution 7. Unwilling to be randomized
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 04/02/2019: 1. Life-space mobility assessed by a validated questionnaire (Life-spece mobility measures mobility based on distance through which a person reports moving during the 4 weeks preceding the assessment. Questions establish movement to specific life-space levels ranging from within one’s dwelling to beyond one’s town) at baseline, 12, 24 and 48 months. 2. Falls rates: daily filled and monthly returned fall-diaries will be used to collect information on falls and fall-related injuries and registers will be used to verify severe injuries at baseline, 12, 24 and 48 months. Previous primary outcome measures: 1. Life-space mobility assessed by a validated questionnaire (Life-spece mobility measures mobility based on distance through which a person reports moving during the 4 weeks preceding the assessment. Questions establish movement to specific life-space levels ranging from within one’s dwelling to beyond one’s town) at baseline, 12, 24 and 48 months 2. Number of falls and fall-related injuries: monthly collected fall-diaries will be used to collect information on falls and fall-related injuries and registers will be used to verify severe injuries at baseline, 12, 24 and 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/02/2019: 1. Physical activity is assessed using a Finnish Hookie AM 20 triaxial accelerometer for 7 days and physical activity diary for 4 weeks at baseline, 12, 24 and 48 months. 2. Physical performance is measured using the Timed Up and Go-test (TUG), Short Physical Performance Battery (SPPB) and Jamar hand dynamometer at baseline, 12, 24 and 48 months. 3. Number of fallers (a fall indicator variable: yes/no) will be assessed based on diaries filled daily and returned each month until 24-months after the baseline. 4. Fall-induced injuries will be assessed based on diaries filled daily and returned each month until 24-months after the baseline. 5. Health-related quality of life is assessed using The World Health Organization Quality of Life (WHOQoL) questionnaire at baseline, 12, 24 and 48 months. 6. Living arrangements are determined by asking patients at baseline, 12, 24 and 48 months. 7. Fracture risk is assessed using the WHO Fracture Risk Assessment Tool at baseline, 12, 24 and 48 months. 8. Depressive mood is assessed using the Geriatric Depression Scale (GDS-15) at baseline, 12, 24 and 48 months. 9. Cognitive status is assessed using the Mini-Mental State Examination (MMSE) at baseline, 12, 24 and 48 months. 10. Balance confidence is assessed using the Activities-specific Balance Confidence scale (ABC) at baseline, 12, 24 and 48 months. 11. Fear of falling is assessed (yes/no) and measured by the Visual Analogue Scale (VAS),[40]. A 100-mm long line will be used with the left end of the line (0?mm) representing “no fear” and the right end (100?mm) “extreme fear”. Previous secondary outcome measures as of 04/05/2018: 1. Physical activity is assessed using a Finnish Hookie AM 20 triaxial accelerometer for 7 days | — |
Countries
Finland
Contacts
Public ContactJohanna Edgren
Outcome results
None listed