An interventional study of Home-based physiotherapy (physical exercise) in Frail Elderly and Hip Fracture, sponsored by South Karelia, Social and Health Care District. Completed at 1 site in Finland. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by South Karelia, Social and Health Care District · Not applicable, Interventional, and Supportive care
Our objective is to study the effects of 12 months' intensive home-based physiotherapy (physical exercise) with 12 months' follow-up in two groups of older people: 1) those with an operated hip fracture (60+ y), and 2) those with signs of frailty (65+ y). The primary outcome measure is duration of living at home. Power calculations are based on the assumption that persons assigned to physiotherapy will live at home for six months longer vs. those in usual care. Secondary outcomes are physical functioning, falls, health-related quality-of-life, use and costs of social and health services, and mortality.
We will recruit 300 persons with hip fracture and 300 with signs of frailty in Eksote (South Karelia Social and Health Care District), Finland (population 133 000). The groups will be randomized separately into an intervention arm (home-based physiotherapy (physical exercise) twice a week for 12 months) and a control arm (usual care), resulting in 150 patients in each group.
An assessor-physiotherapist and assessor-nurse performs measurements at the participant's home at baseline, and after 3, 6 and 12 months. Assessments include, among others, Fried's frailty criteria, Short Physical Performance Battery (SPPB), Functional Independence Measure (FIM), Health-related quality-of-life (HRQoL, 15-D), Mini Nutritional Assessment (MNA), Falls Efficacy Scale - International (FES-I), Social Provision Scale (SPS), Mini Mental State Examination (MMSE), and Geriatric Depression Scale-15 (GDS-15). At 24 months we collect register information on mortality and the usage of health care services.
Recruitment will begin in December 2014 and last for three years. Data analyses and reporting will take place in 2017-21. The study is supported by the Social Insurance Institution of Finland, and the Ministry of Social Affairs and Health, Finland.
There is increasing need to develop new models of rehabilitation to postpone older people's disabilities and institutional care. One alternative is home-based rehabilitation with emphasis on functional-based exercises and nutrition.
Our objective is to study the effects of home-based physiotherapy (physical exercise) for 12 months followed by 12 months' follow-up in older people, either with an operated hip fracture (60+ y) or with signs of frailty (65+ y). The primary outcome measure is duration of living at home (vs. assisted living and institutional care). Power calculations are based on the assumption that at 24 months persons assigned to physiotherapy (physical exercise) have lived at home for six months longer vs. those in usual care. Usual care follows the standard care procedures in South Karelia social and health care district (Eksote), Finland. The population in Eksote area is 133, 000. Secondary outcomes are physical functioning, falls, health-related quality-of-life (HRQoL), use and costs of social and health services, and mortality.
We will recruit 300 persons with hip fracture and 300 with signs of frailty. After the operation, persons with hip fracture will be transferred from the surgery unit to a rehabilitation hospital, where spend approximately four weeks before discharge. The other patient group includes persons with frailty signs. They will be screened among outpatients and inpatients using modified frailty questionnaires by Abellan van Kan et al. (2008) and Morley et al. (2012). Diagnosis of frailty is based on Fried´s criteria (2001). Both patient groups will be randomized separately into an intervention arm (home-based physiotherapy (physical exercise) twice a week for 12 months) and a control arm (usual care), resulting in 150 patients in each group.
Physiotherapy (physical exercise) is carried out by private physiotherapists, who have been trained to follow the intervention protocol. Physiotherapy (physical exercise) is individually designed to meet the patient's functional capacity and needs but at the same time it is progressive. Each physiotherapy (physical exercise) session includes muscle strength and endurance training (especially for lower limbs), balance and coordination training and functional training. Functional training includes activities of daily living (ADL) and walking exercises. In addition, the physiotherapists give counseling on nutrition (based on Mini Nutritional Assessment, MNA) and follow the participant´s weight.
An assessor-physiotherapist and assessor-nurse performs measurements at the participant's home at baseline, and after 3, 6 and 12 months. Assessments include, among others, modified Fried's frailty criteria, Short Physical Performance Battery (SPPB), Functional Independence Measure (FIM), HRQoL (15 D), MNA, Falls Efficacy Scale - International (FES-I), Social Provision Scale (SPS), Mini Mental State Examination (MMSE), and Geriatric Depression Scale-15 (GDS-15). In addition we collect register data on living and housing conditions, use and costs of social and health care services, and mortality at the end of the follow-up (24 months since the beginning of the study).
Recruitment will begin in December 2014 and last for three years. Data analyses and reporting will take place in 2017-21. The study is supported by the Social Insurance Institution of Finland, and the Ministry of Social Affairs and Health, Finland.
References
1,199 studies on the registry are indexed under Frailty; 429 are open to participants now.
This study's enrollment of 421 is above the median of 80 across 680 interventional studies indexed under Frailty.
Browse Frailty studies →South Karelia, Social and Health Care District is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individually tailored, long-term home-based physiotherapy (physical exercise)twice a week for 12 months. The duration of one session is 60 minutes.
Other: Home-based physiotherapy (physical exercise)
Individually tailored, long-term home-based physiotherapy (physical exercise)twice a week for 12 months. The duration of one session is 60 minutes.
Other: Home-based physiotherapy (physical exercise)
Usual care follows the standard care procedures in the South Karelia Social and Health Care District in health care and in assisted home living.
Usual care follows the standard care procedures in the South Karelia Social and Health Care District in health care and in assisted home living.
Each physiotherapy (physical exercise) session includes muscle strength and endurance training (especially for lower limbs), balance and coordination training and functional training. Functional training includes walking exercises and ADL (activities of daily living) exercises. In addition the physiotherapist gives counseling on nutrition.
duration of time living at home
register information
Time frame: 24 months
change in physical functioning
Short Physical Performance Battery, Hand grip strength, Functional Independence Measure, Instrumental Activities of Daily Living, physical activity
Time frame: baseline and 3, 6, 12 months
the amount of use of social and health services
register information, the amount of primary and secondary healthcare and social services used during study period (two years) gathered from the electronic medical records
Time frame: baseline and 12 and 24 months
the cost of the social and health services used
register information, the amount of services calculated by multiplying the number of service units used with the national mean unit costs
Time frame: baseline and 12 and 24 months
change in health-related quality-of-life
15D© which has fifteen items, each having five answer options, A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale (1=full health, 0=death).
Time frame: baseline and 3, 6, 12 months
change in severity of frailty
modified Fried´s frailty criteria
Time frame: baseline and 12 months
all cause mortality
register information
Time frame: 3, 6, 12 and 24 months
the amount of falls
diary, register information
Time frame: baseline and 3, 6, 12 months
Plan to share: No — This was not planned in advance in the original study plan. We do not have participants permission to share our data.
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South Karelia, Social and Health Care District