Effects of Long-term Intensive Home-based Physiotherapy on Older People With an Operated Hip Fracture or Frailty (RCT).

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. (2008). The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging.12(1):29-37 Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA. (2001). Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci;56(3):M146-56. Morley JE, Malmstrom TK, Miller DK.(2012). A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging 16(7):601-8.

Official Title
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Effects of Long-term Intensive Home-based Physiotherapy on Older People With an Operated Hip Fracture or Frailty (RCT).

Conditions
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Frail Elderly, Hip Fracture

Intervention / Treatment
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* Other: Home-based physiotherapy (physical exercise)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 65+ for frail persons and 60 + for hip fracture patients home-dwelling but an increased risk for disabilities or for institutional care ability to walk inside one´s own home with or without mobility aids ability to communicate in Finnish in case of hip fracture: the first operated hip fracture in case of frailty: signs of frailty assessed by modified Fried's frailty criteria Exclusion Criteria: living in nursing home or institutional care facility severe neurological diseases (Parkinson, MS, stroke) severe heart diseases with physical capacities significantly impaired (NYHA class III or IV) severe musculoskeletal diseases which prevent from participating in long-term physiotherapy terminal illnesses (e.g. cancer) that diminish the estimated home-dwelling time to less than two years severe mental problems (severe depression, psychosis or schizophrenia) severe alcohol or drug abuse severe problems with hearing or eyesight

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy (physical exercise) for frail elderly<br>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)<br>* 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.<br>|
| Experimental: Physiotherapy (physical exercise) for operated hip fracture patients<br>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)<br>* 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.<br>|
| No Intervention: Usual care for frail elderly<br>Usual care follows the standard care procedures in the South Karelia Social and Health Care District in health care and in assisted home living. | |
| No Intervention: Usual care for operated hip fracture patients<br>Usual care follows the standard care procedures in the South Karelia Social and Health Care District in health care and in assisted home living. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of time living at home | register information | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in physical functioning | Short Physical Performance Battery, Hand grip strength, Functional Independence Measure, Instrumental Activities of Daily Living, physical activity | 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 | 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 | 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). | baseline and 3, 6, 12 months | 
| change in severity of frailty | modified Fried´s frailty criteria | baseline and 12 months | 
| all cause mortality | register information | 3, 6, 12 and 24 months | 
| the amount of falls | diary, register information | baseline and 3, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home-dwelling, elderly, functional-based physiotherapy, frailty syndrome, osteoporotic hip fractures, home-based physiotherapy, intervention, randomised controlled trial, costs of social and health care, quality of life, physical functioning, mobility, nutrition