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

Hip Fracture Clinical Trial

— HIPFRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305433
• Other study ID #: 1236/00.01.05.01.00/2013
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2023
• Source: South Karelia, Social and Health Care District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: February 20, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Frail Elderly
• Frailty
• Hip Fracture
• Hip Fractures

Intervention

Other:
• Home-based physiotherapy (physical exercise)
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.

Locations

Country	Name	City	State
Finland	South Karelia Social and Health Care District	Lappeenranta	South Karelia

Sponsors (7)

Lead Sponsor	Collaborator
South Karelia, Social and Health Care District	Ministry of Social Affairs and Health; Finland, Social Insurance Institution, Finland, University of Eastern Finland, University of Helsinki, University of Jyvaskyla, University of Poitiers

Country where clinical trial is conducted

Finland, 

References & Publications (7)

Soukkio P, Suikkanen S, Kaaria S, Kautiainen H, Sipila S, Kukkonen-Harjula K, Hupli M. Effects of 12-month home-based physiotherapy on duration of living at home and functional capacity among older persons with signs of frailty or with a recent hip fracture - protocol of a randomized controlled trial (HIPFRA study). BMC Geriatr. 2018 Oct 1;18(1):232. doi: 10.1186/s12877-018-0916-y. — View Citation

Soukkio PK, Suikkanen SA, Aartolahti EM, Kautiainen H, Kaaria SM, Hupli MT, Pitkala KH, Sipila S, Kukkonen-Harjula KT. Effects of Home-Based Physical Exercise on Days at Home, Health Care Utilization, and Functional Independence Among Patients With Hip Fr — View Citation

Soukkio PK, Suikkanen SA, Kukkonen-Harjula KT, Kautiainen H, Hupli MT, Aartolahti EM, Kaaria SM, Pitkala KH, Sipila S. Effects of a 12-month home-based exercise program on functioning after hip fracture - Secondary analyses of an RCT. J Am Geriatr Soc. 20 — View Citation

Suikkanen S, Soukkio P, Aartolahti E, Kaaria S, Kautiainen H, Hupli MT, Pitkala K, Sipila S, Kukkonen-Harjula K. Effect of 12-Month Supervised, Home-Based Physical Exercise on Functioning Among Persons With Signs of Frailty: A Randomized Controlled Trial. — View Citation

Suikkanen S, Soukkio P, Kautiainen H, Kaaria S, Hupli MT, Sipila S, Pitkala K, Aartolahti E, Kukkonen-Harjula K. Changes in the Severity of Frailty Among Older Adults After 12 Months of Supervised Home-Based Physical Exercise: A Randomized Clinical Trial. — View Citation

Suikkanen S, Soukkio P, Pitkala K, Kaaria S, Kautiainen H, Sipila S, Kukkonen-Harjula K, Hupli M. Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. Aging Clin Exp Res. 2019 Oct;31(10):1 — View Citation

Suikkanen SA, Soukkio PK, Aartolahti EM, Kautiainen H, Kaaria SM, Hupli MT, Sipila S, Pitkala KH, Kukkonen-Harjula KT. Effects of Home-Based Physical Exercise on Days at Home and Cost-Effectiveness in Pre-Frail and Frail Persons: Randomized Controlled Tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of time living at home	register information	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	change in severity of frailty	modified Fried´s frailty criteria	baseline and 12 months
Secondary	all cause mortality	register information	3, 6, 12 and 24 months
Secondary	the amount of falls	diary, register information	baseline and 3, 6, 12 months

External Links

•   PhD thesis, Sara Suikkanen: Home-Based Physical Exercise Among Older Adults with Signs of Frailty - Emphasis on Days Lived at Home, Utilization of Social and Health Care Services, Quality of Life, Physical Functioning, and Severity of Frailty
•   The study protocol and details of the intervention and participating in the intervntion in Finnish.
•   The study report of the results of other secondary outcomes in Finnish.