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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 March 2023
• Main ID: NCT02305433
• Date of registration: 28/11/2014
• Prospective Registration: Yes
• Primary sponsor: South Karelia, Social and Health Care District
• Public title: Effects of Long-term Intensive Home-based Physiotherapy on Older People With an Operated Hip Fracture or Frailty (RCT). HIPFRA
• Scientific title: Effects of Long-term Intensive Home-based Physiotherapy on Older People With an Operated Hip Fracture or Frailty (RCT).
• Date of first enrolment: December 2014
• Target sample size: 421
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02305433
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Markku T Hupli, MD, PhD
• Affiliation: Treenix

Key inclusion & exclusion criteria

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



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hip Fracture

Frail Elderly

Intervention(s)

Other: Home-based physiotherapy (physical exercise)

Primary Outcome(s)

duration of time living at home [Time Frame: 24 months]

Secondary Outcome(s)

change in physical functioning [Time Frame: baseline and 3, 6, 12 months]

the amount of use of social and health services [Time Frame: baseline and 12 and 24 months]

change in severity of frailty [Time Frame: baseline and 12 months]

change in health-related quality-of-life [Time Frame: baseline and 3, 6, 12 months]

all cause mortality [Time Frame: 3, 6, 12 and 24 months]

the amount of falls [Time Frame: baseline and 3, 6, 12 months]

the cost of the social and health services used [Time Frame: baseline and 12 and 24 months]

Secondary ID(s)

1236/00.01.05.01.00/2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Jyvaskyla

University of Helsinki

University of Eastern Finland

Social Insurance Institution, Finland

Ministry of Social Affairs and Health; Finland

University of Poitiers