Frail ElderlyHIPFRANCT02305433
Effects of Long-term Intensive Home-based Physiotherapy on Older People With an Operated Hip Fracture or Frailty (RCT).
A study testing Home-based physiotherapy (physical exercise) in people with Frail Elderly and Hip Fracture, run by South Karelia, Social and Health Care District at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly, Hip Fracture
- What is being tested?
- Home-based physiotherapy (physical exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2014to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
South Karelia Social and Health Care District
Lappeenranta, South Karelia Region
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Frail Elderly, Hip Fracture
- Being tested
- Home-based physiotherapy (physical exercise)
- Keywords
- elderly, functional-based physiotherapy, frailty syndrome, osteoporotic hip fractures, home-based physiotherapy, home-dwelling, intervention, randomised controlled trial, costs of social and health care, quality of life, physical functioning, mobility, nutrition
- Medical subject headings
- Hip Fractures, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based physiotherapy (physical exercise)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy (physical exercise) for frail elderly | Experimental | Individually tailored, long-term home-based physiotherapy (physical exercise)twice a week for 12 months. The duration of one session is 60 minutes. Receives: Other: Home-based physiotherapy (physical exercise) |
| Physiotherapy (physical exercise) for operated hip fracture patients | Experimental | Individually tailored, long-term home-based physiotherapy (physical exercise)twice a week for 12 months. The duration of one session is 60 minutes. Receives: Other: Home-based physiotherapy (physical exercise) |
| Usual care for frail elderly | No intervention | 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 for operated hip fracture patients | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
duration of time living at home
register information
Measured: 24 months
Secondary outcomes (7)
change in physical functioning
Short Physical Performance Battery, Hand grip strength, Functional Independence Measure, Instrumental Activities of Daily Living, physical activity
Measured: 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
Measured: 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
Measured: 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).
Measured: baseline and 3, 6, 12 months
change in severity of frailty
modified Fried´s frailty criteria
Measured: baseline and 12 months
all cause mortality
register information
Measured: 3, 6, 12 and 24 months
the amount of falls
diary, register information
Measured: baseline and 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion31 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Karelia, Social and Health Care District
- Sponsor type
- University, hospital or other
- Collaborators
- Social Insurance Institution, Finland, University of Helsinki, University of Jyvaskyla, University of Eastern Finland, University of Poitiers, Ministry of Social Affairs and Health, Finland
- Responsible party
- Principal investigator, Paula Soukkio, South Karelia, Social and Health Care District
- Investigators
- Markku T Hupli, MD, PhD, Study director, Treenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305433
- Sponsor's protocol ID
- 1236/00.01.05.01.00/2013
- Acronym
- HIPFRA
- Status last verified
- Feb 2023
- First submitted
- 28 Nov 2014
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not planned in advance in the original study plan. We do not have participants permission to share our data.
Publications
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.
PubMed 30285645Soukkio 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 Fractures: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Sep;102(9):1692-1699. doi: 10.1016/j.apmr.2021.04.004. Epub 2021 Apr 30.
PubMed 33939973Soukkio 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. 2022 Sep;70(9):2561-2570. doi: 10.1111/jgs.17824. Epub 2022 May 18.
PubMed 35582993Suikkanen 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):1419-1427. doi: 10.1007/s40520-019-01180-z. Epub 2019 Apr 2.
PubMed 30941731Suikkanen 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 Trial. J Am Med Dir Assoc. 2021 Apr;22(4):773-779. doi: 10.1016/j.jamda.2020.06.005. Epub 2020 Jul 18.
PubMed 32694001Suikkanen 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. Arch Phys Med Rehabil. 2021 Dec;102(12):2283-2290. doi: 10.1016/j.apmr.2021.06.017. Epub 2021 Jul 18.
PubMed 34283997Suikkanen 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. J Am Med Dir Assoc. 2022 Oct;23(10):1717.e9-1717.e15. doi: 10.1016/j.jamda.2022.07.010. Epub 2022 Aug 18.
PubMed 35985418Suikkanen S, Soukkio P, Kantola M, Kautiainen H, Haanpaa M, Hupli MT, Kukkonen-Harjula K. Long-term home-based physical exercise, pain, and use of pain medication over a year after hip fracture - A secondary analysis of a randomised controlled trial. Clin Rehabil. 2026 Feb;40(2):193-206. doi: 10.1177/02692155251389435. Epub 2025 Oct 23.
PubMed 41130912Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
PubMed 36070134
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term Intensive Home-based Physiotherapy on Older People With an Operated Hip Fracture or Frailty (RCT).
- ClinicalTrials.gov ID
- NCT02305433
- Acronym / sponsor ID
- HIPFRA / 1236/00.01.05.01.00/2013
- Conditions
- Frail Elderly, Hip Fracture
- Keywords
- elderly, functional-based physiotherapy, frailty syndrome, osteoporotic hip fractures, home-based physiotherapy, home-dwelling, intervention, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- South Karelia, Social and Health Care DistrictUniversity, hospital or other
- Collaborators
- Social Insurance Institution, Finland, University of Helsinki, University of Jyvaskyla, University of Eastern Finland, University of Poitiers, Ministry of Social Affairs and Health, Finland
- Study start
- Dec 2014
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy (physical exercise) for frail elderly | Experimental | 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. |
| Physiotherapy (physical exercise) for operated hip fracture patients | Experimental | 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. |
| Usual care for frail elderly | No intervention | –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 for operated hip fracture patients | No intervention | –Usual care follows the standard care procedures in the South Karelia Social and Health Care District in health care and in assisted home living. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Physiotherapy (physical exercise) for frail elderly, Physiotherapy (physical exercise) for operated hip fracture patients |
Primary outcome
duration of time living at home
Time frame: 24 months
register information
7 secondary outcomes
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
the cost of the social and health services used
Time frame: baseline and 12 and 24 months
change in health-related quality-of-life
Time frame: baseline and 3, 6, 12 months
change in severity of frailty
Time frame: baseline and 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 30285645Soukkio 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.
- Results publication: PubMed 33939973Soukkio 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 Fractures: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Sep;102(9):1692-1699. doi: 10.1016/j.apmr.2021.04.004. Epub 2021 Apr 30.
- Results publication: PubMed 35582993Soukkio 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. 2022 Sep;70(9):2561-2570. doi: 10.1111/jgs.17824. Epub 2022 May 18.
- Results publication: PubMed 30941731Suikkanen 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):1419-1427. doi: 10.1007/s40520-019-01180-z. Epub 2019 Apr 2.
- Results publication: PubMed 32694001Suikkanen 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 Trial. J Am Med Dir Assoc. 2021 Apr;22(4):773-779. doi: 10.1016/j.jamda.2020.06.005. Epub 2020 Jul 18.
- Results publication: PubMed 34283997Suikkanen 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. Arch Phys Med Rehabil. 2021 Dec;102(12):2283-2290. doi: 10.1016/j.apmr.2021.06.017. Epub 2021 Jul 18.
- Results publication: PubMed 35985418Suikkanen 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. J Am Med Dir Assoc. 2022 Oct;23(10):1717.e9-1717.e15. doi: 10.1016/j.jamda.2022.07.010. Epub 2022 Aug 18.
- Derived from this study: PubMed 41130912Suikkanen S, Soukkio P, Kantola M, Kautiainen H, Haanpaa M, Hupli MT, Kukkonen-Harjula K. Long-term home-based physical exercise, pain, and use of pain medication over a year after hip fracture - A secondary analysis of a randomised controlled trial. Clin Rehabil. 2026 Feb;40(2):193-206. doi: 10.1177/02692155251389435. Epub 2025 Oct 23.
- Derived from this study: PubMed 36070134Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
- The study report of the results of other secondary outcomes in Finnish.Link provided by the sponsor.
- The study protocol and details of the intervention and participating in the intervntion in Finnish.Link provided by the sponsor.
- 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 FrailtyLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markku T Hupli, MD, PhD study director
Treenix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based physiotherapy (physical exercise) in people with Frail Elderly and Hip Fracture, run by South Karelia, Social and Health Care District at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of time living at home (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305433, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.