NCT02305433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
421

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

8.1 years

First QC Date

November 28, 2014

Last Update Submit

February 20, 2023

Conditions

Frail ElderlyHip Fracture

Keywords

elderlyfunctional-based physiotherapyfrailty syndromeosteoporotic hip fractureshome-based physiotherapyhome-dwellinginterventionrandomised controlled trialcosts of social and health carequality of lifephysical functioningmobilitynutrition

Outcome Measures

Primary Outcomes (1)

  • duration of time living at home

    register information

    24 months

Secondary Outcomes (7)

  • change in physical functioning

    baseline and 3, 6, 12 months

  • the amount of use of social and health services

    baseline and 12 and 24 months

  • the cost of the social and health services used

    baseline and 12 and 24 months

  • change in health-related quality-of-life

    baseline and 3, 6, 12 months

  • change in severity of frailty

    baseline and 12 months

  • +2 more secondary outcomes

Study Arms (4)

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.

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.

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.

Interventions

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.

Physiotherapy (physical exercise) for frail elderlyPhysiotherapy (physical exercise) for operated hip fracture patients

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Karelia Social and Health Care District

Lappeenranta, South Karelia Region, Finland

Location

Related Publications (9)

  • 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.

    PMID: 30285645BACKGROUND

  • 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 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.

    PMID: 33939973RESULT

  • 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. 2022 Sep;70(9):2561-2570. doi: 10.1111/jgs.17824. Epub 2022 May 18.

    PMID: 35582993RESULT

  • 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):1419-1427. doi: 10.1007/s40520-019-01180-z. Epub 2019 Apr 2.

    PMID: 30941731RESULT

  • 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 Trial. J Am Med Dir Assoc. 2021 Apr;22(4):773-779. doi: 10.1016/j.jamda.2020.06.005. Epub 2020 Jul 18.

    PMID: 32694001RESULT

  • 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. Arch Phys Med Rehabil. 2021 Dec;102(12):2283-2290. doi: 10.1016/j.apmr.2021.06.017. Epub 2021 Jul 18.

    PMID: 34283997RESULT

  • 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. 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.

    PMID: 35985418RESULT

  • Suikkanen 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.

    PMID: 41130912DERIVED

  • Fairhall 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.

    PMID: 36070134DERIVED

Related Links

MeSH Terms

Conditions

Hip FracturesFrailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Markku T Hupli, MD, PhD

    Treenix

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 2, 2014

Study Start

December 1, 2014

Primary Completion

December 31, 2022

Study Completion

February 20, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

This was not planned in advance in the original study plan. We do not have participants permission to share our data.

Locations

FI(1)