CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 421 enrolled
Drug / intervention
Home-based physiotherapy (physical exercise)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02305433
NCT02305433N/ACompleted

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

South Karelia, Social and Health Care District·interventional·Posted Dec 2, 2014·Updated Feb 22, 2023

In Brief

A clinical study evaluating Home-based physiotherapy (physical exercise) for Frail Elderly and Hip Fracture. Completed, enrolled 421 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 31, 2022
Study CompletionFeb 20, 2023
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 11.6 years ago

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.