Home-based Rehabilitation Following a Total Hip Replacement

Completed

• Conditions: Arthroplasty, Replacement, Hip

• Registration Number: NCT03109821
• Lead Sponsor: Central Jutland Regional Hospital

Brief Summary

In this study we will investigate the relation between performed exercise dose and recovery after total hip replacement (THA). A dose-response relationship is hypothesized.

It is the primary objective to indicate the preliminary efficacy of home-based rehabilitation using elastic band exercise on performance-based function after THA, based on the relationship between the performed exercise dose (objectively quantified time under tension summary dose) and the change in 40 meter maximal gait speed (performance-based function) from 3 (start of intervention) to 10 weeks (end of intervention) after surgery.

Detailed Description

The study is a pragmatic, single center, prospective cohort study (single cohort) to be conducted in Silkeborg, Denmark. The outcomes will be collected in the period from 3 to 10 weeks after surgery by an assessor blinded to exercise compliance. The study will adhere methodologically to the STROBE guidelines and checklist for prospective cohort studies (www.strobe-statement.org).

The study design and completion is conducted in a research collaboration between the Interdisciplinary Research Unit at Elective Surgery Centre based at Silkeborg Regional Hospital and Physical Medicine \& Rehabilitation Research - Copenhagen (PMR-C) based at Hvidovre Hospital.

Primary objective, eligibility criteria, exposure/intervention and outcome measures are entered elsewhere. At June 28, 2017, two outcome measures were added to the study. At 10 weeks after surgery, patients will be asked both to describe change in hip problems (from preoperatively to 10 weeks after surgery) and to describe their perception of outcome after surgery. The outcome measures will be used for exploratory analysis of patient acceptable symptom state (PASS) and minimal clinically important improvement (MCII)

Primary analysis:

A simple linear regression analysis will be performed to evaluate the association between performed exercise dose and change in score on gait speed. Furthermore descriptive statistics will be used to quantify exercise compliance and to indicate the exercise dosage with the greatest response. Patients will be divided into four compliance-quartiles and summary statistics of the primary outcome (change in gait speed) will be presented graphically to illustrate possible dose-response relationship.

Secondary analyses:

For change in patient-reported function the analysis will be similar to the analysis for change in gait speed. Summary statistics on the rest of the secondary outcomes will be presented for the compliance-quartiles.

In a multiple regression analysis the association between gait speed (at 10 weeks follow up) and self-efficacy, 24-hour physical activity, performed exercise dose and gait speed (at baseline) will be analyzed.

Furthermore summary statistics will be presented for demographic data and other pre-specified outcomes.

Additionally, an embedded qualitative study will be performed to explore motivation and barriers related to exercise compliance. This study will be reported in a secondary paper with a clear reference to the primary trial and trial registration.

Regional Hospital Central Jutland and The Danish Rheumatism Association is partly funding the salary for physiotherapists involved in the study. Further external funding will be applied for.

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-12
• Study Start: 2017-04-21
• Status Verified: 2019-03
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-08
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in gait speed	Change from 3 to 10 weeks after surgery.	Measured by the 40m fast-paced walk test (continous, m/sec)

Secondary Outcome Measures

Name	Time	Method
Change in hip abductor muscle strength	Change from 3 to 10 weeks after surgery	Test of isometric muscle strength in hip abduction in the operated leg. The hand-held dynamometer Power Track II Commander will be used to assess this using standardized test procedures (continous, Nm/kg)
Change in hip flexor muscle strength	Change from 3 to 10 weeks after surgery	Test of isometric muscle strength in hip flexion in the operated leg. The hand-held dynamometer Power Track II Commander will be used to assess this using standardized test procedures (continous, Nm/kg)
24-hour physical activity (mean upright time).	4 weeks after surgery	An ActivPAL movement-sensor will be used to measure mean time per day in upright position (standing and walking) based on 7 days of data collection. The sensor will be applied 3 weeks after surgery and used the following week (continous, min/day)
Gait speed	10 weeks after surgery	Measured by the 40m fast-paced walk test (continous, m/sec)
Change in patient-reported function	Change from 3 to 10 weeks after surgery.	Measured by the ADL (Activities of Daily Living) subscale of Hip disability and Osteoarthritis Outcome Score (HOOS). HOOS is a disease-specific patient-reported outcome measure (continous)
Change in patient-reported symptoms	Change from 3 to 10 weeks after surgery.	Measured by the symptoms subscale of HOOS (continous)
Change in patient-reported pain	Change from 3 to 10 weeks after surgery.	Measured by the pain subscale of HOOS (continous)
Change in lower-extremity function	Change from 3 to 10 weeks after surgery	Measured by the Chair stand test (The maximal number of rises from a chair within 30 seconds) (continous)
Change in patient-reported hip related quality of life	Change from 3 to 10 weeks after surgery.	Measured by the quality of life subscale (QoL) of HOOS (continous)
24-hour physical activity (mean number of steps)	4 weeks after surgery	An ActivPAL movement-sensor will be used to measure mean number of steps per day based on 7 days of data collection. The sensor will be applied 3 weeks after surgery and used the following week (continous, min/day)
Self-efficacy	3 weeks after surgery	The general self-efficacy scale will be used to measure self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments (continous)

Trial Locations

Locations (1)

Silkeborg Regional Hospital; 🇩🇰 Silkeborg, Denmark