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Completed

NCT Number: NCT03109821

Home-based Rehabilitation Following a Total Hip Replacement

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 18 years
  • Scheduled for a primary THA, at Elective Surgery Centre, due to osteoarthritis
  • Able to understand written and spoken Danish

Exclusion criteria

  • Referral to supervised rehabilitation in the municipality

Treatment and study plan

Home-based exercise

Other

The intervention reflects the standard rehabilitation practice at Elective Surgery Centre. 3 weeks after surgery the patients will receive a thorough instruction and supervision in the strength training exercises that they are to perform without supervision at their own homes the following 7 weeks. The instruction is conducted one-to-one by physiotherapists and supported by an instruction booklet with written and illustrated exercise descriptions. The exercises included are: hip abduction, flexion and extension with elastic band resistance and sit-to-stand and one-legged stance. The prescribed training load will be two sets with repetitions to failure and a relative load of 10 to 20 RM (Repetition Maximum), performed every second day (3-4 times a week).

Exposure: Performed exercise dose will be quantified as the total physiological exercise stimulus (Time under tension summary dose) recorded by a sensor (BandCizer) attached to the elastic exercise band.

Primary outcomes

  1. Change in gait speed

    Time frame: Change from 3 to 10 weeks after surgery.

    Measured by the 40m fast-paced walk test (continous, m/sec)

Secondary outcomes

  1. Gait speed

    Time frame: 10 weeks after surgery

    Measured by the 40m fast-paced walk test (continous, m/sec)

  2. Change in patient-reported function

    Time frame: 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)

  3. Change in patient-reported symptoms

    Time frame: Change from 3 to 10 weeks after surgery.

    Measured by the symptoms subscale of HOOS (continous)

  4. Change in patient-reported pain

    Time frame: Change from 3 to 10 weeks after surgery.

    Measured by the pain subscale of HOOS (continous)

  5. Change in patient-reported hip related quality of life

    Time frame: Change from 3 to 10 weeks after surgery.

    Measured by the quality of life subscale (QoL) of HOOS (continous)

  6. Change in lower-extremity function

    Time frame: 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)

  7. Change in hip abductor muscle strength

    Time frame: 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)

  8. Change in hip flexor muscle strength

    Time frame: 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)

  9. Self-efficacy

    Time frame: 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)

  10. 24-hour physical activity (mean upright time).

    Time frame: 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)

  11. 24-hour physical activity (mean number of steps)

    Time frame: 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)

Other outcomes

  1. Number of participants with adverse events

    Time frame: 3 weeks after surgery

    Number and type of adverse events will be registered by the physiotherapist (categorical)

  2. Number of participants with adverse events

    Time frame: 10 weeks after surgery

    Number and type of adverse events will be registered by the physiotherapist (categorical)

  3. Mean change in pain after each exercise session

    Time frame: 10 weeks after surgery.

    The Visual Analogue Scale (VAS) will be used to assess pain before and after each exercise session. Data will be summarized as a mean change in pain per exercise session for the entire intervention period (continous)

  4. Motivation to perform the prescribed exercises

    Time frame: 3 weeks after surgery

    The participants will be asked about their motivation to perform the prescribed exercises. A short questionnaire developed for this purpose will be used. The possible responses are ordered in 4 levels of motivation on a ordinal scale (categorical)

Sponsors and collaborators

Lead sponsor

Central Jutland Regional Hospital

Other

Registry information

Official study title

Home-based Rehabilitation Following a Total Hip Replacement - do Patients Follow the Exercise Prescription and How Does it Relate to Postoperative Recovery? The Pragmatic Home-Based Exercise After Total Hip Arthroplasty Silkeborg 1 (PHETHAS-1) Trial

Acronym: PHETHAS-1

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2017
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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