ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 69 for:    Recruiting, Not yet recruiting, Available Studies | "Arthroplasty, Replacement, Hip"
Previous Study | Return to List | Next Study

Home-based Rehabilitation Following a Total Hip Replacement (PHETHAS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03109821
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Arthroplasty, Replacement, Hip Other: Home-based exercise

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 Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
THA patients Other: Home-based exercise

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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with end-stage hip osteoarthritis, who are scheduled for primary THA at the Elective Surgery Centre at the public hospital, Silkeborg Regional Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109821


Contacts
Contact: Lone R Mikkelsen, PhD +45 78417613 lonemike@rm.dk
Contact: Merete N Madsen, MSc +45 78416006 meremads@rm.dk

Locations
Denmark
Silkeborg Regional Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Lone Ramer Mikkelsen, PhD    +45 78417613    lonemike@rm.dk   
Contact: Merete N Madsen, MSc    +45 78416006    meremads@rm.dk   
Sponsors and Collaborators
Central Jutland Regional Hospital
Investigators
Principal Investigator: Lone R Mikkelsen, PhD Silkeborg Regional Hospital

Responsible Party: Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT03109821     History of Changes
Other Study ID Numbers: 654894
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Jutland Regional Hospital:
Exercise Therapy
Rehabilitation