NCT03109821

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

April 21, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

March 27, 2017

Last Update Submit

March 16, 2020

Conditions

Arthroplasty, Replacement, Hip

Keywords

Exercise TherapyRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in gait speed

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

    Change from 3 to 10 weeks after surgery.

Secondary Outcomes (11)

  • Gait speed

    10 weeks after surgery

  • Change in patient-reported function

    Change from 3 to 10 weeks after surgery.

  • Change in patient-reported symptoms

    Change from 3 to 10 weeks after surgery.

  • Change in patient-reported pain

    Change from 3 to 10 weeks after surgery.

  • Change in patient-reported hip related quality of life

    Change from 3 to 10 weeks after surgery.

  • +6 more secondary outcomes

Other Outcomes (4)

  • Number of participants with adverse events

    3 weeks after surgery

  • Number of participants with adverse events

    10 weeks after surgery

  • Mean change in pain after each exercise session

    10 weeks after surgery.

  • +1 more other outcomes

Study Arms (1)

THA patients

Other: Home-based exercise

Interventions

Home-based exerciseOTHER

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.

THA patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Referral to supervised rehabilitation in the municipality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (2)

  • Madsen MN, Mikkelsen LR, Rathleff MS, Thorborg K, Kallemose T, Bandholm T. Hip strengthening exercise dosage is not associated with clinical improvements after total hip arthroplasty - a prospective cohort study (the PHETHAS-1 study). BMC Musculoskelet Disord. 2024 Nov 19;25(1):928. doi: 10.1186/s12891-024-08057-x.

    PMID: 39563311DERIVED

  • Mikkelsen LR, Madsen MN, Rathleff MS, Thorborg K, Rossen CB, Kallemose T, Bandholm T. Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1). F1000Res. 2019 Jun 25;8:965. doi: 10.12688/f1000research.19570.2. eCollection 2019.

    PMID: 31448107DERIVED

Study Officials

  • Lone R Mikkelsen, PhD

    Silkeborg Regional Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 12, 2017

Study Start

April 21, 2017

Primary Completion

January 8, 2020

Study Completion

January 8, 2020

Last Updated

March 17, 2020

Record last verified: 2019-03

Locations

DK(1)