NCT03584451

Brief Summary

160 patients who received a total hip arthroplasty (THA) were included and randomized to receive specific rehabilitation sport (RS) or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.4 years

First QC Date

June 4, 2018

Last Update Submit

August 16, 2018

Conditions

Total Hip ArthroplastyOsteoarthritis, HipSports Physical Therapy

Outcome Measures

Primary Outcomes (1)

  • hip-related muscular strength

    hip-related muscular strength measured with isokinetic dynamometry

    change from baseline (6 weeks) at 6 months after THA

Secondary Outcomes (11)

  • Hip pain - WOMAC

    change from 6 months to 12 months after THA

  • Physical function hip - WOMAC

    change from 6 months to 12 months after THA

  • Physical function hip - HHS

    change from 6 months to 12 months after THA

  • Physical Activity

    change from 6 months to 12 months after THA

  • health related Quality of life

    change from 6 months to 12 months after THA

  • +6 more secondary outcomes

Study Arms (2)

with rehabilitation sport

ACTIVE COMPARATOR

rehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively

Behavioral: rehabilitation sport

without rehabilitation sport

NO INTERVENTION

no further rehabilitation program after THA

Interventions

rehabilitation sportBEHAVIORAL

rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively

with rehabilitation sport

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-complicated THA
  • written informed consent

You may not qualify if:

  • complicated THA
  • partial weight-bearing after surgery
  • cardial comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

July 12, 2018

Study Start

February 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

August 17, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

no plan to share IPD