NCT01214954

Brief Summary

The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

September 17, 2010

Last Update Submit

November 21, 2013

Conditions

Osteoarthritis, Hip

Keywords

Total Hip ReplacementRehabilitationResistance training

Outcome Measures

Primary Outcomes (1)

  • Leg extension power

    The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)

    10 weeks postoperative

Secondary Outcomes (19)

  • Walking speed

    4 weeks postoperative

  • Sit-to-stand

    10 weeks postoperative

  • Stair test

    10 weeks postoperative

  • Hip Osteoarthritis Outcome Score (HOOS)

    6 months postoperative

  • Walking speed

    10 weeks

  • +14 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard rehabilitation

Other: Control group

Resistance training

EXPERIMENTAL

10 weeks of supervised progressive resistance training initiated within the first week after total hip replacement.

Other: Supervised progressive resistance training

Interventions

Supervised progressive resistance trainingOTHER

Resistance training 2 times/week initiated within the first week after total hip replacement. The training is supervised by physiotherapists and individually progressed.

Resistance training
Control groupOTHER

Standard rehabilitation consisting of home-based exercises with 2 postoperative instructions by a physiotherapist.

Control group

Eligibility Criteria

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

You may qualify if:

  • Total hip replacement for osteoarthrosis
  • Living within 30 km from the hospital
  • Motivated to attend training 2 times/week in 10 weeks
  • Reduced functional ability measured as: HOOS score \< 67
  • written informed consent

You may not qualify if:

  • Comorbidities such as cancer, neuromuscular diseases, heart diseases etc.
  • Cognitive impairment
  • Body mass index \> 35
  • Resurfacing prosthesis
  • Scheduled additional prosthetic surgery in lower extremity within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (2)

  • Mikkelsen LR, Petersen AK, Mechlenburg I, Mikkelsen S, Soballe K, Bandholm T. Description of load progression and pain response during progressive resistance training early after total hip arthroplasty: secondary analyses from a randomized controlled trial. Clin Rehabil. 2017 Jan;31(1):11-22. doi: 10.1177/0269215516628305. Epub 2016 Jul 10.

    PMID: 26851251DERIVED

  • Mikkelsen LR, Mechlenburg I, Soballe K, Jorgensen LB, Mikkelsen S, Bandholm T, Petersen AK. Effect of early supervised progressive resistance training compared to unsupervised home-based exercise after fast-track total hip replacement applied to patients with preoperative functional limitations. A single-blinded randomised controlled trial. Osteoarthritis Cartilage. 2014 Dec;22(12):2051-8. doi: 10.1016/j.joca.2014.09.025. Epub 2014 Oct 22.

    PMID: 25305374DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Lone R Mikkelsen, MSc.

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2010

First Posted

October 5, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2013

Study Completion

November 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

DK(1)