NCT01164111

Brief Summary

Purpose: The purpose of this study is to determine the effect of pre operative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis. Background: Decreasing performance with age due to age related muscle loss is well known. Resistance training in elderly has shown significant effect in regaining both muscle force and function. It has been shown that a chronic condition with limitations in function as seen in osteoarthritis of the hip decreases both muscle performance and size. Studies of resistance training of the hip related muscle groups in the early postoperative period after total hip arthroplasty have shown significant effect on muscle force and function. Few studies have investigated preoperative intervention, all with lighter types of training such as water pool training. The effect of preoperative resistance training on subjects with primal osteoarthritis of the hip is yet to be described. Study hypothesis: Preoperative resistance training will significant improve outcomes on both primal and secondary effect parameters pre surgery and at 1 year followup.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

July 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

July 12, 2010

Last Update Submit

October 8, 2015

Conditions

Keywords

osteoarthritiship arthroplastyresistance trainingpreoperative training

Outcome Measures

Primary Outcomes (6)

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily living)

    Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

    0 weeks (entrypoint =T0)

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily)

    Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

    8 weeks (T1 pre surgery)

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)

    Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

    3 months (T3 -post surgery)

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)

    Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

    6 months (T4 - postsurgery)

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)

    Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative

    9 months (T5 -post surgery)

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)

    Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative

    12 months (endpoint - post surgery)

Secondary Outcomes (28)

  • Muscle Power

    0 weeks (pre surgery)

  • Muscle strength

    0 weeks (pre surgery)

  • Functional scores

    0 weeks (pre surgery)

  • Body composition: Dual Energy X-ray Absorptiometry scan(DEXA scan)

    0 weeks (pre surgery

  • Activity score: Metabolic equivalent score (MET- score)

    0 weeks (pre surgery)

  • +23 more secondary outcomes

Study Arms (2)

Preoperative resistance training

EXPERIMENTAL

preoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise. Frequency: 2 times/week

Other: Preoperative resistance training

Control

NO INTERVENTION

Standard preoperative track.: No training intervention. Standard preoperative information.

Interventions

preoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise (stated as 8-10 repetitions of the exercise). Frequency: 2 times/week. The patient follows a special training program consisting of exercises with knee and hip extension. Training intensity is followed in a personalized log-book for each patient. Sessions are conducted in small teams closely supervised by specially trained physiotherapists.

Preoperative resistance training

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients scheduled for total hip arthroplasty due to primary osteoarthritis with an age of 50 years or older.
  • Patients in the intervention group must participate in 80% of the training as a minimum and more than 2 skipped sessions in a row is not allowed.

You may not qualify if:

  • Rheumatoid arthritis (RA) or other types of arthritis other than primary osteoarthritis.
  • Uremia
  • Cancer
  • Systemic treatment with glucocorticoid more than 3 months the last 5 years with a daily dose \> 5 mg.
  • Fracture of the hip (ipsi or contralateral)
  • Other fracture of the lower extremities the last year
  • Other condition with reduced function (ex polio seq.)
  • Weight above 135 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ortopædkirurgisk Afdeling T Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (36)

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    PMID: 10936901BACKGROUND
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    PMID: 7493202BACKGROUND
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    PMID: 16926381BACKGROUND
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    PMID: 19293261BACKGROUND
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  • Holsgaard-Larsen A, Hermann A, Zerahn B, Mejdahl S, Overgaard S. Effects of progressive resistance training prior to total HIP arthroplasty - a secondary analysis of a randomized controlled trial. Osteoarthritis Cartilage. 2020 Aug;28(8):1038-1045. doi: 10.1016/j.joca.2020.04.010. Epub 2020 May 4.

  • Hermann A, Holsgaard-Larsen A, Zerahn B, Mejdahl S, Overgaard S. Preoperative progressive explosive-type resistance training is feasible and effective in patients with hip osteoarthritis scheduled for total hip arthroplasty--a randomized controlled trial. Osteoarthritis Cartilage. 2016 Jan;24(1):91-8. doi: 10.1016/j.joca.2015.07.030. Epub 2015 Aug 15.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Andreas EB Hermann, MD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 16, 2010

Study Start

October 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations