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Exercise in Patients With Osteoarthritis of the Hip

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Strength training
Nordic Walking
Unsupervised home based exercise
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Exercise, Hip osteoarthritis, Randomized controlled trial

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1)Home-dwelling 60+ year old persons with primary, symptomatic hip OA who meet the clinical criteria of hip OA according to American College of Rheumatology (ACR), and who are not on a waiting list for hip joint replacement.

Exclusion Criteria:

  1. symptomatic OA in the knee or the big toe,
  2. joint replacement of the knee or the hip,
  3. other types of arthritis, e.g., rheumatoid arthritis,
  4. previous hip fracture,
  5. limitation in physical function to the extent that using public transportation is impossible,
  6. co-morbidity that prevents exercising,
  7. physiotherapy related to hip problems within the last 3 months,
  8. steroid injections in the hip joint within the last 3 months,
  9. performing exercise/sports 2+ times weekly, and
  10. inability to cooperate.

Sites / Locations

  • Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Strength training

Nordic Walking

Unsupervised home based exercise

Arm Description

Strength training three times weekly, i.e.supervised strength training twice weekly and un-supervised strength training once weekly for 4 months.

Nordic walking three times weekly, i.e.Nordic walking twice weekly and un-supervised Nordic walking once weekly for 4 months.

The home based unsupervised exercise comprised exercises recommended by the Danish Arthritis Association.

Outcomes

Primary Outcome Measures

Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months

Secondary Outcome Measures

Change from Baseline to 2, 4 and 12 months in isometric muscle strength (N) of the thigh and hip muscles at 2, 4 and 12 months
Change from Baseline to 2, 4 and 12 months in lower limb extensor muscle power (Watt/kg BW) at 2, 4 and 12 months
Change from Baseline to 2, 4 and 12 months in 6 minute walking distance (m), stair climbing time (s), 15 s marching on the spot (number of knee lifts), Timed-Up-and-Go (s) at 2, 4 and 12 months
Change from Baseline in self-reported pain level at 2, 4 and 12 months
HOOS (Hip dysfunction and Osteoarthritis Outcome Score) and VAS (Visual Analogue scale)
Change from Baseline in self-reported physical activity at 2, 4 and 12 months
PASE (Physical Activity Scale for the Elderly) and a question from Copenhagen City Heart Study
Change from Baseline in health related quality of life at 2, 4 and 12 months
SF-36
Change from Baseline to 4 months in the anatomical cross sectional area (cm2) of the quadriceps femoris muscle measured with MRI. The measurements are performed in a subgroup (15 participants from each group)
MRI (magnetic resonance imaging)- The anatomical cross sectional area is measured at mid-thigh level, i.e. 20 cm proximal to the tibia plateau.
Change from Baseline to 4 months in biomarkers of disease activity, inflammation, and cartilage degradation, in a subgroup (15 participants from each group)
Blood samples: COMP (cartilage oligomeric matrix protein) and CRP (C-reactive protein)and Urine sample: CTX II (C-terminal telopeptide of collagen II)
Change in task specific self-efficacy from baseline to 2, 4 and 12 months
Self-efficacy in relation to stair climbing performance.
Change in patient global assessment from baseline to 2, 4 and 12 months.

Full Information

First Posted
June 29, 2011
Last Updated
February 5, 2015
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01387867
Brief Title
Exercise in Patients With Osteoarthritis of the Hip
Official Title
Effects of Strength Training and Nordic Walking in Patients With Osteoarthritis of the Hip
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
According to Danish and international guidelines the recommended first-line of management for people with osteoarthritis consist of exercise, education, analgesic medication, and, if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in patients with knee OA, but the effect of exercise on hip OA is sparsely investigated. Aim of the study: To investigate the effects of 1) strength training, and 2) Nordic Walking, and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical activity, and health related quality of life in patients with osteoarthritis of the hip. The effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e., disease activity, inflammation, and cartilage degradation, are investigated in a subgroup (n=45) of the participants. Study hypotheses: Strength training will have a greater effect on physical function and muscle strength than Nordic Walking and home based exercise; 2) Nordic Walking will have a greater effect on endurance than strength training and unsupervised home based exercise; 3) Strength training and Nordic Walking will have a greater effect on pain level and health related quality of life than unsupervised home based exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Exercise, Hip osteoarthritis, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Experimental
Arm Description
Strength training three times weekly, i.e.supervised strength training twice weekly and un-supervised strength training once weekly for 4 months.
Arm Title
Nordic Walking
Arm Type
Experimental
Arm Description
Nordic walking three times weekly, i.e.Nordic walking twice weekly and un-supervised Nordic walking once weekly for 4 months.
Arm Title
Unsupervised home based exercise
Arm Type
Active Comparator
Arm Description
The home based unsupervised exercise comprised exercises recommended by the Danish Arthritis Association.
Intervention Type
Procedure
Intervention Name(s)
Strength training
Intervention Description
Supervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months
Intervention Type
Procedure
Intervention Name(s)
Nordic Walking
Intervention Description
Supervised Nordic Walking in groups 2 x 1 hour weekly and un-supervised Nordic Walking 1 hour weekly for 4 months
Intervention Type
Procedure
Intervention Name(s)
Unsupervised home based exercise
Intervention Description
Unsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months
Primary Outcome Measure Information:
Title
Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months
Time Frame
Baseline, 2, 4 and 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline to 2, 4 and 12 months in isometric muscle strength (N) of the thigh and hip muscles at 2, 4 and 12 months
Time Frame
Baseline, 2, 4, and 12 months
Title
Change from Baseline to 2, 4 and 12 months in lower limb extensor muscle power (Watt/kg BW) at 2, 4 and 12 months
Time Frame
Baseline, 2, 4, and 12 months
Title
Change from Baseline to 2, 4 and 12 months in 6 minute walking distance (m), stair climbing time (s), 15 s marching on the spot (number of knee lifts), Timed-Up-and-Go (s) at 2, 4 and 12 months
Time Frame
Baseline, 2, 4, and 12 months
Title
Change from Baseline in self-reported pain level at 2, 4 and 12 months
Description
HOOS (Hip dysfunction and Osteoarthritis Outcome Score) and VAS (Visual Analogue scale)
Time Frame
Baseline, 2, 4, and 12 months
Title
Change from Baseline in self-reported physical activity at 2, 4 and 12 months
Description
PASE (Physical Activity Scale for the Elderly) and a question from Copenhagen City Heart Study
Time Frame
Baseline, 2, 4, and 12 months
Title
Change from Baseline in health related quality of life at 2, 4 and 12 months
Description
SF-36
Time Frame
Baseline, 2, 4, and 12 months
Title
Change from Baseline to 4 months in the anatomical cross sectional area (cm2) of the quadriceps femoris muscle measured with MRI. The measurements are performed in a subgroup (15 participants from each group)
Description
MRI (magnetic resonance imaging)- The anatomical cross sectional area is measured at mid-thigh level, i.e. 20 cm proximal to the tibia plateau.
Time Frame
Baseline and 4 months
Title
Change from Baseline to 4 months in biomarkers of disease activity, inflammation, and cartilage degradation, in a subgroup (15 participants from each group)
Description
Blood samples: COMP (cartilage oligomeric matrix protein) and CRP (C-reactive protein)and Urine sample: CTX II (C-terminal telopeptide of collagen II)
Time Frame
Baseline and 4 months
Title
Change in task specific self-efficacy from baseline to 2, 4 and 12 months
Description
Self-efficacy in relation to stair climbing performance.
Time Frame
Baseline, 2, 4 and 12 months
Title
Change in patient global assessment from baseline to 2, 4 and 12 months.
Time Frame
Baseline to 2, 4 and 12 months
Other Pre-specified Outcome Measures:
Title
Change in illness perception from baseline to 12 months
Description
Brief Illness Perception Questionnaire
Time Frame
Baseline and 12 months
Title
Change in arthritis-specific self-efficacy from baseline to 4 and 12 months
Description
Arthritis-specific Self-efficacy Scale
Time Frame
Baseline, 4 and 12 months
Title
Change in perceived competence from baseline to 4 and 12 months
Description
Perceived Competence Scale
Time Frame
Baseline, 4 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1)Home-dwelling 60+ year old persons with primary, symptomatic hip OA who meet the clinical criteria of hip OA according to American College of Rheumatology (ACR), and who are not on a waiting list for hip joint replacement. Exclusion Criteria: symptomatic OA in the knee or the big toe, joint replacement of the knee or the hip, other types of arthritis, e.g., rheumatoid arthritis, previous hip fracture, limitation in physical function to the extent that using public transportation is impossible, co-morbidity that prevents exercising, physiotherapy related to hip problems within the last 3 months, steroid injections in the hip joint within the last 3 months, performing exercise/sports 2+ times weekly, and inability to cooperate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Beyer, Ph.D.
Organizational Affiliation
Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
NV 2400
Country
Denmark

12. IPD Sharing Statement

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Exercise in Patients With Osteoarthritis of the Hip

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