Exercise in Patients With Osteoarthritis of the Hip

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Nina Beyer, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01387867
First received: June 29, 2011
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Hip Osteoarthritis
Procedure: Strength training
Procedure: Nordic Walking
Procedure: Unsupervised home based exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Strength Training and Nordic Walking in Patients With Osteoarthritis of the Hip

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

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 [ Time Frame: Baseline, 2, 4 and 12 months ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline, 2, 4, and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline in self-reported pain level at 2, 4 and 12 months [ Time Frame: Baseline, 2, 4, and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 2, 4, and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 2, 4, and 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 2, 4 and 12 months ] [ Designated as safety issue: No ]
    Self-efficacy in relation to stair climbing performance.

  • Change in patient global assessment from baseline to 2, 4 and 12 months. [ Time Frame: Baseline to 2, 4 and 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in illness perception from baseline to 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Brief Illness Perception Questionnaire

  • Change in arthritis-specific self-efficacy from baseline to 4 and 12 months [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
    Arthritis-specific Self-efficacy Scale

  • Change in perceived competence from baseline to 4 and 12 months [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
    Perceived Competence Scale


Enrollment: 152
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strength training Procedure: Strength training
Supervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months
Experimental: Nordic Walking Procedure: Nordic Walking
Supervised Nordic Walking in groups 2 x 1 hour weekly and un-supervised Nordic Walking 1 hour weekly for 4 months
Active Comparator: Unsupervised home based exercise Procedure: Unsupervised home based exercise
Unsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387867

Locations
Denmark
Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
Copenhagen, Denmark, NV 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Nina Beyer, Ph.D. Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Assoc. Prof. Nina Beyer, Assoc. Prof., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01387867     History of Changes
Other Study ID Numbers: HOA-ISMC
Study First Received: June 29, 2011
Last Updated: July 8, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Exercise
Hip osteoarthritis
Randomized controlled trial

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014