Clinical Trial: Exercise in Patients With Osteoarthritis of the Hip

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Strength Training and Nordic Walking in Patients With Osteoarthritis of the Hip

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.


Detailed Summary:
Sponsor: Bispebjerg Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome: Change in physical Function from Baseline to 2, 4 and 12 months [ Time Frame: Baseline, 2, 4 and 12 months ]

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • Change from Baseline in self-reported pain level at 2, 4 and 12 months [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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) [ Time Frame: Baseline and 4 months ]
    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 ]
    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 ]
    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 ]


Original Secondary Outcome:

  • Change in isometric muscle strength of the thigh and hip muscles from Baseline to 2, 4 and 12 months [ Time Frame: Baseline, 2, 4, and 12 months ]
  • Change in lower limb extensor muscle power from Baseline to 2, 4 and 12 months [ Time Frame: Baseline, 2, 4, and 12 months ]
  • Change in endurance from Baseline to 2, 4 and 12 months [ Time Frame: Baseline, 2, 4, and 12 months ]
    6-minute walk
  • Change in pain level from Baseline to 2, 4 and 12 months [ Time Frame: Baseline, 2, 4, and 12 months ]
    HOOS (Hip dysfunction and Osteoarthritis Outcome Score) and VAS (Visual Analogue scale)
  • Change in physical activity from Baseline to 2, 4 and 12 months [ Time Frame: Baseline, 2, 4, and 12 months ]
    PASE (Physical Activity Scale for the Elderly) and a question from Copenhagen City Heart Study
  • Change in health related quality of life from Baseline to 2, 4 and 12 months [ Time Frame: Baseline, 2, 4, and 12 months ]
    SF-36
  • Change from baseline in the anatomical cross sectional area of the quadriceps femoris muscle from Baseline to 4 months. The measurements are performed in a subgroup (15 participants from each group) [ Time Frame: Baseline and 4 months ]
    MRI (magnetic resonance imaging)- The anatomical cross sectional area is measured at mid-thigh level, i.e. 20 cm proximal to the tibia.
  • Change in biomarkers of disease activity, inflammation, and cartilage degradation from Baseline to 4 months, in a subgroup (15 participants from each group) [ Time Frame: Baseline and 4 months ]
    Blood samples: COMP (cartilage oligomeric matrix protein) and CRP (C-reactive protein)and Urine sample: CTX II (C-terminal telopeptide of collagen II)


Information By: Bispebjerg Hospital

Dates:
Date Received: June 29, 2011
Date Started: October 2009
Date Completion:
Last Updated: February 5, 2015
Last Verified: July 2013