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Completed

NCT Number: NCT01387867

Exercise in Patients With Osteoarthritis of the Hip

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, NV 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strength training

Procedure

Supervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months

Nordic Walking

Procedure

Supervised Nordic Walking in groups 2 x 1 hour weekly and un-supervised Nordic Walking 1 hour weekly for 4 months

Unsupervised home based exercise

Procedure

Unsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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.

  8. 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)

  9. 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.

  10. Change in patient global assessment from baseline to 2, 4 and 12 months.

    Time frame: Baseline to 2, 4 and 12 months

Other outcomes

  1. Change in illness perception from baseline to 12 months

    Time frame: Baseline and 12 months

    Brief Illness Perception Questionnaire

  2. Change in arthritis-specific self-efficacy from baseline to 4 and 12 months

    Time frame: Baseline, 4 and 12 months

    Arthritis-specific Self-efficacy Scale

  3. Change in perceived competence from baseline to 4 and 12 months

    Time frame: Baseline, 4 and 12 months

    Perceived Competence Scale

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 6, 2011
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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