Clinical trial NCT01387867: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Exercise
Hip osteoarthritis
Randomized controlled trial
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 152
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months
timeFrame: Baseline, 2, 4 and 12 months
Secondary outcomes:
measure: 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
timeFrame: Baseline, 2, 4, and 12 months
measure: Change from Baseline to 2, 4 and 12 months in lower limb extensor muscle power (Watt/kg BW) at 2, 4 and 12 months
timeFrame: Baseline, 2, 4, and 12 months
measure: 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
timeFrame: Baseline, 2, 4, and 12 months
measure: Change from Baseline in self-reported pain level at 2, 4 and 12 months
timeFrame: Baseline, 2, 4, and 12 months
measure: Change from Baseline in self-reported physical activity at 2, 4 and 12 months
timeFrame: Baseline, 2, 4, and 12 months
measure: Change from Baseline in health related quality of life at 2, 4 and 12 months
timeFrame: Baseline, 2, 4, and 12 months
measure: 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)
timeFrame: Baseline and 4 months
measure: Change from Baseline to 4 months in biomarkers of disease activity, inflammation, and cartilage degradation, in a subgroup (15 participants from each group)
timeFrame: Baseline and 4 months
measure: Change in task specific self-efficacy from baseline to 2, 4 and 12 months
timeFrame: Baseline, 2, 4 and 12 months
measure: Change in patient global assessment from baseline to 2, 4 and 12 months.
timeFrame: Baseline to 2, 4 and 12 months
Other outcomes:
measure: Change in illness perception from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in arthritis-specific self-efficacy from baseline to 4 and 12 months
timeFrame: Baseline, 4 and 12 months
measure: Change in perceived competence from baseline to 4 and 12 months
timeFrame: Baseline, 4 and 12 months
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital
name: Nina Beyer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: