Exercise in Patients With Osteoarthritis of the Hip

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387867
• Other study ID #: HOA-ISMC
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: February 5, 2015
• Start date: October 2009
• Est. completion date: January 2014

Study information

• Verified date: July 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Strength training
Supervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months
• Nordic Walking
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
Unsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine - Copenhagen & Musculoskeletal Rehabilitation Research Unit, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in illness perception from baseline to 12 months	Brief Illness Perception Questionnaire	Baseline and 12 months	No
Other	Change in arthritis-specific self-efficacy from baseline to 4 and 12 months	Arthritis-specific Self-efficacy Scale	Baseline, 4 and 12 months	No
Other	Change in perceived competence from baseline to 4 and 12 months	Perceived Competence Scale	Baseline, 4 and 12 months	No
Primary	Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months		Baseline, 2, 4 and 12 months	No
Secondary	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		Baseline, 2, 4, and 12 months	No
Secondary	Change from Baseline to 2, 4 and 12 months in lower limb extensor muscle power (Watt/kg BW) at 2, 4 and 12 months		Baseline, 2, 4, and 12 months	No
Secondary	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		Baseline, 2, 4, and 12 months	No
Secondary	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)	Baseline, 2, 4, and 12 months	No
Secondary	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	Baseline, 2, 4, and 12 months	No
Secondary	Change from Baseline in health related quality of life at 2, 4 and 12 months	SF-36	Baseline, 2, 4, and 12 months	No
Secondary	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.	Baseline and 4 months	No
Secondary	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)	Baseline and 4 months	No
Secondary	Change in task specific self-efficacy from baseline to 2, 4 and 12 months	Self-efficacy in relation to stair climbing performance.	Baseline, 2, 4 and 12 months	No
Secondary	Change in patient global assessment from baseline to 2, 4 and 12 months.		Baseline to 2, 4 and 12 months	No