Exercise in Patients With Osteoarthritis of the Hip

NCT01387867 | Completed

• 1 other identifier: HOA-ISMC
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Keywords

Exercise; Hip osteoarthritis; Randomized controlled trial

Outcome Measures

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

  Baseline, 2, 4 and 12 months

Secondary Outcomes (10)

• 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

• 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

• 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

• Change from Baseline in self-reported pain level at 2, 4 and 12 months

  Baseline, 2, 4, and 12 months

• Change from Baseline in self-reported physical activity at 2, 4 and 12 months

  Baseline, 2, 4, and 12 months

Other Outcomes (3)

• Change in illness perception from baseline to 12 months

  Baseline and 12 months

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

  Baseline, 4 and 12 months

• Change in perceived competence from baseline to 4 and 12 months

  Baseline, 4 and 12 months

Study Arms (3)

Strength training

EXPERIMENTAL

Strength training three times weekly, i.e.supervised strength training twice weekly and un-supervised strength training once weekly for 4 months.

Procedure: Strength training

Nordic Walking

EXPERIMENTAL

Nordic walking three times weekly, i.e.Nordic walking twice weekly and un-supervised Nordic walking once weekly for 4 months.

Procedure: Nordic Walking

Unsupervised home based exercise

ACTIVE COMPARATOR

The home based unsupervised exercise comprised exercises recommended by the Danish Arthritis Association.

Procedure: Unsupervised home based exercise

Interventions

Strength training PROCEDURE

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

Strength training

Nordic Walking PROCEDURE

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

Nordic Walking

Unsupervised home based exercise PROCEDURE

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

Unsupervised home based exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

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

Copenhagen, NV 2400, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Motor Activity

Interventions

Resistance Training; Nordic Walking

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Walking; Locomotion

Study Officials

• Nina Beyer, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 6, 2011
• Study Start: October 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 6, 2015

Record last verified: 2013-07

Locations

DK (1)