Trial record 15 of 449 for:    Open Studies | "Osteoarthritis"

Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis

This study is currently recruiting participants.
Verified August 2013 by Oslo University Hospital
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01682980
First received: September 7, 2012
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

The overall contribution of this study is to increase the knowledge of the efficacy of strength and aerobic exercise on knee related quality of life, knee pain,physical function and the morphology of the cartilage in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable amount of people worldwide. The randomized controlled trial will involve one intervention group delivered strength exercises compared to another intervention group delivered aerobic exercise (ergometer cycling). The two intervention groups will be compared to a control group undergoing usual care. Cost-effectiveness analysis will be performed comparing the three groups. The study is funded from The Research Council of Norway.


Condition Intervention
Osteoarthritis
Pain
Other: Strength training
Other: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes and Structural Changes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Knee-related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale).


Secondary Outcome Measures:
  • Knee function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The KOOS is a self-administered knee-specific questionnaire containing 5-item Likert scales on pain, other symptoms, activities of daily living (ADL), function in sports and recreation and knee-related (QOL).

  • Health-related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Radiographic osteoarthritis progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Conventional x-rays will be used to assess radiographic progression of osteoarthritis


Other Outcome Measures:
  • Cartilage morphology measures (MRI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    MRI techniques including T2 mapping and T1rho sequences.

  • Isokinetic muscle strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Maximal oxygen consumption (VO2max) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Self-efficacy for pain (ASES) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Total knee replacement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    We will register continuously numbers of total knee replacements during the follow-up years.


Estimated Enrollment: 207
Study Start Date: March 2013
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strength training
The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks.
Other: Strength training
The strength training will be delivered 2-3 times per week for 12 weeks, 5-8 repetitions maximum in 3 series. The patients must warm up 5 minutes on an ergometer cycle. The following muscle groups will be trained: Quadriceps and hamstrings, hip muscles (abductors and extensors), calf muscles. A home exercise program will be delivered including one leg exercises and balance exercises. Progression will follow a 2+ principle. For instance, when the study participant is able to perform 2 more repetitions, more loads are required.
Experimental: Aerobic exercise
The aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 75% of maximal heart rate (calculated with formula for maximal heart rate reserve).
Other: Aerobic exercise
The aerobic exercise program include ergometer cycling for at least 45 minutes 2-3 times a week on 75-80% of max heart rate will be required.
No Intervention: Control group
The control group will do as usual.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men aged 45-65 years
  • Clinical knee OA according to the American College of Rheumatology Clinical Criteria
  • Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

  • Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
  • Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
  • Known coronary heart diseases or cancer
  • Body mass index > 35
  • Scheduled for surgery in any joint
  • Known mental or psychologic diseases
  • Known drug abuse
  • Persons who already perform sports related moderate physical activity more than two times a week
  • Contraindications for magnetic resonance imaging (specific point list at Oslo University Hospital, radiographic department)
  • Not speaking Norwegian language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682980

Contacts
Contact: Britt Elin Øiestad, PhD +4792803089 Britt.E.Oiestad@nimi.no
Contact: May Arna Risberg, PhD mayarna.risberg@nimi.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Britt Elin Øiestad, PhD    +4792803089    Britt.E.Oiestad@nimi.no   
Principal Investigator: Britt Elin Øiestad, PhD         
Sub-Investigator: May Arna Risberg, PhD         
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
Study Chair: May Arna Risberg, PhD Oslo University Hospital
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01682980     History of Changes
Other Study ID Numbers: 2012/334
Study First Received: September 7, 2012
Last Updated: August 7, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Osteoarthritis
Pain
Exercise
Function
Cartilage quality

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014