Clinical trial NCT01682980: Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis
Official title: Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Pain
Keywords: Osteoarthritis
Pain
Exercise
Function
Cartilage quality
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Oslo Metropolitan University
First posted: 2012-09-11
Enrollment: 207
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, and physical function in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable number of people worldwide. This randomized controlled trial will involve one intervention group delivered strength exercises and one 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.

Detailed description: The trial aimed to recruit 207 study participants randomly allocated to three arms. The participants had to have symptomatic knee osteoarthritis verified by grade 2-3 using the Kellgren and Lawrence radiographic classification system, and they had to have knee pain most of the days the last month and fulfil 2/3 of the ACR clinical criteria. Participants with other serious comorbidities or self-reported BMI \>35 were included.

The interventions consisted of structured strength training program over 12-14 weeks, and a structured stationary cycling program for 12-14 weeks.

Primary outcome was the KOOS knee-related quality of life subscale at the 1 year follow-up. Secondary outcomes were other patient reported outcomes, muscle strength, and peak oxygen consumption at the 4-month and 1 year follow-up, and over time (1-year).

Eligibility criteria: Inclusion Criteria:

* Women and men aged 35-70 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

Primary outcomes:
measure: Knee-related quality of life
timeFrame: 1 year
Secondary outcomes:
measure: Knee function
timeFrame: 4 months and 1 year
measure: Health-related quality of life
timeFrame: 4 months and 1 year
measure: Radiographic osteoarthritis progression
timeFrame: 2 years
Other outcomes:
measure: Isokinetic muscle strength
timeFrame: 4 months and 1 year
measure: Maximal oxygen consumption (VO2max)
timeFrame: 4 months and 1 year
measure: Self-efficacy for pain
timeFrame: 4 months and 1 year
measure: Total knee replacement
timeFrame: 5 years
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: May Arna Risberg, PhD
role: STUDY_CHAIR
References:
citation: Oiestad BE, Osteras N, Frobell R, Grotle M, Brogger H, Risberg MA. Efficacy of strength and aerobic exercise on patient-reported outcomes and structural changes in patients with knee osteoarthritis: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2013 Sep 12;14:266. doi: 10.1186/1471-2474-14-266.