Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis

NCT01682980 | Active Not Recruiting DMC

• 1 other identifier: 2012/334
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Pain

Keywords

Osteoarthritis; Pain; Exercise; Function; Cartilage quality

Outcome Measures

Primary Outcomes (1)

• Knee-related quality of life

  Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale). 0 is very poor knee-related quality of life, while 100 indicates normal knee-related quality of life.

  1 year

Secondary Outcomes (3)

• Knee function

  4 months and 1 year

• Health-related quality of life

  4 months and 1 year

• Radiographic osteoarthritis progression

  2 years

Other Outcomes (4)

• Isokinetic muscle strength

  4 months and 1 year

• Maximal oxygen consumption (VO2max)

  4 months and 1 year

• Self-efficacy for pain

  4 months and 1 year

Study Arms (3)

Strength training

EXPERIMENTAL

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

Aerobic exercise

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will do as usual.

Interventions

Strength training OTHER

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.

Strength training

Aerobic exercise OTHER

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.

Aerobic exercise

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator
• Oslo Metropolitan University: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0407, Norway

Location

Related Publications (3)

• Killingmo RM, Oiestad BE, Risberg MA, Maas E, Grotle M. Cost-effectiveness of strength exercise or aerobic exercise compared with usual care for patients with knee osteoarthritis: secondary results from a multiarm randomised controlled trial in Norway. BMJ Open. 2024 May 23;14(5):e079704. doi: 10.1136/bmjopen-2023-079704.

  PMID: 38803266 DERIVED

• Oiestad BE, Aroen A, Rotterud JH, Osteras N, Jarstad E, Grotle M, Risberg MA. The efficacy of strength or aerobic exercise on quality of life and knee function in patients with knee osteoarthritis. A multi-arm randomized controlled trial with 1-year follow-up. BMC Musculoskelet Disord. 2023 Sep 8;24(1):714. doi: 10.1186/s12891-023-06831-x.

  PMID: 37684597 DERIVED

• 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.

  PMID: 24028201 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Pain; Motor Activity

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• May Arna Risberg, PhD

  Oslo University Hospital

  STUDY CHAIR

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: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: March 1, 2013
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)