Exercise Therapy in Patients With Knee Osteoarthritis

NCT02024126 | Unknown DMC

• 2 other identifiers: TOM-TOR-2009KI-TOM-TOR-2013
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is one of the most common form of chronic diseases in the adult population, and approximately 800 000 people in Sweden (population of 9 million people) suffer from this disease, which causes joint pain, stiffness, swelling, loss of function and sick leave. There is increasing evidence that exercise therapy is effective for patients with knee OA. However, there is little knowledge on long-term effects and what type of exercises dosage is most effective. In this present clinical trial, which is a Nordic collaborative project with researchers from different research groups in Sweden and Norway, we intend to investigate short and long-term effects comparing high dosage exercise therapy (each treatment lasting 80 to 90 min) vs. a relatively low dosage exercise program (25 to 30 min) in patients diagnosed with knee OA. Patients in both intervention groups receive three treatments a week for 12 weeks making a total of 36 treatments. Primary outcome is pain-ratings and function (The Knee Injury and Osteoarthritis Outcome Score (KOOS)). Secondary outcome concerns various health-ratings and objective functional tests. Regarding predictors for outcome, we plan also to investigate different psychosocial variables as well as patient's beliefs regarding exercise. Feasibility of how high-dose exercise therapy actually works in primary care health care settings is also planned to be reported. Patients are being assessed by blinded assessor at inclusion, at end of intervention (3 mo), and at six and 12 mo after end of treatment. We plan to include a total of 200 subjects from primary health care settings, two in Norway and two in Sweden, with radiographic-verified knee OA with knee pain and decreased function. The patients have to be within the 45 to 85 age group. Patients are excluded if they have been scheduled for knee surgery or have some other form of illness/disease that limits the exercise tolerance (e.g. heart disease or systemic/metabolic diseases or chronic obstructive airways disease). A major goal is to grade exercises so that they are performed pain-free or close to pain-free in both intervention groups. The principle of deloading is used to meet this goal using a high number of repetitions in sets as pain modulation. The results from this study will give new information about the effectiveness of graded exercise therapy in patients with knee OA, and new knowledge if outcome can be related to the exercise dosage performed.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Exercise therapy; RCT; Intervention; Knee pain; Muticenter; Knee function

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Self-assessed function (KOOS) at three months follow-up (other follow-ups with this measure includes six and 12 months follow-up).

  The primary outcome measure is the disease specific Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS assesses the patients' self-report of pain, other symptoms, activities of daily living, sport and recreation function, and knee-related quality of life, answering 42 questions which take about 10 minutes to complete. The KOOS is scored from 0 to 100, separately for each subscale, 0 indicating extreme problems and 100 indicating no problems.

  At three months follow-up, i.e. after end of treatment (primary end point). In addition, during the intervention period, the KOOS are assessed after every sixth treatment meaning after 2, 4, 6, 8, 10 weeks, as well as at 6 and 12 months follow-up.

Secondary Outcomes (5)

• Patient Satisfaction

  After treatment at three months follow-up

• Anxiety and depression

  At baseline, at three months, at six months and at one year follow-up

• Catastrophizing

  At baseline, at three months, at six months and at one year follow-up

• Tama Scale of Kinesiophobia (TSK)

  At baseline, at three months, at six months and at one year follow-up

• Change from baseline in self assessed pain using a visal analogue scale (VAS) at three months follow-up (other follow-ups with this measure includes six and 12 months follow-up)

  At three months follow-up, i.e. after end of treatment. In addition, during the intervention period, the VAS are assessed after every sixth treatment meaning after 2, 4, 6, 8, 10 weeks, as well as at 6 and 12 months follow-up.

Other Outcomes (4)

• 20 min walk test.

  At inclusion and at three months follow-up, i.e. after end of treatment

• 30s Maximal Repeated Unilateral Knee Bending test

  At inclusion and at three months follow-up, i.e. after end of treatment

• the Five Time Repeated Chair Stands.

  At inclusion and at three months follow-up, i.e. after end of treatment

Study Arms (2)

High dosage exercise therapy

EXPERIMENTAL

The high-dosage exercise treatment will be conducted under supervision of experienced physiotherapists, and it follows an exercise protocol previously described as Medical Exercise Therapy, MET. The regimen contains different semi-global and local exercises for the knee. To be able to reach a high number of repetitions despite ongoing pain, the principle of de-loading (reducing weight) will be applied. The use of de-loading allows high number of repetitions nearly or entirely pain free. Later, as the patient improves and tolerates increased loading, the exercises are adapted to be more functional, using closed chain exercises without de-loading the body. Each of the exercises will be performed in 3 sets of 30 repetitions with 30-60s rest in between. Global exercises using a stationary bike will be performed three times during one treatment-session; first 20 minutes as global pain modulation, ten minutes in the middle of the treatment, and then ten minutes at the end of the treatment.

Other: Exercise therapy

Lower dosage exercise therapy

ACTIVE COMPARATOR

Patients in the comparison-/control group will perform six exercises, of which, five will be in 2 sets of 10 repetitions combining local and semi-global exercises, again using the principle of de-loading. The five semi-global and local exercises are the same as performed in the MET-group, and the regimen will be supervised in the same manner as for the MET-group. The therapy starts with 10 minutes using a stationary bike, and the same principles will be applied as for the MET-group regarding grading and follow-up with exercises and adjusting the exercises so that they are performed close to pain-free.

Other: Exercise therapy

Interventions

Exercise therapy OTHER

Exercise therapy

High dosage exercise therapy; Lower dosage exercise therapy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 45-85 yrs with an x-ray verified knee osteoarthritis with pain and decreased function.

You may not qualify if:

• Inflammatory joint disease, current anterior cruciate ligament injury, hip symptoms more aggravating than the knee symptoms, scheduled to have knee replacement surgery within 12 months, and co-morbidities not allowing exercise like cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Västervik hospital (Västervik, Sweden; recruiting clinical unit): collaborator
• City Rehab (Luleå, Sweden; recruiting clinical unit): collaborator
• Moholt Fysioterapi (Trondheim, Norway; recruiting clinical unit): collaborator
• Rosenborg klinikken (Trondheim, Norway; recruiting clinical unit): collaborator
• Frisk 3 (Mosjöen, Norway; recruiting clinical unit): collaborator
• NTNU (Norwegian Univ Science and Tech), Faculty of Health and Social Sciences: collaborator

Study Sites (1)

Karolinska Institutet

Huddinge, Stockholm County, SE-14183, Sweden

Location

Related Publications (3)

• Rugelbak GM, Torstensen TA, Paulsberg F, Grooten WJA, Osteras H. Does exercise adherence influence outcome in knee osteoarthritis? - a secondary analysis of a superiority randomized controlled trial. Physiother Theory Pract. 2025 Oct 31:1-15. doi: 10.1080/09593985.2025.2579576. Online ahead of print.

  PMID: 41170926 DERIVED

• Torstensen TA, Osteras H, LoMartire R, Rugelbak GM, Grooten WJA, Ang BO. High- Versus Low-Dose Exercise Therapy for Knee Osteoarthritis : A Randomized Controlled Multicenter Trial. Ann Intern Med. 2023 Feb;176(2):154-165. doi: 10.7326/M22-2348. Epub 2023 Jan 24.

  PMID: 36689746 DERIVED

• Torstensen TA, Grooten WJA, Osteras H, Heijne A, Harms-Ringdahl K, Ang BO. How does exercise dose affect patients with long-term osteoarthritis of the knee? A study protocol of a randomised controlled trial in Sweden and Norway: the SWENOR Study. BMJ Open. 2018 May 5;8(5):e018471. doi: 10.1136/bmjopen-2017-018471.

  PMID: 29730615 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Björn O Äng, Assoc.prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 31, 2013
• Study Start: December 1, 2013
• Primary Completion: August 31, 2017
• Study Completion: September 30, 2021
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)