Effects of Internet / Web-based Exercises on the Population With Knee Arthritis

NCT03545048 | Completed DMC

• 1 other identifier: 18021
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To test whether internet-based exercises reduce the pain in knee OA
2. 2.To check whether internet-based exercises improve the physical activity in the patients with knee OA.
3. 3.To explore the correlation between sleep, knee inflammation (effusion, synovial hypertrophy or/and synovial hyper vascularity) and biomarkers of insulin resistance and knee pain.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Sleep Disturbance

Keywords

web-based exercises; Digital health; knee exercises

Outcome Measures

Primary Outcomes (1)

• Knee pain measured on Visual Analogue Scale

  knee pain scored on 00- 10 (00 no pain and 10 being worst pain)

  6 weeks

Secondary Outcomes (10)

• Pittsburgh sleep quality index (Sleep disturbances )

  6 weeks

• Quantitative Sensory Testing (Pressure pain threshold - PPT)

  6 weeks

• Ultrasound of the knee

  6 weeks

• Muscle mass on musculoskeletal ultrasound

  6 weeks

• The Timed Up and Go test (TUG)

  6 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

Interventional groups will have an assessment session with the experienced staff and NRS, QST, WOMAC, MSK-HQ, 30CST, TUG, PSQI, MSK-USS, urine and blood samples will be taken at baseline. Those who consent for aspiration of synovial fluid will go through the USGA procedure. Interventional group will shortly after that receive a link via email, which will be used to log-in to Joint Academy online portal. After log-in has been achieved, the intervention starts. It consist of a 6-week internet-based physical therapy program. Interventional group will be given actigraphy device (a device to monitor sleeping pattern) which is CE marked. Therefore, their sleeping pattern can be recorded quantitatively. Once exercises programme is finished in six weeks, the participants will fill in the same questionnaire and perform the physical tests, to enable evaluation.

Other: Internet based exercises

Control arm

NO INTERVENTION

Control group will continue with their routine self-management which is offered in the community setup. They will be assessed on NRS, QST, WOMAC, MSK-HQ, PSQI, 30CST, TUG, isometric muscles strengthen of quadriceps, MSK-USS, muscle mass of vastus lateralis, urine and blood samples at baseline. Control group will also get the actigraphy to monitor sleeping pattern of that group. They will be re-assessed after six weeks on the primary objective measures to see if they have made any difference by following self-management strategies in the community.

Interventions

Internet based exercises OTHER

Exercises for knee OA (online- digital health)

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Aged 45 years and onward.
• Clinical diagnosis of knee arthritis with complaints of knee pain for 3-6 months, early morning stiffness \<30 minutes, crepitus, bony tenderness, and no palpable warmth and radiographically established osteoarthritis (at least score 1 on K/L scale)
• Able to read and write English
• Able to use/access computer or tablet and have access to internet

You may not qualify if:

• Inability to give informed consent - (capacity levels are already established under General practitioner care)
• Terminal or mental illness
• Neurological conditions, inflammatory joint diseases including rheumatoid arthritis, gout or calcium pyrophosphate deposition disease (CPPD), and dementia
• Patients with sleep apnea
• Acute soft tissue injury to the knee within last 3 months before recruiting
• Unstable heart condition or rapid fluctuations in hypertension

Sponsors & Collaborators

• University of Nottingham: lead
• Arthritis Research UK: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, East Midland, NG5 1PB, United Kingdom

Location

Related Publications (2)

• Gohir SA, Eek F, Kelly A, Abhishek A, Valdes AM. Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis: The iBEAT-OA Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210012. doi: 10.1001/jamanetworkopen.2021.0012.

  PMID: 33620447 DERIVED

• Gohir SA, Greenhaff P, Abhishek A, Valdes AM. Evaluating the efficacy of Internet-Based Exercise programme Aimed at Treating knee Osteoarthritis (iBEAT-OA) in the community: a study protocol for a randomised controlled trial. BMJ Open. 2019 Oct 28;9(10):e030564. doi: 10.1136/bmjopen-2019-030564.

  PMID: 31662373 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Parasomnias

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Extended Scope Practitioner, MSK sonographer

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 4, 2018
• Study Start: October 15, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

GB (1)