Clinical trial NCT05173064: Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain
Official title: Effects of a Machine Learning-based Lower Limb Exercise Training System for Older Adults With Knee Pain: A Proof-of-concept Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: knee pain, physical therapy, exercise
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be a 12-week randomized controlled trial that aims to examine the effects of a machine learning-based lower limb exercise training system for older adults with knee pain. Participants will be randomly allocated to either the machine learning-based lower limb exercise training system group (intervention arm), video-based exercise training system group (intervention arm), or usual care group (control arm). Data will be collected at baseline, and at 4, 8, and 12 weeks after randomization.

Detailed description: Knee pain, often caused by osteoarthritis, is a prevalent musculoskeletal disorder among older adults and significantly reduces physical function and quality of life. Exercise therapy has been shown to be an effective form of treatment for knee pain. However, the traditional delivery of exercise therapy requires that individuals attend clinics to participate in face-to-face exercise sessions, which can be expensive and inconvenient. In recent years, information technologies have been used to support the delivery of exercise programs. The programs have also shown great benefits in improving the management of knee pain. However, it remains a concern that physical therapists are not able to provide the patients with direct and immediate supervision when exercises are taken place remotely at home or in community centers, which can be detrimental to exercise performance and the management of knee pain.

Thus, the research team has developed a machine learning-based exercise training system to provide evidence-based lower limb exercise videos, real-time movement feedback, and tracking of exercise progress for older adults with knee pain. In this study, a proof-of-concept randomized controlled trial will be conducted to examine the effects of the machine learning-based exercise training system, comparing with the effects of video-based exercise training system (providing exercise videos alone but no real-time movement feedback or tracking of exercise progress) and effects of usual care.

Eligibility criteria: Inclusion Criteria:

Participants will be recruited if they

* age ≥ 55 years,
* have knee pain, stiffness, or both in one or both knees on most days for at least one month during the past 12 months, or have consulted healthcare professionals with their pain, stiffness, or both in one or both knees during the past 12 months,
* are able to perform the exercises required in physical assessments and exercise training,
* are able to speak and read Chinese,
* are able to provide written informed consent.

Exclusion Criteria:

Individuals will be excluded if they have

* inflammatory arthritis,
* acute trauma,
* malignancy,
* history of knee replacement,
* being on the waiting list for knee surgery,
* physical therapy for knee problems during the past three months,
* intra-articular injection to the knee within six months.

Primary outcomes:
measure: Changes in knee pain as assessed by the 5-item pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in physical function as assessed by the 17-item physical function subscale of WOMAC
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
Secondary outcomes:
measure: Changes in severity of knee pain over the previous 7 days as assessed by an 11-point numerical rating scale
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in physical function as assessed by 30-second chair-stand test
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in physical function as assessed by 40 m fast-paced walk test
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in physical function as assessed by timed up-and-go test
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in severity rating of patient nominated main functional problems over the previous 3 days
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in self-efficacy as assessed by the 8-item Arthritis Self-efficacy Scale
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in psychological distress as assessed by the Hospital Anxiety and Depression Scale
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in quality of life as assessed by the EQ-5D-5L
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
measure: Changes in participants' perceived global assessment of change in knee pain
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
Other outcomes:
measure: Changes in acceptance of the interventions
timeFrame: from baseline to 4 weeks, 8 weeks, and 12 weeks
Locations:
Study officials:
References:
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citation: Hurley MV, Walsh NE, Mitchell H, Nicholas J, Patel A. Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial. Arthritis Care Res (Hoboken). 2012 Feb;64(2):238-47. doi: 10.1002/acr.20642.
citation: Chen T, Or CK, Chen J. Effects of technology-supported exercise programs on the knee pain, physical function, and quality of life of individuals with knee osteoarthritis and/or chronic knee pain: A systematic review and meta-analysis of randomized controlled trials. J Am Med Inform Assoc. 2021 Feb 15;28(2):414-423. doi: 10.1093/jamia/ocaa282.
citation: Hay EM, Foster NE, Thomas E, Peat G, Phelan M, Yates HE, Blenkinsopp A, Sim J. Effectiveness of community physiotherapy and enhanced pharmacy review for knee pain in people aged over 55 presenting to primary care: pragmatic randomised trial. BMJ. 2006 Nov 11;333(7576):995. doi: 10.1136/bmj.38977.590752.0B. Epub 2006 Oct 20.