Clinical trial NCT06084949: Effect of Structured Exercise in Patients With Knee Osteoarthritis
Official title: Effect of Nordic Walking and Inspiratory Muscle Training to Promote Cardiopulmonary Function in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Physical Inactivity
Keywords: exercise
pain
function
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
First posted: 2023-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly allocated into intervention group or controlled group.
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to evaluate the effect of Nordic walking and inspiratory muscle training (IMT) on cardiopulmonary function in patients with knee osteoarthritis (OA). Mild-to-moderate knee OA patients are randomly allocated into Experimental group (Nordic walking plus routine management) or Control group (Routine management). While End-stage knee OA patients are randomly allocated into Experimental group (IMT plus pre-operative rehabilitation exercise) or Control group (Pre-operative rehabilitation exercise). Participants are invited to undergo two assessments, including baseline assessment, post-intervention assessment. Researchers will compare two groups to see if the cardiopulmonary function can be improved after intervention.

Detailed description: This study recruits patients with different stages and assigns them into different interventions and comparing the effect with those not receiving intervention. It will provide the evidence in terms of the exercise that can promote cardiopulmonary function and at the same time reduce pain and disability for patients with different stages of knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* pain on the most days in one or both knees in the past month;
* difficulty with at least one of daily living activities measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale;
* radiographic evidence of knee OA in the tibial-femoral compartment (Kellgren and Lawrence grade, K/L ≥1, K/L 1-3 regarded as mild-to-moderate knee OA, others waiting for knee arthroplasty regarded as end-stage knee OA);
* with normal or corrected visual and auditory function and walking unaided;
* primary knee OA for more than 6 months, be stable on medication for at least 3 weeks.

Exclusion Criteria:

* knee surgery priorly;
* have steroid injection in previous three weeks;
* have inflammatory arthritis (e.g., rheumatoid); or unstable angina, or myocardial infarction, or cardiac surgery; or stroke; or treatment with steroids, hormones, or cancer chemotherapy; or pulmonary diseases (force vital capacity\<80% of predicted and/or forced expiratory volume at first second\<70% of predicted); or a history of exercise-induced asthma;
* unable to understand the procedure and potential risks of the study;
* medically unstable that indicate unsafe to participate in exercise test

Primary outcomes:
measure: The six-minute walk test
timeFrame: Baseline, up to 8 weeks
measure: 30-sec chair stand test
timeFrame: Baseline, up to 8 weeks
measure: Grip strength
timeFrame: Baseline, up to 8 weeks
measure: Timed up-and-go test
timeFrame: Baseline, up to 8 weeks
measure: Quadriceps strength
timeFrame: Baseline, up to 8 weeks
Secondary outcomes:
measure: Forced vital capacity
timeFrame: Baseline, up to 8 weeks
measure: Forced expiratory volume at first second
timeFrame: Baseline, up to 8 weeks
measure: Maximum voluntary ventilation
timeFrame: Baseline, up to 8 weeks
measure: Inspiratory muscle strength
timeFrame: Baseline, up to 8 weeks
measure: Inspiratory muscle endurance
timeFrame: Baseline, up to 8 weeks
measure: Quadriceps muscle oxygenation
timeFrame: Baseline, up to 8 weeks
measure: Multidimensional Fatigue Inventory
timeFrame: Baseline, up to 8 weeks
measure: Medical Research Council scale
timeFrame: Baseline, up to 8 weeks
measure: Physical Activity Scales for the Elderly
timeFrame: Baseline, up to 8 weeks
measure: Actigraph
timeFrame: Baseline, up to 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, up to 8 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Baseline, up to 8 weeks
measure: 12-Item Short Form Health Survey
timeFrame: Baseline, up to 8 weeks
Other outcomes:
Locations:
city: Kowloon City
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: Department of Rehabilitation Sciences
name: Amy FU, PhD
role: PRINCIPAL_INVESTIGATOR
References: