Effect of Structured Exercise in Patients With Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee; Physical Inactivity
• Interventions: Device: Nordic walking or inspiratory muscle training

• Registration Number: NCT06084949
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-10-03
• Study Start: 2023-10-05
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nordic walking group or inspiratory muscle training	Nordic walking or inspiratory muscle training	In experimental group, investigator will coordinate with the patients with mild-to-moderate knee osteoarthritis to take the Nordic walking, while the patients with end-stage knee osteoarthritis to take inspiratory muscle training. All participants are required to maintain their daily activities and routine management.

Primary Outcome Measures

Name	Time	Method
30-sec chair stand test	Baseline, up to 8 weeks	Cardiopulmonary function
Quadriceps strength	Baseline, up to 8 weeks	Cardiopulmonary function
Grip strength	Baseline, up to 8 weeks	Cardiopulmonary function
The six-minute walk test	Baseline, up to 8 weeks	Cardiopulmonary function
Timed up-and-go test	Baseline, up to 8 weeks	Cardiopulmonary function

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volume at first second	Baseline, up to 8 weeks	Pulmonary function
Inspiratory muscle strength	Baseline, up to 8 weeks	Pulmonary function
Medical Research Council scale	Baseline, up to 8 weeks	Total scores range from 0-4, the higher scores indicating a higher level of dyspnea.
Pittsburgh Sleep Quality Index	Baseline, up to 8 weeks	Total scores range from 0-21, '0' indicating no difficulty and '21' indicating severe difficulties in all areas.
Western Ontario and McMaster Universities Osteoarthritis Index	Baseline, up to 8 weeks	Knee-related symptoms and function, total scores range from 0-96, the higher scores indicating the worse symptom and function.
Forced vital capacity	Baseline, up to 8 weeks	Pulmonary function
Quadriceps muscle oxygenation	Baseline, up to 8 weeks	Quadriceps muscle function
Multidimensional Fatigue Inventory	Baseline, up to 8 weeks	Total scores range from 20-100, , the higher scores indicating a higher level of fatigue.
Actigraph	Baseline, up to 8 weeks	Physical activity level
Maximum voluntary ventilation	Baseline, up to 8 weeks	Pulmonary function
Inspiratory muscle endurance	Baseline, up to 8 weeks	Pulmonary function
Physical Activity Scales for the Elderly	Baseline, up to 8 weeks	Total scores range from 0-793, the higher scores indicating a higher level of physical activity.
12-Item Short Form Health Survey	Baseline, up to 8 weeks	Total scores range from 0-100, the higher scores indicating better physical and mental health functioning.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Kowloon City, Kowloon, Hong Kong