Effect of Structured Exercise in Patients With Knee Osteoarthritis

Study Overview
=================
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.

Official Title
-----------------
Effect of Nordic Walking and Inspiratory Muscle Training to Promote Cardiopulmonary Function in Patients With Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee, Physical Inactivity

Intervention / Treatment
-----------------
* Device: Nordic walking or inspiratory muscle training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly allocated into intervention group or controlled group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nordic walking group or inspiratory muscle training<br>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. | Device: Nordic walking or inspiratory muscle training<br>* Nordic walking is a form of low-impact aerobic exercise that incorporates the use of walking poles. And inspiratory muscle training is a type of exercise that provides resistance during the inhalation phase.<br>|
| No Intervention: Control group<br>In control group, participants are required to maintain their daily activities and routine management. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The six-minute walk test | Cardiopulmonary function | Baseline, up to 8 weeks | 
| 30-sec chair stand test | Cardiopulmonary function | Baseline, up to 8 weeks | 
| Grip strength | Cardiopulmonary function | Baseline, up to 8 weeks | 
| Timed up-and-go test | Cardiopulmonary function | Baseline, up to 8 weeks | 
| Quadriceps strength | Cardiopulmonary function | Baseline, up to 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, pain, function