Effect of Structured Exercise in Patients With Knee Osteoarthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Physical Inactivity
• Intervention / Treatment: Device: Nordic walking or inspiratory muscle training

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tracy Tang; Phone Number: +852 3400 8541; Email: tracy-wh.tang@polyu.edu.hk

Study Locations

• Hong Kong
  • Kowloon
    • Kowloon City, Kowloon, Hong Kong
      • Recruiting
      • The Hong Kong Polytechnic University
      • Sub-Investigator: Shan SU, Msc
      • Sub-Investigator: Clare Yu, PhD
      • Sub-Investigator: Keith Wan, Dr.
      • Principal Investigator: Amy Fu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nordic walking group 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.	Device: Nordic walking or inspiratory muscle training; 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.
No Intervention: Control group; 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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Kwong Wah Hospital
• Investigators: Principal Investigator: Amy FU, PhD, Department of Rehabilitation Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: pain; exercise; function
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HSEARS20230703001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No