Effect of Structured Exercise in Patients With Knee Osteoarthritis

NCT ID: NCT06084949

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2026-08-31

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.

Conditions

Osteoarthritis, Knee; Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nordic walking or inspiratory muscle training

Intervention Type: DEVICE

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.

Control group

In control group, participants are required to maintain their daily activities and routine management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kwong Wah Hospital

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy FU, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Sciences

Locations

The Hong Kong Polytechnic University

Kowloon City, Kowloon, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Tracy Tang

Role: CONTACT

tracy-wh.tang@polyu.edu.hk

+852 3400 8541

Other Identifiers

HSEARS20230703001

Identifier Type: -

Identifier Source: org_study_id