Effect of Structured Exercise in Patients With Knee Osteoarthritis

NCT06084949 | Recruiting DMC

• 1 other identifier: HSEARS20230703001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Physical Inactivity

Keywords

exercise; pain; function

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• Forced vital capacity

  Baseline, up to 8 weeks

• Forced expiratory volume at first second

  Baseline, up to 8 weeks

• Maximum voluntary ventilation

  Baseline, up to 8 weeks

• Inspiratory muscle strength

  Baseline, up to 8 weeks

• Inspiratory muscle endurance

  Baseline, up to 8 weeks

Study Arms (2)

Nordic walking group or inspiratory muscle training

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Nordic walking or inspiratory muscle training 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.

Nordic walking group or inspiratory muscle training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Kwong Wah Hospital: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon City, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Sedentary Behavior; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy FU, PhD

  Department of Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy Tang

CONTACT

+852 3400 8541; tracy-wh.tang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor won't know the allocation of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly allocated into intervention group or controlled group.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 16, 2023
• Study Start: October 5, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 16, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)