Effect of Structured Exercise in Patients With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084949
• Other study ID #: HSEARS20230703001
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: Tracy Tang
• Phone: +852 3400 8541
• Email: tracy-wh.tang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Physical Inactivity

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Kowloon City	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Kwong Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The six-minute walk test	Cardiopulmonary function	Baseline, up to 8 weeks
Primary	30-sec chair stand test	Cardiopulmonary function	Baseline, up to 8 weeks
Primary	Grip strength	Cardiopulmonary function	Baseline, up to 8 weeks
Primary	Timed up-and-go test	Cardiopulmonary function	Baseline, up to 8 weeks
Primary	Quadriceps strength	Cardiopulmonary function	Baseline, up to 8 weeks
Secondary	Forced vital capacity	Pulmonary function	Baseline, up to 8 weeks
Secondary	Forced expiratory volume at first second	Pulmonary function	Baseline, up to 8 weeks
Secondary	Maximum voluntary ventilation	Pulmonary function	Baseline, up to 8 weeks
Secondary	Inspiratory muscle strength	Pulmonary function	Baseline, up to 8 weeks
Secondary	Inspiratory muscle endurance	Pulmonary function	Baseline, up to 8 weeks
Secondary	Quadriceps muscle oxygenation	Quadriceps muscle function	Baseline, up to 8 weeks
Secondary	Multidimensional Fatigue Inventory	Total scores range from 20-100, , the higher scores indicating a higher level of fatigue.	Baseline, up to 8 weeks
Secondary	Medical Research Council scale	Total scores range from 0-4, the higher scores indicating a higher level of dyspnea.	Baseline, up to 8 weeks
Secondary	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
Secondary	Actigraph	Physical activity level	Baseline, up to 8 weeks
Secondary	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
Secondary	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
Secondary	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