Back to resultsEffect of Structured Exercise in Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee, Physical Inactivity
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Nordic walking or inspiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring exercise, pain, function
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
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nordic walking group or inspiratory muscle training
Control group
Arm Description
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.
In control group, participants are required to maintain their daily activities and routine management.
Outcomes
Primary Outcome Measures
The six-minute walk test
Cardiopulmonary function
30-sec chair stand test
Cardiopulmonary function
Grip strength
Cardiopulmonary function
Timed up-and-go test
Cardiopulmonary function
Quadriceps strength
Cardiopulmonary function
Secondary Outcome Measures
Forced vital capacity
Pulmonary function
Forced expiratory volume at first second
Pulmonary function
Maximum voluntary ventilation
Pulmonary function
Inspiratory muscle strength
Pulmonary function
Inspiratory muscle endurance
Pulmonary function
Quadriceps muscle oxygenation
Quadriceps muscle function
Multidimensional Fatigue Inventory
Total scores range from 20-100, , the higher scores indicating a higher level of fatigue.
Medical Research Council scale
Total scores range from 0-4, the higher scores indicating a higher level of dyspnea.
Physical Activity Scales for the Elderly
Total scores range from 0-793, the higher scores indicating a higher level of physical activity.
Actigraph
Physical activity level
Pittsburgh Sleep Quality Index
Total scores range from 0-21, '0' indicating no difficulty and '21' indicating severe difficulties in all areas.
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.
12-Item Short Form Health Survey
Total scores range from 0-100, the higher scores indicating better physical and mental health functioning.
Full Information
NCT ID
NCT06084949
First Posted
October 3, 2023
Last Updated
October 12, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
Kwong Wah Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06084949
Brief Title
Effect of Structured Exercise in Patients With Knee Osteoarthritis
Official Title
Effect of Nordic Walking and Inspiratory Muscle Training to Promote Cardiopulmonary Function in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2023 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Kwong Wah Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Physical Inactivity
Keywords
exercise, pain, function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly allocated into intervention group or controlled group.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and outcomes assessor won't know the allocation of participants.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nordic walking group or inspiratory muscle training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In control group, participants are required to maintain their daily activities and routine management.
Intervention Type
Device
Intervention Name(s)
Nordic walking or inspiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
The six-minute walk test
Description
Cardiopulmonary function
Time Frame
Baseline, up to 8 weeks
Title
30-sec chair stand test
Description
Cardiopulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Grip strength
Description
Cardiopulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Timed up-and-go test
Description
Cardiopulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Quadriceps strength
Description
Cardiopulmonary function
Time Frame
Baseline, up to 8 weeks
Secondary Outcome Measure Information:
Title
Forced vital capacity
Description
Pulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Forced expiratory volume at first second
Description
Pulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Maximum voluntary ventilation
Description
Pulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Inspiratory muscle strength
Description
Pulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Inspiratory muscle endurance
Description
Pulmonary function
Time Frame
Baseline, up to 8 weeks
Title
Quadriceps muscle oxygenation
Description
Quadriceps muscle function
Time Frame
Baseline, up to 8 weeks
Title
Multidimensional Fatigue Inventory
Description
Total scores range from 20-100, , the higher scores indicating a higher level of fatigue.
Time Frame
Baseline, up to 8 weeks
Title
Medical Research Council scale
Description
Total scores range from 0-4, the higher scores indicating a higher level of dyspnea.
Time Frame
Baseline, up to 8 weeks
Title
Physical Activity Scales for the Elderly
Description
Total scores range from 0-793, the higher scores indicating a higher level of physical activity.
Time Frame
Baseline, up to 8 weeks
Title
Actigraph
Description
Physical activity level
Time Frame
Baseline, up to 8 weeks
Title
Pittsburgh Sleep Quality Index
Description
Total scores range from 0-21, '0' indicating no difficulty and '21' indicating severe difficulties in all areas.
Time Frame
Baseline, up to 8 weeks
Title
Western Ontario and McMaster Universities Osteoarthritis Index
Description
Knee-related symptoms and function, total scores range from 0-96, the higher scores indicating the worse symptom and function.
Time Frame
Baseline, up to 8 weeks
Title
12-Item Short Form Health Survey
Description
Total scores range from 0-100, the higher scores indicating better physical and mental health functioning.
Time Frame
Baseline, up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Tang
Phone
+852 3400 8541
Email
tracy-wh.tang@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy FU, PhD
Organizational Affiliation
Department of Rehabilitation Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Kowloon City
State/Province
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan SU, Msc
First Name & Middle Initial & Last Name & Degree
Clare Yu, PhD
First Name & Middle Initial & Last Name & Degree
Keith Wan, Dr.
First Name & Middle Initial & Last Name & Degree
Amy Fu, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Learn more about this trial
Effect of Structured Exercise in Patients With Knee Osteoarthritis
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