Osteoarthritis, KneeNCT06084949
Effect of Structured Exercise in Patients With Knee Osteoarthritis
A study testing Nordic walking or inspiratory muscle training in people with Osteoarthritis, Knee and Physical Inactivity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Physical Inactivity
- What is being tested?
- Nordic walking or inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Oct 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Kowloon City, Kowloon
Shan SU, Msc
Clare Yu, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Nordic walking or inspiratory muscle training
- Keywords
- exercise, pain, function
- Medical subject headings
- Osteoarthritis, Knee, Sedentary Behavior, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic walking or inspiratory muscle trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The six-minute walk test
Cardiopulmonary function
Measured: Baseline, up to 8 weeks
30-sec chair stand test
Cardiopulmonary function
Measured: Baseline, up to 8 weeks
Grip strength
Cardiopulmonary function
Measured: Baseline, up to 8 weeks
Timed up-and-go test
Cardiopulmonary function
Measured: Baseline, up to 8 weeks
Quadriceps strength
Cardiopulmonary function
Measured: Baseline, up to 8 weeks
Secondary outcomes (13)
Forced vital capacity
Pulmonary function
Measured: Baseline, up to 8 weeks
Forced expiratory volume at first second
Pulmonary function
Measured: Baseline, up to 8 weeks
Maximum voluntary ventilation
Pulmonary function
Measured: Baseline, up to 8 weeks
Inspiratory muscle strength
Pulmonary function
Measured: Baseline, up to 8 weeks
Inspiratory muscle endurance
Pulmonary function
Measured: Baseline, up to 8 weeks
Quadriceps muscle oxygenation
Quadriceps muscle function
Measured: Baseline, up to 8 weeks
Multidimensional Fatigue Inventory
Total scores range from 20-100, , the higher scores indicating a higher level of fatigue.
Measured: Baseline, up to 8 weeks
Medical Research Council scale
Total scores range from 0-4, the higher scores indicating a higher level of dyspnea.
Measured: 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.
Measured: Baseline, up to 8 weeks
Actigraph
Physical activity level
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start5 Oct 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated into intervention group or controlled group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital
- Responsible party
- Sponsor
- Investigators
- Amy FU, PhD, Principal investigator, Department of Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084949
- Sponsor's protocol ID
- HSEARS20230703001
- Status last verified
- Sep 2023
- First submitted
- 3 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nordic Walking and Inspiratory Muscle Training to Promote Cardiopulmonary Function in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06084949
- Acronym / sponsor ID
- HSEARS20230703001
- Conditions
- Osteoarthritis, Knee, Physical Inactivity
- Keywords
- exercise, pain, function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated into intervention group or controlled group.
| Arm | Type | Receives |
|---|---|---|
| Nordic walking group or inspiratory muscle training | Experimental | Device: Nordic walking or inspiratory muscle trainingIn 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. |
| Control group | No intervention | –In control group, participants are required to maintain their daily activities and routine management. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic walking or inspiratory muscle trainingNordic 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. | Device | Nordic walking group or inspiratory muscle training |
Primary outcome
The six-minute walk test
Time frame: Baseline, up to 8 weeks
Cardiopulmonary function
30-sec chair stand test
Time frame: Baseline, up to 8 weeks
Cardiopulmonary function
Grip strength
Time frame: Baseline, up to 8 weeks
Cardiopulmonary function
Timed up-and-go test
Time frame: Baseline, up to 8 weeks
Cardiopulmonary function
Quadriceps strength
Time frame: Baseline, up to 8 weeks
Cardiopulmonary function
13 secondary outcomes
Forced vital capacity
Time frame: Baseline, up to 8 weeks
Forced expiratory volume at first second
Time frame: Baseline, up to 8 weeks
Maximum voluntary ventilation
Time frame: Baseline, up to 8 weeks
Inspiratory muscle strength
Time frame: Baseline, up to 8 weeks
Inspiratory muscle endurance
Time frame: Baseline, up to 8 weeks
Quadriceps muscle oxygenation
Time frame: Baseline, up to 8 weeks
Multidimensional Fatigue Inventory
Time frame: Baseline, up to 8 weeks
Medical Research Council scale
Time frame: Baseline, up to 8 weeks
Physical Activity Scales for the Elderly
Time frame: Baseline, up to 8 weeks
Actigraph
Time frame: Baseline, up to 8 weeks
Pittsburgh Sleep Quality Index
Time frame: Baseline, up to 8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline, up to 8 weeks
12-Item Short Form Health Survey
Time frame: Baseline, up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy FU, PhD principal investigator
Department of Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic walking or inspiratory muscle training in people with Osteoarthritis, Knee and Physical Inactivity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracy Tang (+852 3400 8541, tracy-wh.tang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The six-minute walk test (time frame: Baseline, up to 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.