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NCT Number: NCT06084949

Effect of Structured Exercise 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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Kowloon City, Kowloon, Hong Kong

Location status: Recruiting

Location contact

Amy Fu, PhD

PRINCIPAL_INVESTIGATOR

Clare Yu, PhD

SUB_INVESTIGATOR

Keith Wan, Dr.

SUB_INVESTIGATOR

Shan SU, Msc

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The six-minute walk test

    Time frame: Baseline, up to 8 weeks

    Cardiopulmonary function

  2. 30-sec chair stand test

    Time frame: Baseline, up to 8 weeks

    Cardiopulmonary function

  3. Grip strength

    Time frame: Baseline, up to 8 weeks

    Cardiopulmonary function

  4. Timed up-and-go test

    Time frame: Baseline, up to 8 weeks

    Cardiopulmonary function

  5. Quadriceps strength

    Time frame: Baseline, up to 8 weeks

    Cardiopulmonary function

Secondary outcomes

  1. Forced vital capacity

    Time frame: Baseline, up to 8 weeks

    Pulmonary function

  2. Forced expiratory volume at first second

    Time frame: Baseline, up to 8 weeks

    Pulmonary function

  3. Maximum voluntary ventilation

    Time frame: Baseline, up to 8 weeks

    Pulmonary function

  4. Inspiratory muscle strength

    Time frame: Baseline, up to 8 weeks

    Pulmonary function

  5. Inspiratory muscle endurance

    Time frame: Baseline, up to 8 weeks

    Pulmonary function

  6. Quadriceps muscle oxygenation

    Time frame: Baseline, up to 8 weeks

    Quadriceps muscle function

  7. Multidimensional Fatigue Inventory

    Time frame: Baseline, up to 8 weeks

    Total scores range from 20-100, , the higher scores indicating a higher level of fatigue.

  8. Medical Research Council scale

    Time frame: Baseline, up to 8 weeks

    Total scores range from 0-4, the higher scores indicating a higher level of dyspnea.

  9. Physical Activity Scales for the Elderly

    Time frame: Baseline, up to 8 weeks

    Total scores range from 0-793, the higher scores indicating a higher level of physical activity.

  10. Actigraph

    Time frame: Baseline, up to 8 weeks

    Physical activity level

  11. Pittsburgh Sleep Quality Index

    Time frame: Baseline, up to 8 weeks

    Total scores range from 0-21, '0' indicating no difficulty and '21' indicating severe difficulties in all areas.

  12. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: Baseline, up to 8 weeks

    Knee-related symptoms and function, total scores range from 0-96, the higher scores indicating the worse symptom and function.

  13. 12-Item Short Form Health Survey

    Time frame: Baseline, up to 8 weeks

    Total scores range from 0-100, the higher scores indicating better physical and mental health functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Tracy Tang

CONTACT

[email protected]

+852 3400 8541

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Kwong Wah Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2023
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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