Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis
Effectiveness of Combining Intermittent Hypoxia-Hyperoxia and Conventional Physical Therapy for Patients With Knee Osteoarthritis: A Randomized Controlled Trial
Khyber Medical University Peshawar
60 participants
May 15, 2025
INTERVENTIONAL
Conditions
Summary
This randomized controlled trial aims to evaluate the effectiveness of combining intermittent hypoxia-hyperoxia therapy (IHHT) with conventional physical therapy in improving pain, function, gait, balance, and general health among patients with knee osteoarthritis. The study will be conducted at the Physical Therapy Department of Rehman Medical Institute, Peshawar, Pakistan, over a period of one year.
Eligibility
Inclusion Criteria6
- Participants aged 45 and above.
- Participants (both male and female) with knee pain for 3 months or more with any three of the following six items: age of 50 years or more, crepitations, enlarged bone, no palpable warmth, morning stiffness for less than 30 minutes, and bony tenderness.
- Patients who can walk and have a minimum score of 4 on the Numeric Pain Rating Scale.
- Participants who have intact cognition with a score of 24 and above on Mini Mini- Mental State examination.
- Participants able to walk independently for at least 45 meters in the 6-minute walk test.
- Participants having a recent X-ray (done within the past 3 months).
Exclusion Criteria6
- Patients with hip or knee arthroplasty.
- Participants with above or below knee surgery or radiating pain to the lower limb.
- Patients with history of epilepsy, pregnancy
- Diagnosed neurological condition that affects lower-limb strength or walk (e.g., stroke/ basal ganglia dysfunction/ trauma)
- Patients who refused to participate in the study or to be randomly allocated.
- Patients receiving steroids or any medicine other than that prescribed by the screening orthopaedic surgeon.
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Interventions
Participants receive 4 cycles per session of 5 minutes of hypoxia (13-15% O₂) followed by 2 minutes of hyperoxia (40% O₂) using a hypoxia generator (Olive OLV 10H). Sessions are delivered before each conventional physical therapy session, 3 times per week for 4 weeks (total 12 sessions). Participants are monitored for heart rate, blood pressure, and oxygen saturation throughout the intervention.
Participants receive individualized conventional physical therapy for knee osteoarthritis based on current clinical practices in tertiary hospitals of Peshawar. Therapy is delivered 3 times per week for 4 weeks (total 12 sessions) and includes strength training, mobility exercises, and patient education.
Participants in the control group inhale normoxic air (19.8% O₂) using the same Olive OLV 10H hypoxia generator to maintain blinding. Each session consists of 4 cycles of 5 minutes of normoxia followed by 2 minutes of normoxia, simulating the timing of hypoxia-hyperoxia therapy. Sessions are administered prior to conventional physical therapy, 3 times per week for 4 weeks (total 12 sessions). Patients are monitored for vital signs throughout.
Locations(1)
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NCT06965946