Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis
NCT ID: NCT06965946
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-15
2025-11-30
Brief Summary
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Detailed Description
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Intermittent hypoxia-hyperoxia training (IHHT), involving alternating periods of low (13-15%) and high (40%) oxygen concentrations, has shown promise in improving physical and psychological outcomes in musculoskeletal disorders. However, evidence regarding its efficacy in knee OA is scarce, especially in low- and middle-income countries.
This trial seeks to explore whether the combination of IHHT and conventional physical therapy leads to superior improvements in clinical outcomes compared to conventional therapy alone. Participants will undergo 12 treatment sessions over 4 weeks. The primary outcome measures include pain (NPRS), function (KOOS), balance (Timed Up and Go Test), gait (Functional Gait Assessment), and inflammatory markers (CRP). The feasibility, safety, and effectiveness of this novel intervention will also be evaluated.
The study design includes assessor and participant blinding and uses rigorous methods including pre- and post-intervention assessments and statistical analysis with SPSS. Findings from this study may inform future guidelines for non-pharmacological, low-cost interventions for knee OA rehabilitation in similar contexts.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intermittent Hypoxia-Hyperoxia + Conventional Therapy
Participants in this group will receive Intermittent Hypoxia-Hyperoxia Therapy (IHHT) administered using a hypoxia generator. Each session will include 4 cycles of 5 minutes of hypoxia (13-15% O₂) followed by 2 minutes of hyperoxia (40% O₂). This therapy will be provided before each conventional physical therapy session. A total of 12 sessions (3 per week for 4 weeks) will be administered. Conventional therapy will follow the current best practices used by physical therapists in tertiary care hospitals in Peshawar.
Intermittent Hypoxia-Hyperoxia Therapy (IHHT)
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.
Conventional Physical Therapy
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.
Conventional Therapy with Normoxic Air
Participants in this group will receive only conventional physical therapy along with normoxic air (19.8% O₂) exposure using the same device setup to maintain blinding. They will receive 4 sessions of normoxia (5 minutes) followed by 2 minutes of normoxia as a placebo for IHHT. This will also be done prior to each of the 12 physical therapy sessions (3 per week for 4 weeks).
Conventional Physical Therapy
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.
Normoxic Air Placebo
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.
Interventions
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Intermittent Hypoxia-Hyperoxia Therapy (IHHT)
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.
Conventional Physical Therapy
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.
Normoxic Air Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
45 Years
ALL
No
Sponsors
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Rehman Medical Institute - RMI
OTHER
Khyber Medical University Peshawar
OTHER
Responsible Party
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Principal Investigators
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Dr Rida Shabbir, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
Dr Haider Darain, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
Dr Aatik Arsh, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar
Locations
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Rehman Medical Institute
Peshawar, Khyber Pakhtunkhwa, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Mohd Yunus MH, Lee Y, Nordin A, Chua KH, Bt Hj Idrus R. Remodeling Osteoarthritic Articular Cartilage under Hypoxic Conditions. Int J Mol Sci. 2022 May 11;23(10):5356. doi: 10.3390/ijms23105356.
Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.
Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
Rahimi F, Sadeghisani M, Karimzadeh A. Efficacy of transcranial direct current stimulation in patients with knee osteoarthritis: A systematic review. Neurophysiol Clin. 2023 Dec;53(6):102918. doi: 10.1016/j.neucli.2023.102918. Epub 2023 Nov 8.
Benderdour M, Martel-Pelletier J, Pelletier JP, Kapoor M, Zunzunegui MV, Fahmi H. Cellular Aging, Senescence and Autophagy Processes in Osteoarthritis. Curr Aging Sci. 2015;8(2):147-57. doi: 10.2174/1874609808666150727111530.
Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.
Azizi S, Rezasoltani Z, Najafi S, Mohebi B, Tabatabaee SM, Dadarkhah A. Transcranial direct current stimulation for knee osteoarthritis: a single-blind randomized sham-controlled trial. Neurophysiol Clin. 2021 Aug;51(4):329-338. doi: 10.1016/j.neucli.2020.12.002. Epub 2020 Dec 13.
Other Identifiers
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KMU/DIR/CTU/2025/002
Identifier Type: -
Identifier Source: org_study_id
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