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Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis

NCT06965946 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Osteo Arthritis Knee

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Rehman Medical Institute - RMI

    collaborator OTHER

  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Dr Rida Shabbir, PhD · Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar

  • Dr Haider Darain, PhD · Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar

  • Dr Aatik Arsh, PhD · Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2025-10-31
Completion
2025-11-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965946 on ClinicalTrials.gov