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Effectiveness of Combining Intermittent Hypoxia-Hyperoxia and Conventional Physical Therapy for Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Pakistan
Rehman Medical Institute
RECRUITING
Peshawar
Contact Information
Primary
Dr Rida Shabbir, PhD*
ridashabbir@kmu.edu.pk
+923460113227
Backup
Dr Haider Darain, PhD
haiderdarain@yahoo.com
+923419990915
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Active_comparator: 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).
Sponsors
Leads: Khyber Medical University Peshawar
Collaborators: Rehman Medical Institute - RMI

This content was sourced from clinicaltrials.gov