Effectiveness of Combining Intermittent Hypoxia-Hyperoxia and Conventional Physical Therapy for Patients With Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Reduction
研究概览
简要总结
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.
详细描述
Osteoarthritis (OA) is a prevalent chronic condition that leads to joint pain, stiffness, and impaired mobility, particularly among middle-aged and elderly populations. In Pakistan, knee OA is common and significantly impacts quality of life. Existing treatments are largely symptomatic and often insufficient, especially in resource-constrained settings.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study is double blind. Both participants and outcome assessors are blinded to group allocation. Randomization is conducted via OpenEpi, and intervention/control sessions are administered with controlled oxygen levels, but the appearance and procedures are standardized to maintain blinding.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conventional Physical Therapy (Procedure)
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.
干预措施: Intermittent Hypoxia-Hyperoxia Therapy (IHHT) (Procedure)
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).
干预措施: Conventional Physical Therapy (Procedure)
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).
干预措施: Normoxic Air Placebo (Procedure)
结局指标
主要结局
Pain Reduction
时间窗: Baseline and 4 weeks (12 sessions of therapy)
Measured on the Numeric Pain Rating Scale (NPRS), which has levels ranging from 0 to 10 in severity. 0 indicates no pain, and 10 indicates severe pain. The scale is divided into 3 categories. 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Functional Status - KOOS Activities of Daily Living Subscale
时间窗: Baseline and 4 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess pain, recreation and quality of life, symptoms and stiffness, ADL and functional sports. The scores of each category will be calculated and converted to percentages (100%). 0-39% will indicate severe condition, 40- 59% will indicate moderate condition, 60-79% will indicate mild condition, and 80-100% will indicate no dysfunction.
Inflammatory Marker - C-Reactive Protein (CRP)
时间窗: Baseline and 4 weeks
Change in serum CRP levels measured through a blood sample as a biomarker of osteoarthritis-related inflammation. CRP levels will be taken on a continuous scale.
Balance - Timed Up and Go Test (TUG)
时间窗: Baseline and 4 weeks
Time taken (in seconds) to rise from a chair, walk 3 meters, turn, walk back, and sit down using a stop watch. A time of \< or equal to 10 seconds will be considered normal, 11-20 seconds indicates good mobility with functional indipendence. \> or equal to 20 seconds indicates that person needs assistance outside, 30 seconds or more indicates that person is prone to fall. MCID for time up and Go test is 2.1 seconds.
次要结局
- Gait Performance - Functional Gait Assessment (FGA) Score(Baseline and 4 weeks)
- Functional mobility - 6-Minute Walk Test (6MWT)(Baseline and 4 weeks)