Innovative Exercise-Based Strategies for Managing Chronic Back Pain: A Multisystem Health Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Trunk Flexor and Extensor Muscle Function
研究概览
简要总结
This randomized, controlled, five-arm, parallel-group trial will evaluate the effects of 8 weeks of supervised resistance training and developmental position-based exercise, with or without real-time non-invasive intra-abdominal pressure biofeedback, in adults aged 40 to 60 years with chronic low back pain. The trial will compare supervised gym-based agonist-antagonist paired set resistance training with OHMTRACK, supervised gym-based resistance training without OHMTRACK, supervised physiotherapy-based developmental exercise with OHMTRACK, home-based developmental exercise with OHMTRACK, and an active control condition. Primary outcomes will assess changes in pain and physical function after the intervention. Secondary outcomes will include neuromuscular coordination, postural stabilization, cardiovascular, respiratory, metabolic, behavioral, feasibility, and follow-up outcomes.
详细描述
Chronic low back pain is a prevalent and multifactorial condition associated with impaired physical function, reduced quality of life, and substantial socioeconomic burden. Exercise therapy, especially resistance training, is an important non-pharmacological treatment strategy, but the integration of exercise with real-time monitoring of intra-abdominal pressure remains underexplored. This study will examine whether combining exercise with non-invasive intra-abdominal pressure biofeedback can improve trunk stabilization, movement control, pain, and broader health outcomes.
The trial includes a 2-week familiarization phase, an 8-week intervention phase, and an 8-week post-intervention follow-up without structured exercise. Participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five parallel groups. The supervised gym-based program uses full-body agonist-antagonist paired set resistance training twice weekly for 60 minutes, with three sets of 10 repetitions at 75 percent of one-repetition maximum, 90-second rest intervals, and a 3-0-2-1 tempo. The supervised physiotherapy and home-based arms use developmental position-based exercise emphasizing trunk stabilization, breathing coordination, support, and movement quality. OHMTRACK biofeedback will be used in selected groups to support real-time regulation of intra-abdominal pressure.
Outcome measures will cover pain, trunk muscle function, postural stabilization, body composition, cardiovascular health, respiratory function, metabolic health, strength, functional capacity, adherence, behavioral regulation, and adverse events. Measurements are scheduled at baseline, during the intervention, and through follow-up to examine both immediate and retained effects.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor. Outcome assessors and statistician/data analyst are intended to remain blinded to group assignment.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic low back pain lasting more than 12 weeks, with current low back pain at screening/baseline.
- •Resting blood pressure below 139/89 mmHg.
- •Health status allowing participation in moderate-intensity resistance training and aerobic activity.
- •Physically active, but not professional athletes.
- •Non-smoker.
- •Able and willing to provide written informed consent and comply with study procedures
排除标准
- •Absolute or relative contraindications to resistance training or other clinically relevant cardiovascular contraindications.
- •Coronary artery disease, heart rhythm disorders, acute myocarditis, Marfan syndrome, or other cardiovascular conditions judged unsafe by the study physician.
- •History of myocardial infarction, cerebrovascular disease, peripheral vascular disease, or grade II-IV hypertension.
- •Type 1 or type 2 diabetes mellitus.
- •Severe obesity (BMI >= 40.0 kg/m2).
- •Infectious disease at screening (for example, COVID-19 or influenza).
- •Current treatment for chronic low back pain from another healthcare provider.
- •Prior spine surgery or lower-limb surgery.
- •Structural spinal deformity such as spondylolisthesis or spondylolysis.
- •Spinal fracture, inflammatory spinal disorder, or neurological signs of nerve root compromise, including decreased tendon reflexes, sensory loss, or motor deficits.
- •Dizziness during exercise.
- •Use of medications other than analgesics and non-steroidal anti-inflammatory drugs, unless specifically approved by the study physician.
研究组 & 干预措施
Supervised resistance training with OHMTRACK
Participants complete a 2-week supervised familiarization phase followed by 8 weeks of supervised full-body agonist-antagonist paired set resistance training twice weekly for 60 minutes in the gym setting. Training load is based on 75 percent of 1RM, with three sets of 10 repetitions, 90-second rest intervals, and a 3-0-2-1 tempo. Real-time OHMTRACK biofeedback is used to support breathing mechanics and trunk stabilization.
干预措施: Gym settings (Behavioral)
Supervised resistance training without OHMTRACK
Participants complete the same supervised gym-based resistance training program as the OHMTRACK resistance training arm, but without real-time intra-abdominal pressure biofeedback.
干预措施: Gym settings (Behavioral)
Supervised EDP with OHMTRACK
Participants complete a 2-week supervised familiarization phase followed by 8 weeks of supervised developmental position-based exercise twice weekly for 60 minutes in the physiotherapy setting. Sessions emphasize movement quality, breathing coordination, support, movement phases, deep trunk stabilization, and real-time intra-abdominal pressure regulation.
干预措施: Physio settings (Behavioral)
Home-based EDP with OHMTRACK
Participants complete a 2-week familiarization phase using electronic instructions, manuals, and video recordings, followed by 8 weeks of home-based developmental position-based exercise twice weekly for 60 minutes. Participants may contact the research team with questions. Real-time OHMTRACK biofeedback is used to support self-correction and breathing coordination.
干预措施: Home - based settings: exercises based on developmental positions (Behavioral)
Active control
Proposed wording based on the source protocol: participants continue their usual daily activities and wear a Fitbit Inspire 2 for step monitoring, without a structured resistance training or developmental exercise program. This description should be confirmed or replaced if the control condition includes additional procedures.
干预措施: Home - based settings: Usual activity monitoring (Behavioral)
结局指标
主要结局
Change in Trunk Flexor and Extensor Muscle Function
时间窗: Baseline, Week 8, Week 12, and Week 16
Trunk Flexor Muscle Strength (Isokinetic Peak Torque): Trunk flexor muscle function will be assessed using an isokinetic dynamometer (Cybex NORM or HUMAC NORM system). The primary outcome will be peak torque during trunk flexion, reported in Newton-meters (N·m) (and, if applicable, normalized to body mass as N·m/kg). Higher values indicate greater trunk flexor strength. Trunk Extensor Muscle Strength (Isokinetic Peak Torque): Trunk extensor muscle function will be assessed using an isokinetic dynamometer (Cybex NORM or HUMAC NORM system). The primary outcome will be peak torque during trunk extension, reported in N·m (and, if applicable, normalized to body mass as N·m/kg). Higher values indicate greater trunk extensor strength.
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score
时间窗: Baseline to Week 16 (1x every week)
Pain intensity and pain-related characteristics will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The outcome will be the SF-MPQ total score, calculated as the sum of 15 descriptor items rated on a 0-3 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Total score ranges from 0 to 45 points, with higher scores indicating worse pain and lower scores indicating improvement.
Change in DNS-Based Functional Postural Stabilization Performance
时间窗: Baseline, Week 8, Week 12, and Week 16
Abdominal wall tension will be measured during the performance of standardized DNS functional tests using a wearable abdominal wall tension monitoring belt (OHMBelt). The device provides continuous, noninvasive, device-derived estimates of abdominal wall tension, which are related to changes in intra-abdominal pressure. Outcomes will include peak abdominal wall tension and mean abdominal wall tension recorded during each DNS test, reported in device-derived units (arbitrary units, a.u.) (and/or as change from baseline, as applicable). Higher values indicate greater abdominal wall tension during task performance.
次要结局
- Maximal Oxygen Uptake (VO2max) During Treadmill Graded Exercise Test(Baseline, Week 8, Week 12, and Week 16)
- Quantitative Sensory Testing - Pressure Pain Threshold(Baseline, Week 8, Week 12, and Week 16)
- Isometric Mid-Thigh Pull(Baseline, Week 8, Week 12, and Week 16)
- Handgrip Strength(Baseline, Week 8, Week 12, and Week 16)
- Behavioral Regulation in Exercise Questionnaire (BREQ-3) Subscale Scores(Baseline and Week 8)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(Throughout the intervention period, Weeks 1-8 (every week))
- Body Mass Index (BMI)(Baseline, Week 8, Week 12, and Week 16)
- Total Body Fat Mass(Baseline, Week 8, Week 12, and Week 16)
- Lean mass(Baseline, Week 8, Week 12, and Week 16)
- Body Weight(Baseline, Week 8, Week 12, and Week 16)
- Serum Total Cholesterol Concentration(Baseline, Week 8, Week 12, and Week 16)
- Serum Low-Density Lipoprotein (LDL) Cholesterol Concentration(Baseline, Week 8, Week 12, and Week 16)
- Serum High-Density Lipoprotein (HDL) Cholesterol Concentration(Baseline, Week 8, Week 12, and Week 16)
- Fasting Blood Glucose Concentration(Baseline, Week 8, Week 12, and Week 16)
- Systolic Blood Pressure (SBP)(Baseline, Week 8, Week 12, and Week 16)
- Diastolic Blood Pressure (DBP)(Baseline, Week 8, Week 12, and Week 16)
- Aortic Pulse Wave Velocity (aPWV)(Baseline, Week 8, Week 12, and Week 16)
- Resting Heart Rate (RHR)(Baseline, Week 8, Week 12, and Week 16)