NCT07475481

Exercise-Based Strategies for Chronic Back Pain

Innovative Exercise-Based Strategies for Managing Chronic Back Pain: A Multisystem Health Approach

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Low-back Pain (cLBP)

Interventions

Type	Name	Description
BEHAVIORAL	Gym settings	An 8-week supervised full-body resistance training program preceded by a 2-week familiarization phase (4 sessions). During the intervention phase, participants perform training twice weekly for 60 minutes per session. Each session includes a 10-minute warm-up, 40-minute main phase, and 10-minute cool-down. The program consists of 3 sets of 10 repetitions at 75% of 1RM, 90-second rest intervals, and a 3-0-2-1 movement tempo. Training is delivered in a gym setting under professional supervision. Resistance training with or without real-time OHMTRACK biofeedback monitor which support breathing mechanics and trunk stabilization.
BEHAVIORAL	Physio settings	An 8-week supervised exercise program based on developmental positions and neurophysiological principles, preceded by a 2-week familiarization phase (4 sessions). Participants exercise twice weekly for 60 minutes per session under physiotherapist supervision. Sessions focus on breathing coordination, deep trunk stabilization, postural control, support function, and movement quality using structured developmental movement sequences.
BEHAVIORAL	Home - based settings: exercises based on developmental positions	An 8-week home-based exercise program based on developmental positions and neurophysiological principles, preceded by a 2-week familiarization phase (4 sessions). Participants perform exercises twice weekly for 60 minutes per session using electronic manuals and video instructions. The program emphasizes breathing coordination, deep trunk stabilization, postural control, and self-correction of movement quality in an unsupervised home setting, with the possibility of contacting the research team for support.
BEHAVIORAL	Home - based settings: Usual activity monitoring	Participants continue their usual daily activities without participating in a structured resistance training or developmental position exercise program. Physical activity is monitored throughout the study using a wearable activity tracker to record daily step counts and overall movement behavior.

Timeline

• Start date: 2027-07-01
• Primary completion: 2028-03-31
• Completion: 2030-03-31
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Czechia