Exercise-Based Strategies for Chronic Back Pain

NCT07475481 | Not Yet Recruiting

• 1 other identifier: 095/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

chronic low back pain; resistance training; exercise therapy; dynamic neuromuscular stabilization; developmental positions; intra-abdominal pressure; rehabilitation; postural stabilization

Outcome Measures

Primary Outcomes (3)

• Change in Trunk Flexor and Extensor Muscle Function

  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.

  Baseline, Week 8, Week 12, and Week 16

• Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score

  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.

  Baseline to Week 16 (1x every week)

• Change in DNS-Based Functional Postural Stabilization Performance

  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.

  Baseline, Week 8, Week 12, and Week 16

Secondary Outcomes (18)

• 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

Study Arms (5)

Supervised resistance training with OHMTRACK

EXPERIMENTAL

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.

Behavioral: Gym settings

Supervised resistance training without OHMTRACK

EXPERIMENTAL

Participants complete the same supervised gym-based resistance training program as the OHMTRACK resistance training arm, but without real-time intra-abdominal pressure biofeedback.

Behavioral: Gym settings

Supervised EDP with OHMTRACK

EXPERIMENTAL

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.

Behavioral: Physio settings

Home-based EDP with OHMTRACK

EXPERIMENTAL

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.

Behavioral: Home - based settings: exercises based on developmental positions

Active control

ACTIVE COMPARATOR

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.

Behavioral: Home - based settings: Usual activity monitoring

Interventions

Gym settings BEHAVIORAL

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.

Also known as: Agonist-antagonist paired set resistance training with OHMTRACK

Supervised resistance training with OHMTRACK; Supervised resistance training without OHMTRACK

Physio settings BEHAVIORAL

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.

Supervised EDP with OHMTRACK

Home - based settings: exercises based on developmental positions BEHAVIORAL

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.

Also known as: Exercises based on developmental positions

Home-based EDP with OHMTRACK

Home - based settings: Usual activity monitoring BEHAVIORAL

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.

Also known as: Usual activity monitoring

Active control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• The Jerzy Kukuczka Academy of Physical Education in Katowice: collaborator

Study Sites (1)

Faculty of Physical Education and Sport, Chrales University

Prague, 162 52, Czechia

Location

Central Study Contacts

Roman Jurik, Ph.D.

CONTACT

+420 775 218 277; roman.jurik@ftvs.cuni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor. Outcome assessors and statistician/data analyst are intended to remain blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Five parallel groups: supervised resistance training with OHMTRACK, supervised resistance training without OHMTRACK, supervised EDP with OHMTRACK, home-based EDP with OHMTRACK, and active control.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CZ (1)