Exercise-Based Strategies for Chronic Back Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorCharles University, Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: Supervised resistance training with OHMTRACKExperimental treatment 1 intervention
Group B: Supervised resistance training without OHMTRACKExperimental treatment 1 intervention
Group C: Supervised EDP with OHMTRACKExperimental treatment 1 intervention
Group D: Home-based EDP with OHMTRACKExperimental treatment 1 intervention
Group E: Active controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 8, Week 12, and Week 16
2

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.

Time frame
Baseline to Week 16 (1x every week)
3

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.

Time frame
Baseline, Week 8, Week 12, and Week 16

Secondary outcomes

1

Maximal Oxygen Uptake (VO2max) During Treadmill Graded Exercise Test

Maximal oxygen uptake (VO₂max) will be assessed using a graded exercise test (GXT) on a motorized treadmill with breath-by-breath gas exchange analysis (Metalyzer metabolic cart). VO₂max will be defined as the highest 30-second averaged oxygen uptake achieved during the test and reported in mL/kg/min (and, if applicable, also in L/min). Higher VO₂max values indicate greater aerobic capacity.

Time frame
Baseline, Week 8, Week 12, and Week 16
2

Quantitative Sensory Testing - Pressure Pain Threshold

Pressure pain threshold will be assessed using quantitative sensory testing with a handheld digital pressure algometer applied at standardized anatomical sites. The outcome will be reported as the pressure at pain threshold in kilopascals (kPa). Higher PPT values indicate lower mechanical pain sensitivity.

Time frame
Baseline, Week 8, Week 12, and Week 16
3

Isometric Mid-Thigh Pull

Lower-body maximal isometric force production will be assessed using an isometric mid-thigh pull (IMTP) performed on dual force plates (ForceDecks system). The primary outcome will be peak vertical ground reaction force, reported in Newtons (N) (and, if applicable, also normalized to body mass as N/kg). Higher values indicate greater maximal isometric lower-body force.

Time frame
Baseline, Week 8, Week 12, and Week 16
4

Handgrip Strength

Handgrip (kg) is measured by Takei (TKK 5401, Japan).It will be measured for both hands (left and right). Three trials will be performed on each hand and the mean will be calculated. The standard for men over 40 years of age is 47 (±9.5) kg for the right hand and 45 (±9.3) kg for the left hand. The standard for women over 40 is 29 (±5.7) kg for the right hand and 28 (±5.7) kg for the left hand. Higher values are considered to be better.

Time frame
Baseline, Week 8, Week 12, and Week 16

Other outcomes

Sponsors and contacts

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Charles University, Czech Republic

Lead sponsor

The Jerzy Kukuczka Academy of Physical Education in Katowice

Collaborator

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