Exercise-Based Strategies for Chronic Back Pain (BACK-FIT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low-back Pain (cLBP)
• Intervention / Treatment: Behavioral: Gym settings; Behavioral: Physio settings; Behavioral: Home - based settings: exercises based on developmental positions; Behavioral: Home - based settings: Usual activity monitoring

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roman Jurik, Ph.D.; Phone Number: +420 775 218 277; Email: roman.jurik@ftvs.cuni.cz

Study Locations

• Czechia
  • Prague, Czechia, 162 52
    • Faculty of Physical Education and Sport, Chrales University
    • Contact: Roman Jurik, Ph.D.; Phone Number: +420 775 218 277; Email: roman.jurik@ftvs.cuni.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Agonist-antagonist paired set resistance training with OHMTRACK
Experimental: 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.	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.; Other Names: Agonist-antagonist paired set resistance training with OHMTRACK
Experimental: 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.	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.
Experimental: 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.	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.; Other Names: Exercises based on developmental positions
Active Comparator: 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.	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.; Other Names: Usual activity monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 8, Week 12, and Week 16
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.	Baseline, Week 8, Week 12, and Week 16
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.	Baseline, Week 8, Week 12, and Week 16
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.	Baseline, Week 8, Week 12, and Week 16
Behavioral Regulation in Exercise Questionnaire (BREQ-3) Subscale Scores	Exercise motivation and self-regulation will be assessed using the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). Items are rated on a 0-4 scale (0 = not true for me, 4 = very true for me). Outcomes will be reported as subscale mean scores (range 0-4 points). Higher scores indicate greater endorsement of the respective motivation/self-regulation construct.	Baseline and Week 8
Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse events will be monitored and recorded throughout the intervention period. Events of interest include falls, injuries, musculoskeletal complaints, hypoglycemic episodes, major cardiovascular events, and any other events potentially related to study participation. Adverse events will be captured via participant self-report at each weekly contact/session and active investigator monitoring. Each event will be documented by type, onset date, duration, severity (mild/moderate/severe), seriousness (serious vs non-serious), and relatedness to the study intervention (not related/possibly/probably/definitely related). Outcomes will be reported as the number of participants experiencing ≥1 adverse event and the total number of adverse events during the intervention.	Throughout the intervention period, Weeks 1-8 (every week)
Body Mass Index (BMI)	Body mass index (BMI) will be calculated as body weight in kilograms (kg) divided by height in meters squared (m²) and reported in kg/m². Higher BMI indicates higher body mass relative to height. The World Health Organization (WHO) adult reference range for normal BMI is 18.5-24.9 kg/m².	Baseline, Week 8, Week 12, and Week 16
Total Body Fat Mass	Total body fat mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and/or InBody370S and reported in kilograms (kg).	Baseline, Week 8, Week 12, and Week 16
Lean mass	Total body lean mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and/or InBody370S and reported in kilograms (kg).	Baseline, Week 8, Week 12, and Week 16
Body Weight	Body weight will be measured using a InBody370S and reported in kilograms (kg).	Baseline, Week 8, Week 12, and Week 16
Serum Total Cholesterol Concentration	Serum total cholesterol will be measured from venous blood samples using standard clinical laboratory enzymatic assays. Results will be reported in mmol/L. Laboratory-specific reference ranges will be used for clinical interpretation (e.g., 2.90-5.00 mmol/L).	Baseline, Week 8, Week 12, and Week 16
Serum Low-Density Lipoprotein (LDL) Cholesterol Concentration	Serum LDL cholesterol will be measured from venous blood samples using standard clinical laboratory assays. Results will be reported in mmol/L. Laboratory-specific reference ranges will be used for clinical interpretation (e.g., 1.20-3.00 mmol/L).	Baseline, Week 8, Week 12, and Week 16
Serum High-Density Lipoprotein (HDL) Cholesterol Concentration	Serum HDL cholesterol will be measured from venous blood samples using standard clinical laboratory assays. Results will be reported in mmol/L. Laboratory-specific reference ranges will be used for clinical interpretation (e.g., 1.00-2.10 mmol/L).	Baseline, Week 8, Week 12, and Week 16
Fasting Blood Glucose Concentration	Fasting blood glucose will be measured from venous blood samples using standard clinical laboratory assays (e.g., enzymatic methods). Results will be reported in mmol/L. Laboratory-specific reference ranges will be used for clinical interpretation (e.g., 3.30-5.59 mmol/L).	Baseline, Week 8, Week 12, and Week 16
Systolic Blood Pressure (SBP)	Systolic blood pressure (SBP) will be assessed in a seated resting position using a validated oscillometric device with brachial cuff-based measurement (Arteriograph). Results will be reported in millimeters of mercury (mmHg). Higher values indicate higher systolic arterial pressure. For clinical interpretation, commonly used resting thresholds include <120 mmHg (normal) and ≥140 mmHg (hypertension) (thresholds may vary by guideline and population).	Baseline, Week 8, Week 12, and Week 16
Diastolic Blood Pressure (DBP)	Diastolic blood pressure (DBP) will be assessed in a seated resting position using a validated oscillometric device with brachial cuff-based measurement (Arteriograph). Results will be reported in mmHg. Higher values indicate higher diastolic arterial pressure. For clinical interpretation, commonly used resting thresholds include <80 mmHg (normal) and ≥90 mmHg (hypertension) (thresholds may vary by guideline and population).	Baseline, Week 8, Week 12, and Week 16
Aortic Pulse Wave Velocity (aPWV)	Aortic pulse wave velocity (aPWV) will be assessed using oscillometric pulse wave analysis with a brachial cuff-based system (Arteriograph). Results will be reported in meters per second (m/s). Higher aPWV values indicate greater arterial stiffness. For clinical interpretation, ~10 m/s is commonly used as a threshold indicating increased arterial stiffness in adults, although reference values vary by age and blood pressure.	Baseline, Week 8, Week 12, and Week 16
Resting Heart Rate (RHR)	Resting heart rate will be assessed during seated rest using a cuff-based oscillometric measurement (Arteriograph). Results will be reported in beats per minute (bpm). Higher values indicate higher resting heart rate. In adults, a commonly cited resting reference range is approximately 60-100 bpm (may vary with fitness level, medications, and clinical status).	Baseline, Week 8, Week 12, and Week 16

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; chronic low back pain; intra-abdominal pressure; exercise therapy; resistance training; dynamic neuromuscular stabilization; developmental positions; postural stabilization
• Other Study ID Numbers: 095/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No