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| Name | Class |
|---|---|
| University of Crete (School of Medicine) | UNKNOWN |
| University General Hospital of Heraklion | OTHER |
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The goal of this clinical trial is to learn whether adding breathing training to an exercise program can improve pain, mood, and thinking skills in adults with chronic spinal pain.
The main questions it aims to answer are:
Researchers will compare three groups to see if adding breathing training provides additional benefits:
Participants will:
Participants in the combined group will also:
This study examined the effects of a structured exercise program, with or without diaphragmatic breathing training, in adults with chronic non-specific musculoskeletal pain of the spine.
Chronic pain was defined as pain persisting for at least 12 weeks or recurring over a prolonged period. Non-specific musculoskeletal pain refers to pain that cannot be attributed to a specific underlying pathology, such as fracture, trauma, or systemic disease, and is not associated with conditions that require surgical treatment.
Participants were recruited from the general population through an open call distributed across academic, clinical, and occupational settings. Individuals who expressed interest were screened for eligibility according to predefined criteria.
Eligible participants were randomly assigned to one of three groups: an exercise-only group, a combined exercise and diaphragmatic breathing group, or a minimal intervention control group. All participants in the intervention groups followed a 12-week program that included supervised and home-based sessions.
The exercise program was designed to improve spinal mobility, functional movement, flexibility, and neuromuscular control through progressive, multi-planar exercises performed in seated and standing positions. The combined intervention group additionally received training in diaphragmatic breathing supported by biofeedback during supervised sessions and practiced breathing exercises independently at home.
The control group received psychoeducation and general recommendations for physical activity, including walking, stretching, and relaxation techniques.
Validated clinical, psychological, and neuropsychological measures were used to assess pain, emotional status, quality of life, cognitive performance, and behavioral responses. These measures were administered at baseline, after completion of the intervention, and at follow-up.
All procedures were conducted according to predefined protocols to ensure consistency across groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise-only intervention | Experimental | Participants followed a structured exercise program delivered in supervised and home-based (unsupervised) sessions over a 12-week period. |
|
| Combined Exercise and Diaphragmatic Breathing intervention | Experimental | Participants followed the same structured exercise program and additionally received diaphragmatic breathing training supported by biofeedback during supervised sessions. They also practiced diaphragmatic breathing independently at home, without biofeedback support or supervision. |
|
| Minimal intervention control | No Intervention | Participants received psychoeducation and general recommendations for physical activity, including walking, stretching, and relaxation techniques, without supervised sessions or participation in a structured intervention program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Exercise program | Behavioral | A structured exercise program targeting spinal mobility, muscular strengthening, postural control, flexibility, and neuromuscular coordination. Exercises were performed in seated and standing positions and included multi-planar functional movements, stretching, and mobilization of joints and neural tissue. The program was delivered over 12 weeks with one supervised session per week and additional unsupervised home-based sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity and pain-related interference | Pain intensity and interference were assessed using the Brief Pain Inventory - Short Form (BPI-SF). Pain severity and interference scores range from 0 to 10, with higher scores indicating greater pain and functional impact. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
| Emotional status (anxiety and depression) | Emotional status was assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item instrument with two subscales (anxiety and depression), each item scored from 0 to 3, with higher scores indicating greater symptom severity. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
| Cognitive flexibility | Cognitive flexibility was assessed using the Trail Making Test (Part A and Part B) and the Stroop Color-Word Test. Performance was evaluated based on completion time and interference indices, with higher completion times and greater interference indicating lower cognitive flexibility. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the intervention | Adherence was defined as the total time (in minutes) of home-based (unsupervised) practice, recorded prospectively by participants throughout the intervention period using standardized weekly logs. Participants documented the frequency, type, and duration of exercise and, where applicable, diaphragmatic breathing practice. | Throughout the 12-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Semantic and Phonemic Verbal Fluency Performance | Verbal fluency was assessed using semantic and phonemic fluency tasks. Performance was measured as the number of correct words generated within a fixed time interval, with higher scores indicating better verbal fluency and cognitive flexibility. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anastasia Gr Beneka, PhD | Democritus University of Thrace | Principal Investigator |
| Panagiotis G. Simos, PhD | University of Crete, School of Medicine, Department of Psychiatry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Heraklion | Crete | Greece | |||
| Democritus University of Thrace, Department of Physical Education and Sport Science |
Individual participant data will not be shared due to data protection regulations and confidentiality requirements
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Participants were randomly assigned to one of three parallel groups: an exercise-only group, a combined exercise and diaphragmatic breathing group, or a minimal intervention control group. The design allows comparison of the effects of exercise alone versus exercise combined with breathing training, as well as comparison with a minimal intervention condition.
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| Diaphragmatic Breathing Training | Behavioral | A biofeedback-assisted breathing intervention involving slow, controlled diaphragmatic breathing with emphasis on nasal inhalation and prolonged exhalation. Breathing was guided by visual pacing to regulate rhythm and promote a target breathing rate. Training was delivered during supervised sessions and practiced independently at home throughout the intervention period. |
|
| Quality of life (WHOQOL-BREF total and domain scores) | Quality of life was assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF), a 26-item instrument measuring physical, psychological, social, and environmental domains. Items are rated on a 5-point Likert scale, with higher scores indicating better perceived quality of life. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
| Nonverbal Reasoning Performance (WAIS-IV Matrix Reasoning) | Nonverbal reasoning ability was assessed using the Matrix Reasoning subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV). Scores reflect abstract reasoning and problem-solving ability, with higher scores indicating better performance. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
| Illness Perceptions (Illness Perception Questionnaire) | Illness perceptions were assessed using the Illness Perception Questionnaire (IPQ), which evaluates cognitive and emotional representations of illness. Higher scores reflect stronger or more negative illness-related beliefs, depending on the subscale. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
| Coping Strategies (Brief COPE) | Coping strategies were assessed using the Brief COPE questionnaire. The instrument evaluates different coping responses to stress, with higher scores indicating greater use of specific coping strategies. | Baseline, post-intervention (12 weeks), and 4-week follow-up |
| Komotini |
| Thrace |
| Greece |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |