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| Name | Class |
|---|---|
| Hospital General Universitario Gregorio Marañon | OTHER |
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The aim of this study was to evaluate the feasibility, safety, and acceptability of a supervised, combined moderate-intensity aerobic and resistance training program designed to reduce pain sensitization in BCS with persistent pain. Secondary objectives included assessing changes in pain intensity, somatosensory sensitivity, and temporal summation, while tertiary objectives focused on improvements in quality of life and functional capacity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-Intensity Exercise | Experimental | The experimental group followed a structured five-week program combining moderate-intensity aerobic and resistance training, totaling 150 minutes per week, and supervised by physiotherapists. Exercise intensity was monitored using the Borg and OMNI-Res perceived exertion scales, with prior familiarization sessions provided. Adherence was supported through attendance tracking, reminder messages, and motivational feedback. Unlike previous studies focused on fatigue or quality of life, this protocol targeted pain modulation based on neurophysiological mechanisms. Sessions included step-based aerobic routines and resistance exercises with bands, with clear safety and effort guidelines in place. No drugs or devices were used during the intervention. |
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| Control Group | No Intervention | Participants maintained usual activities for five weeks without changing exercise habits. No additional interventions (drugs, devices, or procedures) were applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | The experimental group completed a five-week supervised program combining moderate-intensity aerobic and resistance training (150 min/week). Intensity was monitored using the Borg and OMNI-Res scales after familiarization sessions. Adherence was encouraged through reminders, motivational messages, and follow-ups. Unlike prior studies, this intervention focused specifically on neurophysiological pain modulation. Sessions included step-based aerobic exercises and resistance training with elastic bands under safety protocols. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence by Tolerance: number of incomplete sessions | This variable captures tolerance-related indicators, including number of incomplete sessions. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Tolerance: number of sessions at moderate intensity | This variable captures tolerance-related indicators, including number of sessions at moderate intensity. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Tolerance: number of participants completing at moderate intensity | This variable captures tolerance-related indicators, including number of participants completing at moderate intensity. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Tolerance: number of progressions during the program | This variable captures tolerance-related indicators, including number of progressions during the program. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Tolerance: final progression level reached | This variable captures tolerance-related indicators, including final progression level reached. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) | The BPI consists of 11 items: four assessing intensity and seven evaluating interference in areas such as general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life. Scores range from 0 to 10, with higher scores indicating greater pain or interference. The BPI has demonstrated strong test-retest reliability (0.59-0.94), internal consistency in cancer populations (Cronbach's alpha 0.81-0.89), and construct validity across various demographic and clinical subgroups |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos | Recruiting | Madrid | Spain |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000377 | Agnosia |
| D010146 | Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Motivation: number of absences | This variable aggregates motivation-related indicators, including number of absences.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Motivation: percentage of sessions recovered after absence | This variable aggregates motivation-related indicators, including percentage of sessions recovered after absence. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Motivation: number of dropouts | This variable aggregates motivation-related indicators, including number of dropouts.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Motivation: number of presence of positive sensations | This variable aggregates motivation-related indicators, including number of presence of positive sensations (e.g., satisfaction, motivation).This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Adherence by Motivation: number of occurrence of adverse effects | This variable aggregates motivation-related indicators, including number of occurrence of adverse effects.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Numerical Rating Scale (NRS) | Pain intensity was measured using the Numerical Rating Scale (NRS), which ranges from 0 ("no pain") to 10 ("worst imaginable pain"). This scale has shown high reproducibility in assessing pain exacerbations (Cohen's κ = 0.86) and overall pain intensity (Cohen's κ = 0.80) | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) | A validated Spanish-language tool composed of seven yes/no items, with scores ranging from 0 to 24. A score of 12 or higher indicates a high probability of neuropathic pain, while a score below 12 suggests a low likelihood. The S-LANSS has demonstrated strong diagnostic properties, with 85% sensitivity and 80% specificity | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| SENSORIMOTOR CHARACTERISTICS: HANDGRIP STRENGTH | Handgrip strength was assessed using a Jamar hydraulic dynamometer set to the second handle position. Participants performed three 5-second maximal isometric contractions per hand, with 30-second rests between attempts. The average of the three trials was used for analysis, starting with the non-operated side. Standardized verbal instructions and countdowns were given to ensure consistency. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Somatosensorial status (QST): MECHANICAL DETECTION THRESHOLD (MDT) | Calibrated Von Frey monofilaments were applied perpendicularly to the skin until the filament just bent. Filament sizes were increased until the first sensation was detected, and the initial detectable filament was recorded. A descending series was then applied to identify the smallest filament still perceived. This ascending-descending method was repeated five times, and the method of limits was used to determine thresholds. Standardized instructions: "With your eyes open, I will apply pressure using several filaments of varying stiffness. Some you may feel, others you may not. Then, with your eyes closed, please indicate each time you feel the stimulus. Close your eyes, and we will begin." | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Somatosensorial status (QST): MECHANICAL PAIN THRESHOLD (MPT) | Mechanical pain threshold was assessed using Von Frey filaments. Filaments were applied in ascending order until the participant first reported the sensation as painful. Then, a descending sequence identified the smallest filament still perceived as painful. The test was repeated five times, and the mean filament force (measured in grams) was recorded as the MPT. Standardized instructions: "You will feel a sharp stimulus. Please tell me when the sensation becomes uncomfortable but not yet painful-approximately 4 out of 10 on the Numerical Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain. Higher filament force indicates a higher pain threshold (less sensitivity)." | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Somatosensorial status (QST): PAIN FACILITATION | Temporal summation was evaluated using Von Frey filaments at the mechanical pain threshold. A single stimulus was applied to a fixed point, followed by a pain rating on the NRS (, 0-10). Then, 10 identical stimuli were delivered at a frequency of 1 Hz using a 60- bpm metronome. A second NRS score was collected immediately after. The procedure was repeated three times, and the average was used for analysis. Standardized instructions: "We will apply the same sharp stimulus used in the previous test. Please rate your pain intensity on a scale from 0 to 10, where 0 means no pain and 10 indicates the worst imaginable pain. Keep your eyes closed during the procedure. First, rate your pain after one stimulus, and then again after the sequence of ten." | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Somatosensorial status (QST): PRESSURE PAIN THRESHOLD (PPT) | Pressure pain threshold was measured using a digital algometer (Wagner Instruments FPX 100). With the patient in a supine position, incremental pressure was applied perpendicularly to the skin until pain was first perceived. Three measurements were obtained per site, and the average was used for analysis. Assessments were conducted at the primary painful area, the contralateral upper limb, and the anterior thigh of a pain-free lower limb. | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| Physical activity was assessed using the Global Physical Activity Questionnaire (GPAQ) | A self-reported instrument developed by the World Health Organization and validated for use in cancer populations and Spanish-speaking individuals. The GPAQ evaluates physical activity in three domains-occupational, transportation, and leisure-and also captures sedentary behavior, defined as daily time spent sitting or lying down, excluding sleep. Based on total activity scores, participants were classified as inactive (<100), mildly active (100-1951), moderately active (1952-5724), or vigorously active (≥5725) (Cleland et al., 2014). | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23). | This 23-item questionnaire includes four functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and four symptom scales (side effects of therapy, breast symptoms, arm symptoms, and distress from hair loss). Responses are given on a 4-point Likert scale ranging from 0 ("not at all") to 4 ("very much") | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| CARDIOPULMONARY FITNESS | Functional capacity was assessed using the Siconolfi Step Test, a validated submaximal test for estimating maximal oxygen uptake (VO₂max) in cancer populations. The test was performed on a 10-inch (25.4 cm) step in three 3-minute stages, with 1-minute rest intervals. Cadence was controlled via metronome at 68 bpm (stage 1), 104 bpm (stage 2), and 136 bpm (stage 3), corresponding to 17, 26, and 32 steps per minute, respectively. Heart rate was recorded at 2:30 minutes into each stage using a POLAR monitor. The test was terminated if participants experienced cardiorespiratory symptoms, musculoskeletal discomfort, peripheral fatigue, inability to maintain cadence, an RPE of 10, or if heart rate exceeded 65% of age-predicted maximum (220 - age). | Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |