Moderate-Intensity Exercise and Pain Sensitization in Breast Cancer Survivors: A Case-Based Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversidad Rey Juan Carlos
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult women diagnosed with stage I-III breast cancer
Completion of active treatment (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior to enrollment
Presence of persistent pain or altered sensation in the upper quadrant of the affected limb related to oncologic treatment
Disqualifiers
Bilateral breast cancer
Locoregional recurrence
Other malignancies
Pre-existing pain not related to cancer treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionThe 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.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Moderate-Intensity ExerciseExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.2
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.
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.3
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.
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.4
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.
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.Secondary outcomes
1
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
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.2
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)
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.3
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
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.4
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.
Time frame
Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.Sponsors and contacts
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Universidad Rey Juan Carlos
Lead sponsor
Hospital General Universitario Gregorio Marañon
Collaborator
Source ClinicalTrials.gov