Moderate-Intensity Exercise and Pain Sensitization in Breast Cancer Survivors: A Case-Based Study

NCT07128030 | Recruiting

• 1 other identifier: EDCM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exercise Training; Breast Cancer; Pain Management

Keywords

pain severity; pain sensibilization; quantitative sensory testing; physical activity

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

Secondary Outcomes (11)

• Brief Pain Inventory (BPI)

  Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.

• Numerical Rating Scale (NRS)

  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)

  Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.

• SENSORIMOTOR CHARACTERISTICS: HANDGRIP STRENGTH

  Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.

• Somatosensorial status (QST): MECHANICAL DETECTION THRESHOLD (MDT)

  Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.

Study Arms (2)

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.

Other: Exercise

Control Group

NO INTERVENTION

Participants maintained usual activities for five weeks without changing exercise habits. No additional interventions (drugs, devices, or procedures) were applied.

Interventions

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.

Moderate-Intensity Exercise

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Bilateral breast cancer
• Locoregional recurrence
• Other malignancies
• Pre-existing pain not related to cancer treatment
• Neurological or cognitive disorders
• Non-Spanish speakers
• Contraindications to moderate-intensity physical activity

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Hospital General Universitario Gregorio Marañon: collaborator

Study Sites (1)

Universidad Rey Juan Carlos

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Agnosia; Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 17, 2025
• Study Start: August 23, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)