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

NCT ID: NCT07128030

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-23

Study Completion Date

2026-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise Training Breast Cancer Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Moderate-Intensity Exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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DeAsís-Fernández, Francisco

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Rey Juan Carlos

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Francisco Fernández, PhD

Role: primary

916 65 50 60

Other Identifiers

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EDCM

Identifier Type: -

Identifier Source: org_study_id

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