Moderate-Intensity Exercise and Pain Sensitization in Breast Cancer Survivors: A Case-Based Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adherence by Tolerance: number of participants completing at moderate intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exercise (Other)
Control Group
Participants maintained usual activities for five weeks without changing exercise habits. No additional interventions (drugs, devices, or procedures) were applied.
结局指标
主要结局
Adherence by Tolerance: number of participants completing at moderate intensity
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Tolerance: number of progressions during the program
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Tolerance: number of incomplete sessions
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Tolerance: number of sessions at moderate intensity
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Tolerance: final progression level reached
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Motivation: number of absences
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Motivation: percentage of sessions recovered after absence
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Motivation: number of dropouts
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Motivation: number of presence of positive sensations
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
Adherence by Motivation: number of occurrence of adverse effects
时间窗: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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.
次要结局
- 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.)
- Somatosensorial status (QST): PRESSURE PAIN THRESHOLD (PPT)(Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.)
- Brief Pain Inventory (BPI)(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.)
- Somatosensorial status (QST): MECHANICAL PAIN THRESHOLD (MPT)(Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.)
- Somatosensorial status (QST): PAIN FACILITATION(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)(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).(Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.)
- CARDIOPULMONARY FITNESS(Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.)
研究者
DeAsís-Fernández, Francisco
Director
Universidad Rey Juan Carlos