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The aim of this study is to determinate if therapeutic exercise with blood flow restriction (BFR) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (CIPN) comparing to usual care.
CIPN is a side effect of cancer therapies that nowadays has no solution, so our intention is to carry out a preventive therapy against the onset of CIPN. The nature of the studies that try to prevent is very diverse, but one of the wide tools is therapeutic exercise. In this case we intend to combine therapeutic exercise with BFR to obtain a pre-conditioning effect that protects intraepidermal fibers from exposure to the chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRESIONA | Experimental | An adapted therapeutic exercise program using blood flow restriction cuff perfomed during chemotherapy treatment. 24-36 sessions of 1 hour multimodal components: aerobic, strength and fascial release exercises. Frequency will be adapted to the recovery status of each patient. |
|
| Control group | No Intervention | Patients undergoing usual medical treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRESIONA | Other | Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported CIPN symptoms | Symptoms across to sensory, motor and automic domains will be measured using the questionnarie the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased symptom burden. | Change from Baseline to 12 weeks (after intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Breast cancer quality of life | assessed by European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased quality of life. | Change from baseline to 12 weeks (after intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Cantarero-Villanueva, PhD | Contact | 958248764 | irenecantarero@ugr.es |
| Name | Affiliation | Role |
|---|---|---|
| Irene Cantarero-Villanueva, PhD | Physical Therapy Deparment, Faculty of Health Sciences, University of Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada | Recruiting | Granada | 18016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35079838 | Derived | Lopez-Garzon M, Cantarero-Villanueva I, Legeren-Alvarez M, Gallart-Aragon T, Postigo-Martin P, Gonzalez-Santos A, Lozano-Lozano M, Martin-Martin L, Ortiz-Comino L, Castro-Martin E, Ariza-Garcia A, Fernandez-Lao C, Arroyo-Morales M, Galiano-Castillo N. Prevention of Chemotherapy-Induced Peripheral Neuropathy With PRESIONA, a Therapeutic Exercise and Blood Flow Restriction Program: A Randomized Controlled Study Protocol. Phys Ther. 2022 Mar 1;102(3):pzab282. doi: 10.1093/ptj/pzab282. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071075 | Small Fiber Neuropathy |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| CIPN severity |
assessed by clinical version of The Total Neuropathy Score. Each item is scored from 0 to 4, with the total score ranging from 0 to 24 points; a higher score indicates greater neuropathy severity. |
| Change from Baseline to 12 weeks (after intervention) |
| Quality of sleep | assessed by Pittsburgh Sleep Quality Index that is a self-rated questionnaire which assesses sleep quality and disturbances. The global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties. | Change from Baseline to 12 weeks (after intervention) |
| Mood Assessment | assessed by Scale for Mood Assessment. The scale tries to assess four moods; anxiety, angerhostility, sadness-depression, and happiness. Itd subscale is scory from 0 to 10, a higher score in the EVEA subscales would indicate that the respondent has a higher level of sad-depressed, anxious, angryhostile, and happy mood, respectively. | Change from Baseline to 12 weeks (after intervention) |
| Pain in hands and feet | assessed by visual analogue scale. From 0 to 10, a higher score is a worse subjective pain in hands and feet. | Change from Baseline to 12 weeks (after intervention) |
| Touch Detection Thresholds | assessed by Semmes-Weinstein filaments (SWMs) | Change from Baseline to 12 weeks (after intervention) |
| Handgrip strength test | assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan) | Change from Baseline to 12 weeks (after intervention) |
| General physical functioning and mobility | assessed by the 6 minutes walking test. A greater distance (meters) covered over 6 min indicates greater mobility and general functioning. | Change from Baseline to 12 weeks (after intervention) |
| Body composition | assesseb by bioimpedance (InBody) | Change from Baseline to 12 weeks (after intervention) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |