Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06419023
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-05-06
Brief Title:
Impact of Pilates Method on Myofascial Stiffness Cardiorespiratory Fitness and Quality of Life in Breast Cancer Women
Sponsor:
Poznan University of Physical Education
Organization:
Poznan University of Physical Education
Study Overview
Official Title:
Influence of Pilates Method Intervention on Changes in Myofascial Stiffness Cardiorespiratory Fitness and Quality of Life in Women With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The effectiveness of breast cancer treatment is quite well documented Still side effects can underpin other treatment-induced diseases such as osteopenia diabetes and especially cardiovascular dysfunction Therefore finding a method that could partly counteract these side effects and at the same time be implemented throughout treatment is a challenge for researchers
The main purpose of this experimental randomized control trial was to analyze the effect of the Pilates Method PM intervention on changing the myofascial stiffness along the thoracic and lumbar spine cardiorespiratory fitness and quality of life in women with breast cancer receiving aromatase inhibitor therapy The apllied procedure of 12 -week PM training included the training intervention based on hypothesis
PM reduces myofascial stiffness along the thoracic and lumbar spine of women with breast cancer receiving aromatase inhibitor therapy
PM improves the cardiorespiratory fitness of women with breast cancer receiving aromatase inhibitor therapy
PM improves the quality of life of women with breast cancer receiving aromatase inhibitor therapy
Possible practical applications include the domains of exercise medicine physical activity in cancer and public health
The main purpose of this experimental randomized control trial was to analyze the effect of the Pilates Method PM intervention on changing the myofascial stiffness along the thoracic and lumbar spine cardiorespiratory fitness and quality of life in women with breast cancer receiving aromatase inhibitor therapy The apllied procedure of 12 -week PM training included the training intervention based on hypothesis
PM reduces myofascial stiffness along the thoracic and lumbar spine of women with breast cancer receiving aromatase inhibitor therapy
PM improves the cardiorespiratory fitness of women with breast cancer receiving aromatase inhibitor therapy
PM improves the quality of life of women with breast cancer receiving aromatase inhibitor therapy
Possible practical applications include the domains of exercise medicine physical activity in cancer and public health
Detailed Description:
The trial was conducted by Poznan University of Physical Education in cooperation with UMP Poland
This design of trial assumed the parallel two-arm group prospective randomized controlled trial RCT comparing an exercises-based intervention experimental group to usual care and physical activity recommendation control group in women with breast cancer with perioperative hormonal treatment AIRandomization were performed as a simple randomization with a 11 allocation coin toss
All patients were assessed and recruited by two oncologists regarding eligibility to participate in the study
Before enrollment all participants were given detailed information about experiment procedures risks and benefits of the study and gave their written consent to participation The patients were informed at any stage of the project may resign from participation without having to give a reasonThe study was conducted in two stages Patient recruitment and data collection started in February 2022 The baseline assessment of patients is carried out two weeks before the start of PT intervention PT intervention lasted 12 weeks Post-intervention assessment is performed during two weeks after PT intervention Finally data reports collection and data preparation for analysis were completed in December 2023
Potential patients matching primary criteria underwent clinical laboratory EKG and echocardiographic follow-up assessment by cardiologist Clinical specialists eligible for the study provided information about the study and presented informed consent to patients The patients were referred for further study diagnostics after clinical qualification and signed written informed consent to the planned research
Together with oncologists the research group also included sports physiologists cardiologist certified Pilates teacher All participants were evaluated by same qualified personnel according to standardized test protocols and in the same conditions at baseline and after 12-week intervention Objective physical measurements were performed by trained and blinded assessors unaware of the assignment information
At the baseline and post training period were performed following assessments
anthropometrics using digital stadiometer
body composition tested by the dual X-ray absorptiometry method
bone mineral density tested by the dual X-ray absorptiometry method
questionnaire assessment of i quality of life using EORTC QLQ-C30 Questionnaire version 30 EORTC QLQ-BR23 Questionnaire Breast cancer module ii pain using Brief Pain Inventory Short Form Questionnaire iii level of physical activity using IPAQ Questionnaire
myofascial stiffness using myotonometr and a non-invasive shear-wave elastography examination
respiratory function measured with spirometric tests
cardiorespiratory fitness measured with i cardiopulmonary exercise test CPET on the treadmil ii metabolic response assessment with blood lactic acid concentration iii subjective rating of perceived exertion with the Borg 6-20 scale
vascular circulation indicators measured with the use of the Flow Mediated Skin Fluorescence
inflammatory hematological ratios were calculated based on hematological medical patients indicators
Patients characteristics has been completed by medical records and socio-demographic questionnaires
The supervised physical activity intervention using the Pilates Method 60min each session 2 sessions each week over 12 weeks was used in this study
In the study took part two groups - Exercise Group experimental group performing PM intervention and Usual-Care Group control group
The training program involved exercise performed on mats The subjects took part in a model training session during which all exercises were explained performance was discussed common mistakes were pointed out and efforts were made to maintain proper exercise intensity and muscle activation and relaxationThe model PM training sessions was consisted of
1 warm-up and respiratory exercises 5-10 min
2 mat Pilates exercises with the traditional Pilates repertoire basic beginner adapted for breast cancer patients needs and restrictions 40 min
3 cool down and endings exercises 5 min
4 session summary 2-3min The training program was supervised by the same specialist of PM
This design of trial assumed the parallel two-arm group prospective randomized controlled trial RCT comparing an exercises-based intervention experimental group to usual care and physical activity recommendation control group in women with breast cancer with perioperative hormonal treatment AIRandomization were performed as a simple randomization with a 11 allocation coin toss
All patients were assessed and recruited by two oncologists regarding eligibility to participate in the study
Before enrollment all participants were given detailed information about experiment procedures risks and benefits of the study and gave their written consent to participation The patients were informed at any stage of the project may resign from participation without having to give a reasonThe study was conducted in two stages Patient recruitment and data collection started in February 2022 The baseline assessment of patients is carried out two weeks before the start of PT intervention PT intervention lasted 12 weeks Post-intervention assessment is performed during two weeks after PT intervention Finally data reports collection and data preparation for analysis were completed in December 2023
Potential patients matching primary criteria underwent clinical laboratory EKG and echocardiographic follow-up assessment by cardiologist Clinical specialists eligible for the study provided information about the study and presented informed consent to patients The patients were referred for further study diagnostics after clinical qualification and signed written informed consent to the planned research
Together with oncologists the research group also included sports physiologists cardiologist certified Pilates teacher All participants were evaluated by same qualified personnel according to standardized test protocols and in the same conditions at baseline and after 12-week intervention Objective physical measurements were performed by trained and blinded assessors unaware of the assignment information
At the baseline and post training period were performed following assessments
anthropometrics using digital stadiometer
body composition tested by the dual X-ray absorptiometry method
bone mineral density tested by the dual X-ray absorptiometry method
questionnaire assessment of i quality of life using EORTC QLQ-C30 Questionnaire version 30 EORTC QLQ-BR23 Questionnaire Breast cancer module ii pain using Brief Pain Inventory Short Form Questionnaire iii level of physical activity using IPAQ Questionnaire
myofascial stiffness using myotonometr and a non-invasive shear-wave elastography examination
respiratory function measured with spirometric tests
cardiorespiratory fitness measured with i cardiopulmonary exercise test CPET on the treadmil ii metabolic response assessment with blood lactic acid concentration iii subjective rating of perceived exertion with the Borg 6-20 scale
vascular circulation indicators measured with the use of the Flow Mediated Skin Fluorescence
inflammatory hematological ratios were calculated based on hematological medical patients indicators
Patients characteristics has been completed by medical records and socio-demographic questionnaires
The supervised physical activity intervention using the Pilates Method 60min each session 2 sessions each week over 12 weeks was used in this study
In the study took part two groups - Exercise Group experimental group performing PM intervention and Usual-Care Group control group
The training program involved exercise performed on mats The subjects took part in a model training session during which all exercises were explained performance was discussed common mistakes were pointed out and efforts were made to maintain proper exercise intensity and muscle activation and relaxationThe model PM training sessions was consisted of
1 warm-up and respiratory exercises 5-10 min
2 mat Pilates exercises with the traditional Pilates repertoire basic beginner adapted for breast cancer patients needs and restrictions 40 min
3 cool down and endings exercises 5 min
4 session summary 2-3min The training program was supervised by the same specialist of PM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None