Impact of Pilates Method on Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Breast Cancer Women

NCT06419023 | Completed DMC

• 1 other identifier: MTarnas_PhD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

Pilates Method; quality of life; myofascial stiffness; pain; cardiorespiratory fitness; inflammation; breast cancer; aromatase inhibitor

Outcome Measures

Primary Outcomes (27)

• Quality of life - Global Health Status

  Quality of life - Global Health Status (GHS) assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 7. A high score represents a high QoL (better outcome).

  before and after 12-week intervention

• Quality of life - Functional scores

  Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).

  before and after 12-week intervention

• Quality of life - Symptom scores

  Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology /problems (worse outcome).

  before and after 12-week intervention

• Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective)

  Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module). On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).

  before and after 12-week intervention

• Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss)

  Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module).On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology / problems (worse outcome).

  before and after 12-week intervention

• Subjective pain assessment - Pain Severity Total Score

  Pain Severity Total Score assessment with Brief Pain Inventory (short form) Questionnaire. Pain severity is measured by four items: worst pain, least pain, average pain in the last 24 h, and pain now. On the scale minimum value is 0 (no pain), maximum value is 10 (pain as as you can imagine).

  before and after 12-week intervention

• Subjective pain assessment - Pain Interference Total Score, Physical Interference, Affective Interference

  Pain Interference Total Score, Physical Interference, Affective Interference assessment with Brief Pain Inventory (short form) Questionnaire. The seven interference items (sleep disturbance, general activity, mood, work, relations with others, walking, and enjoyment of life) are assessed on a 0 to 10 scale, with 0 being "did not interfere" and 10 being "interfered completely".

  before and after 12-week intervention

• Subjective pain assessment - the extent of pain complaints

  The extent of pain complaints assessment with Brief Pain Inventory (short form) Questionnaire. Pointing out on the body diagram the places where the subject feels pain.

  before and after 12-week intervention

• Myofascial stiffness

  Myofascial stiffness (N/m) assessment using myotonometer, MyotonPro® .

  before and after 12-week intervention, before and after unit Pilates session

• Myofascial stiffness

  Assessment of myofascial stiffness (kPa) and (m/s) using a non-invasive shear-wave elastography examination AIXPLORER SuperSonic Imagine.

  before and after 12-week intervention

• Resting Vital Capacity

  Level of Resting Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

  before and after 12-week intervention

• Forced Vital Capacity

  Level of Forced Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

  before and after 12-week intervention

• Maximal Voluntary Ventilation

  Maximal Voluntary Ventilation (l/min). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

  before and after 12-week intervention

• Forced Expiratory Volume in the first second of expiration

  Forced Expiratory Volume in the first second of expiration in %. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

  before and after 12-week intervention

• Peak Expiratory Flow

  Peak Expiratory Flow (l/s). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany

  before and after 12-week intervention

• The modified Tiffeneau-Pinelli index

  The modified Tiffeneau-Pinelli index is Forced Expiratory Volume in 1 second/ Vital Capacity ratio (%). A ratio below 70% is typically indicative of obstructive lung disease. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

  before and after 12-week intervention

• absolute Oxygen Uptake

  Absolute Oxygen Uptake (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• relative Oxygen Uptake

  Relative Oxygen Uptake (l/min/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• Volume of carbon dioxide

  Volume of carbon dioxide (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• absolute Power Output

  Absolute Power Output (Watts) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• relative Power Output

  Relative Power Output (W/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• Power Output when respiratory ratio (RQ) equal 1

  Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• Ventilatory equivalent for carbon dioxide

  Ventilatory equivalent for carbon dioxide (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• Minute ventilation per carbon dioxide production VE/VCO2 slope

  Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

  before and after 12-week intervention

• Heart Rate

  Resting and maximal Heart Rate (beats/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while an walking test on the treadmill using a heart rate monitor.

  before and after 12-week intervention

• Blood Lactic Acid Concentration

  Metabolic response assessment with blood lactic acid concentration (mmol/l) are tasted before and after a cardiopulmonary exercise test (CPET) (Biosen C-line, EKF Diagnostics)

  before and after 12-week intervention

• Subjective rating of perceived exertion

  Borg 6-20 scale was applied to indicate the level of exertion by participant at maximal oxygen uptake /peak oxygen uptake workload during CPET. On the scale minimum value is 6 (no exertion at all), maximum value is 20 (maximal exertion).

  before and after 12-week intervention

Secondary Outcomes (30)

• Body Height

  before and after 12-week intervention

• Body Mass

  before and after 12-week intervention

• Total Body Mass

  before and after 12-week intervention, test conducted while fasting

• Bone Mass

  before and after 12-week intervention, test conducted while fasting

• Muscle Mass

  before and after 12-week intervention, test conducted while fasting

Other Outcomes (2)

• Clinical history

  before and after 12-week intervention

• Socio-demographic characteristics

  before 12-week intervention

Study Arms (2)

Exercises group (EG)

EXPERIMENTAL

The exercise group (EG) participated in supervised physical activity intervention using the Pilates Method (exercises on the mat, 60min each session, 2 sessions each week over 12 weeks) were administered by certified Pilates teacher.

Behavioral: supervised physical activity intervention using the Pilates Method (exercises on the mat)

Usual-Care Group (U-CG)

NO INTERVENTION

Patients in the U-CG were instructed to continue with their usual activities: a) to avoid changing their diet habits during intervention; b) being physically active as usual.

Interventions

supervised physical activity intervention using the Pilates Method (exercises on the mat) BEHAVIORAL

Each Pilates session was consisted of: a) introduction to the goal of training, familiarizing new skills (2-3 min); b) Pre-Pilates warm-up and respiratory exercises (5-10 min); c) mat Pilates exercises with the traditional Pilates repertoire: basic, beginner (40 min); d) cool down and endings exercises (5 min); e) session summary (2-3min). When required, exercises were adapted for breast cancer body needs and restrictions. Depending on the purpose of the exercise, different equipment was used (Pilates small ball 22 cm, Swiss ball, small massage balls, resistance band, towels, rollers, boxes, "Magic Circle").

Exercises group (EG)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women with invasive breast cancer
• stage of disease according to TNM classification I-III
• cancer with estrogen receptor expression in at least 10% of cell nuclei
• supplemental hormone therapy with an aromatase inhibitor used for at least 6 months
• performance status according to ECOG classification 0-1
• BMI of 18.5-30
• without chronic diseases affecting the limitation of the use of oncological treatment
• without contraindications to participation in group supervised Pilates classes
• participation in at least 17 of 24 classes according to the proposed schedule

You may not qualify if:

• invasive breast cancer stage IV according to TNM classification
• performance status according to ECOG classification 2-4
• unregulated hypertension
• unstable ischemic heart disease
• arrhythmia
• rheumatic diseases
• osteoporosis
• advanced osteoarthritis
• disease of rheumatic origin (AS, RA, fibromyalgia)
• pregnancy
• BMI \< 18.5 or above 30
• unregulated hypothyroidism/hyperthyroidism
• Criteria for drop out The criteria for discontinuing allocated interventions are as follows: 1) participant's voluntary withdrawal from the study; 2) worsening of oncological prognosis that prevents the continuation; 3) absence of training sessions due to unjustified reasons in the case of the PG (compliance below 70%).

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education

Poznan, Greater Poland Voivodeship, 60-871, Poland

Location

MeSH Terms

Conditions

Pain; Inflammation; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maria Tarnas, Master

  Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 17, 2024
• Study Start: February 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: December 15, 2023
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

PL (1)