Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Respiratory Aspiration

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Respiration Disorders

Respiratory Tract Diseases

Esophageal Cancer

inspiratory muscle training will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable.

inspiratory muscle training

The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.

Background and Purpose: Incidence rates of esophageal cancer remain high in Eastern Asia. In 2012, esophageal cancer was the 9th leading cause of cancer deaths in Taiwan. Whether surgical resection is possible, combined modality therapy is usually required for the treatment of esophageal cancer. In clinical observation, patients underwent combined modality therapy usually demonstrated respiratory muscle dysfunction which might further impair physical activity and quality of life. The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.

Methods: This is a prospective interventional study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test). IMT will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable. Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.

Clinical relevance: The results of this study will help to better understand the clinical beneficial effects (e.g., better functional capacity) of an added inspiratory muscle training during combined modality therapy in patients with esophageal cancer.

Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy

Change from baseline MIP at the end of each week's CCRT treatment

Change from baseline MEP at the end of each week's CCRT treatment

Change from baseline EMGdi at the end of each week's CCRT treatment

Change from baseline FEV1 at the end of each week's CCRT treatment

Change from baseline FVC at the end of each week's CCRT treatment

Change from baseline 6-minute walking distance at the end of each week's CCRT treatment

Change from baseline Modified Borg Dyspnea score at the end of each week's CCRT treatment

Mackay Memorial Hospital

VS. Division of Radiation Oncology, Department of Radiology

Nutritional and Metabolic Diseases

Skin and Connective Tissue Diseases

Obesity

Breast Neoplasms

Breast Diseases

Skin Diseases

4 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity

4 weeks of SHAM training, 3/week, 3 sets of 15 repetitions, intensity up of 10% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity

Inspiratory muscle training

Exercise training

Dharini M Bhammar, PhD

Sagar Sardesai, MD

The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.

Randomized controlled trial (RCT) where obese participants (N=133) are randomized to 2 arms: \[i\] IMT 4 wks + Exercise 12 wks, \[ii\] SHAM 4 wks + Exercise 12 wks).

Staff completing outcomes testing and study participants will be blinded to treatment assignment (IMT/SHAM). The IMT/SHAM devices are the same with ability to alter resistance; however, upon use at the lower intensity, the participant may be able to tell whether the device has resistance.

Inspiratory Muscle Training in Obese Breast Cancer Survivors

Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer

We will make deidentified data freely available if requested. The privacy and rights of the participants will be protected.

Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.

Continuous variable, Maximal inspiratory pressure. Units: cm H20

Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min

Continuous variable, peak oxygen uptake. Units: L/min

Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4

Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52

Ohio State University Comprehensive Cancer Center

Assistant Professor

Dyspnea

Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.

Inspiratory muscle training will be performed using the POWERbreathe Plus IMT (POWERbreathe International Ltd., Warwickshire, UK), a commercially available inspiratory pressure threshold device. In this type of training, airflow is occluded until the generated inspiratory pressure reaches the predetermined threshold, which can be set at increments of 8 cm H2O.

During the first week of training, the target intensity will be set at 50% of baseline maximal inspiratory pressure (MIP.) During the second week, the target intensity will be set at 60% of baseline MIP. Beginning at the third week and for the remainder of the training program, the target intensity will be set at 75% of the participant's baseline MIP. The target volume will be 5 sets of 6 breaths per day (total of 30 breaths per day), separated by 1-minute rest breaks between sets. The frequency of training will be 5 days per week, for a duration of 6 weeks.

POWERbreathe Plus IMT

Martina Miller

Simon Ho

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in childhood cancer survivors.

During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Diaphragm Structure and Function in Childhood Cancer Survivors

Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Childhood Cancer Survivors (2373GCCC)

Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol

Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol

Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength

Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging

Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise

University of Maryland, Baltimore

Wounds and Injuries

Neoplasm Metastasis

Hyperthermia

Fever

Neoplastic Processes

Participants in the intervention group were using a handheld device, Powerbreathe K3, aiming at increasing inspiratory muscle strength by applying an inspiratory resistance. They were instructed to use it twice a day for at least 14 days. Starting load was based on the baseline assessment of the participant's inspiratory muscle strength and increased during the intervention period.

Participants in the control arm were instructed to use a handheld PEP-device traditionally used to facilitate deep breathing. The PEP-device does not provide any inspiratory resistance and therefore, it was considered a sham treatment. The control group were also instructed to use the device twice a day for at least two weeks.

Mini-PEP

Mikael Andersson, PhD

The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases.

The main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010.

Participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.

Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

Preoperative Inspiratory Muscle Training for Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - a Feasibility Study

De-identified data will be shared upon reasonable request.

Feasibility will be assessed using two domains: process and scientific feasibility. These domains include several parts such as recruitment rates, time available for training, intervention adherence, patient acceptability, pre-and postoperative respiratory muscle and lung function assessments, reproducibility of assessments, preliminary treatment effect, incidence of PPCs, and adverse events.

Uppsala University

Patients will start the IMT-R, following their consent and within 2 weeks of their scheduled surgery: 10 sessions lasting about 90 minutes. Participants who completed their initial IMT greater than 2 weeks prior to surgery will have an additional visit prior to surgery. Participants will receive a Participant Manual demonstrating and explaining the rehabilitation process. Participants will also receive a log for recording their efforts and notes. A DVD of the rehabilitation is available to the participant. Participants will complete questionnaires at baseline and 3 months.

The training will include the following components:

1. Breathing Awareness
2. Upper and Lower Extremity Exercise.
3. Instructions for Inspiratory Muscle Training (IMT) performed using the PFlex valve
4. Practice at home

Inspiratory Muscle Training-Rehabilitation

Patient quality of life will be measured using patient-reported outcomes measurement information system (PROMIS) global items. Patients will also complete the Chronic Respiratory Questionnaire (CRQ) and the Medical Research Council Dyspnea Scale (MCR).

Questionnaires

Roberto P Benzo

To obtain definitive evidence for the effectiveness of a short preoperative inspiratory muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical resection.

Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Length of hospital stay will be measured by participant monitoring while hospitalized until hospital discharge.

Quality of life will be assessed at baseline and at 3 months after hospital discharge by participant completion of the PROMIS Global 10.

To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pneumonia in patients that undergo an esophageal surgical resection. The investigators will consider the following as pneumonia: new infiltrate + either fever (\>38.5 C) and white cell count \>11,000 or fever and purulent secretions.

To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pulmonary complications in patients that undergo an esophageal surgical resection.The investigators will consider the following events as post-operative pulmonary complications: severe atelectasis (requiring bronchoscopy) and respiratory failure (intubation or prolonged mechanical ventilation (\>24hours).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy	NCT03099629	Esophageal Canc...	inspiratory mus...	20 Years -	Mackay Memorial Hospital
Inspiratory Muscle Training in Obese Breast Cancer Survivors	NCT05193149	Cancer Survivor... Obesity Breast Cancer	Inspiratory mus... Exercise traini...	18 Years -	Ohio State University Comprehensive Cancer Center
Diaphragm Structure and Function in Childhood Cancer Survivors	NCT06205251	Childhood Cance... Cancer Survivor...	POWERbreathe Pl...	6 Years - 12 Years	University of Maryland, Baltimore
Inspiratory Muscle Training in Obese Breast Cancer Survivors	NCT05193149	Cancer Survivor... Obesity Breast Cancer	Inspiratory mus... Exercise traini...	18 Years -	Ohio State University Comprehensive Cancer Center
Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases	NCT05665257	Peritoneal Meta...	Inspiratory mus... Mini-PEP	18 Years -	Uppsala University
Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery	NCT02843750	Cancer of Esoph... Cancer of the E... Esophageal Canc... Esophagus Cance... Esophagus Neopl... Neoplasms, Esop...	Inspiratory Mus... Questionnaires	40 Years - 99 Years	Mayo Clinic
Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy	NCT03099629	Esophageal Canc...	inspiratory mus...	20 Years -	Mackay Memorial Hospital

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