Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
inspiratory muscle training
Sponsored by
About this trial
This is an interventional prevention trial for Esophageal Cancer focused on measuring Inspiratory muscle training, Diaphragmatic surface electromyography, Respiratory muscle strength, Functional capacity
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed primary esophageal cancer, aged more than 20 years, communicate without difficulty.
Exclusion Criteria:
- inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy.
Sites / Locations
- Mackay Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMT
Arm Description
inspiratory muscle training
Outcomes
Primary Outcome Measures
Changes of maximal inspiratory pressure (MIP)
Change from baseline MIP at the end of each week's CCRT treatment
Changes of maximal expiratory pressure (MEP)
Change from baseline MEP at the end of each week's CCRT treatment
Changes of diaphragmatic surface electromyography (EMGdi)
Change from baseline EMGdi at the end of each week's CCRT treatment
Changes of forced expiratory volume in one second (FEV1)
Change from baseline FEV1 at the end of each week's CCRT treatment
Changes of forced vital capacity (FVC)
Change from baseline FVC at the end of each week's CCRT treatment
Secondary Outcome Measures
Changes of functional exercise capacity using 6-minute walking distance
Change from baseline 6-minute walking distance at the end of each week's CCRT treatment
Changes of dyspnea using Modified Borg Dyspnea score
Change from baseline Modified Borg Dyspnea score at the end of each week's CCRT treatment
Full Information
NCT ID
NCT03099629
First Posted
March 14, 2017
Last Updated
March 31, 2017
Sponsor
Mackay Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03099629
Brief Title
Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy
Official Title
Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Inspiratory muscle training, Diaphragmatic surface electromyography, Respiratory muscle strength, Functional capacity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMT
Arm Type
Experimental
Arm Description
inspiratory muscle training
Intervention Type
Behavioral
Intervention Name(s)
inspiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of maximal inspiratory pressure (MIP)
Description
Change from baseline MIP at the end of each week's CCRT treatment
Time Frame
Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Title
Changes of maximal expiratory pressure (MEP)
Description
Change from baseline MEP at the end of each week's CCRT treatment
Time Frame
Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Title
Changes of diaphragmatic surface electromyography (EMGdi)
Description
Change from baseline EMGdi at the end of each week's CCRT treatment
Time Frame
Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Title
Changes of forced expiratory volume in one second (FEV1)
Description
Change from baseline FEV1 at the end of each week's CCRT treatment
Time Frame
Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Title
Changes of forced vital capacity (FVC)
Description
Change from baseline FVC at the end of each week's CCRT treatment
Time Frame
Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Secondary Outcome Measure Information:
Title
Changes of functional exercise capacity using 6-minute walking distance
Description
Change from baseline 6-minute walking distance at the end of each week's CCRT treatment
Time Frame
Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
Title
Changes of dyspnea using Modified Borg Dyspnea score
Description
Change from baseline Modified Borg Dyspnea score at the end of each week's CCRT treatment
Time Frame
Baseline and weekly during CCRT treatment (for a total of 4-5 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly diagnosed primary esophageal cancer, aged more than 20 years, communicate without difficulty.
Exclusion Criteria:
inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy.
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
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Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy
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