Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
NCT ID: NCT03469271
Last Updated: 2023-09-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
63 participants
INTERVENTIONAL
2018-05-25
2020-05-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Resistance Inspiratory Muscle Training for Patients With Thoracic Malignancies
NCT03834116
Rapid Easy Strength Training (REST) to Improve Function in Late Stage Cancer
NCT01334983
Effects of Inspiratory Muscle Training After Lung Cancer Surgery, a Randomized Controlled Trial
NCT01793155
Inspiratory Muscle Training on Respiratory Muscle Function，Quality of Life and Exercise Capacity in Stable COPD
NCT03101774
Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
NCT02843750
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Training and Placebo
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
Inspiratory isometric resistance training
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).
Oral Placebo
Placebo will be created to mimic the appearance of the study drug
Threshold Inspiratory Muscle Trainer (IMT)
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Sham Training and Vitamin D3 Metabolite
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
1,25 (OH)2 D3
0.25 micrograms, taken daily for eight weeks, orally
Sham Inspiratory Isometric Resistance Training
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.
Threshold Inspiratory Muscle Trainer (IMT)
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Training and Vitamin D3 Metabolite
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks
1,25 (OH)2 D3
0.25 micrograms, taken daily for eight weeks, orally
Inspiratory isometric resistance training
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).
Threshold Inspiratory Muscle Trainer (IMT)
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Sham Training and Placebo
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
Oral Placebo
Placebo will be created to mimic the appearance of the study drug
Sham Inspiratory Isometric Resistance Training
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.
Threshold Inspiratory Muscle Trainer (IMT)
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
1,25 (OH)2 D3
0.25 micrograms, taken daily for eight weeks, orally
Inspiratory isometric resistance training
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).
Oral Placebo
Placebo will be created to mimic the appearance of the study drug
Sham Inspiratory Isometric Resistance Training
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.
Threshold Inspiratory Muscle Trainer (IMT)
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Renal and hepatic function (creatinine \</= 2 x the institutional upper limit of normal; bilirubin \</= 2 x the institutional upper limit of normal)
* No contraindication to receive either of the planned interventions of inspiratory resistance training or 1,25(OH)2D3 in the opinion of the healthcare provider
* No difficulties with swallowing oral medications in the opinion of the enrolling physician
Exclusion Criteria
* Severe chronic obstructive pulmonary disease (oxygen dependent or patient self-reports unable to walk one block without difficulty)
* Calcium or phosphorus level above the institutional upper limit of normal
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Andersen Foundation
OTHER
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aminah Jatoi
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-009440
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.