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Inspiratory Muscle Training for Breast Cancer Survivors with Obesity (IMOCS Trial)

N/A
Recruiting
Led By Dharini M Bhammar, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance
obese as defined by a body mass index (BMI) of 30 to 50 kg/m2 & nonobese as defined as BMI 18.5 to 24.9 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 16 weeks
Awards & highlights

IMOCS Trial Summary

This trial will test whether a specific type of exercise can help obese breast cancer survivors by improving their exercise tolerance.

Who is the study for?
This trial is for sedentary obese breast cancer survivors with a BMI of 30-50, who finished treatment for Stage 0-III cancer within the past 6 months to 5 years. Participants should have some exercise intolerance but can't join if they smoke, are pregnant/nursing, or have heart disease, severe joint issues, recent infections treated with antibiotics or steroids, or any psychiatric conditions that affect study compliance.Check my eligibility
What is being tested?
The trial is testing whether inspiratory muscle training improves exercise tolerance in these individuals compared to regular exercise training. It's a randomized controlled trial which means participants will be randomly assigned to one of the two interventions without choosing which one.See study design
What are the potential side effects?
While specific side effects aren't listed for inspiratory muscle training and exercise training in this context, general risks may include muscle soreness and fatigue. Exercise could exacerbate existing health problems if not done carefully under guidance.

IMOCS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do less than 90 minutes of moderate exercise weekly and struggle with some physical activities.
Select...
My BMI is either between 30 to 50 or 18.5 to 24.9.
Select...
My BMI is between 30 and 50.

IMOCS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in exercise tolerance
Secondary outcome measures
Change in dyspnea
Change in exercise capacity
Change in fatigue
+2 more

IMOCS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 4 wk IMT + 12 wk exerciseExperimental Treatment2 Interventions
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
Group II: 4 wk SHAM + 12 wk exercisePlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inspiratory muscle training
2018
Completed Phase 3
~760
Exercise training
2019
Completed Phase 1
~1110

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,665 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,089 Total Patients Enrolled
5 Trials studying Cancer Survivors
229 Patients Enrolled for Cancer Survivors
Dharini M Bhammar, PhDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Exercise training Clinical Trial Eligibility Overview. Trial Name: NCT05193149 — N/A
Cancer Survivors Research Study Groups: 4 wk SHAM + 12 wk exercise, 4 wk IMT + 12 wk exercise
Cancer Survivors Clinical Trial 2023: Exercise training Highlights & Side Effects. Trial Name: NCT05193149 — N/A
Exercise training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05193149 — N/A
Cancer Survivors Patient Testimony for trial: Trial Name: NCT05193149 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for participants to enroll in this scientific research?

"According to clinicaltrials.gov, this research study is not presently enrolling patients; the protocol was initially listed on July 1st 2023 and last updated October 31st 2022. Nevertheless, there are currently 3568 other trials that are actively recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
The Ohio State University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Have struggled with my weight since i was a kid and can never seen too loose it.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Inspiratory Muscle Training in Obese Breast Cancer Survivors
Dharini Bhammar 2023. "Inspiratory Muscle Training in Obese Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05193149.
~52 spots leftby Jun 2028
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