Exercise Intervention for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy Subjects (HS)+1 More
Exercise Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether physical activity can help African Americans quit smoking.

Eligible Conditions
  • Healthy Subjects (HS)
  • Current Smokers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Up to 8 weeks

Up to 8 weeks
Mechanisms underlying smoking cessation (e.g., stress, positive and negative affect, depression, smoking urges, self-efficacy, motivation, PA enjoyment, and heart rate variability)
Post intervention focus group analysis
Recruitment feasibility, defined as >= 75% of eligible/screened participants choose to enroll in the study
Retention feasibility, defined as an overall retention rate of 80% and if each enrolled participant completes >= 66.7% of study visits (>= 6 of 9 study visits)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Arm III (no physical activity)
1 of 3
Arm II (quit day physical activity)
1 of 3
Arm I (pre-quit physical activity)
1 of 3

Active Control

Experimental Treatment

45 Total Participants · 3 Treatment Groups

Primary Treatment: Exercise Intervention · No Placebo Group · N/A

Arm II (quit day physical activity)Experimental Group · 5 Interventions: Exercise Intervention, Nicotine Patch, Questionnaire Administration, Tobacco Cessation Counseling, Laboratory Biomarker Analysis · Intervention Types: Behavioral, Drug, Other, Other, Other
Arm I (pre-quit physical activity)Experimental Group · 5 Interventions: Exercise Intervention, Nicotine Patch, Questionnaire Administration, Tobacco Cessation Counseling, Laboratory Biomarker Analysis · Intervention Types: Behavioral, Drug, Other, Other, Other
Arm III (no physical activity)ActiveComparator Group · 4 Interventions: Nicotine Patch, Questionnaire Administration, Tobacco Cessation Counseling, Laboratory Biomarker Analysis · Intervention Types: Drug, Other, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2017
Completed Phase 4
~1810
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 weeks

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,993 Previous Clinical Trials
41,300,406 Total Patients Enrolled
61 Trials studying Healthy Subjects (HS)
25,329 Patients Enrolled for Healthy Subjects (HS)
M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,726 Total Patients Enrolled
8 Trials studying Healthy Subjects (HS)
2,638 Patients Enrolled for Healthy Subjects (HS)
Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
2,071 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to engage in moderate intensity physical activity as determined by the PAR-Q or by physicians clearance if currently taking medication for blood pressure or diabetes.
You have a home address and/or a cell phone number.
You have an expired CO level > 8 ppm suggestive of current smoking.
You have a blood pressure of 140/90mm Hg or higher.
You are willing to participate in a physical activity-based smoking cessation intervention.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
M D Anderson Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%