Exercise Intervention for Healthy Subjects (HS)

1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
+1 More
Exercise Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Healthy Subjects (HS)

Study Summary

This study is evaluating whether physical activity can help African Americans stop smoking.

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Eligible Conditions

  • Healthy Subjects (HS)
  • Current Smokers

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Exercise Intervention will improve 3 primary outcomes and 1 secondary outcome in patients with Healthy Subjects (HS). Measurement will happen over the course of 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 Estimate

1 of 3

Compared to trials

Trial Design

3 Treatment Groups

Arm III (no physical activity)
Arm II (quit day physical activity)

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. Exercise Intervention is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm II (quit day physical activity)Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning on the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise per week for 5 weeks.
Arm I (pre-quit physical activity)Participants receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks. Beginning 2 weeks before the assigned quit date, participants receive a Walking Program guide and engage in the SCwPA comprising brisk, self-paced walking with a goal of 150 minutes of exercise activity per week for 5 weeks.
Arm III (no physical activity)Participants quit smoking on an assigned date and receive telephone-based cessation counseling over 15-20 minutes 1-2 weeks before assigned quit date and nicotine patch for 6 weeks.
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

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 8 weeks for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Normal blood pressure is below 140/90 millimeters of mercury (mm Hg) show original
, even if you have quit If your carbon monoxide level is more than 8 parts per million, even if you have quit smoking, it is suggestive of current smoking. show original
Self-reported African-American race
A person who smokes ≥ 100 cigarettes in their lifetime and smokes ≥ 5 cigarettes per day for the last 6 months. show original
was associated with quit attempts People who said they were motivated to quit smoking within the next two weeks were more likely to try to quit smoking than those who were not motivated to quit. show original
The individual is willing to participate in a physical activity-based smoking cessation intervention. show original
The person has a home address and a functioning home and/or cell phone number. show original
The individual can participate in physical activity of moderate intensity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by a letter from a physician or nurse practitioner if currently taking medication for blood pressure or diabetes. show original
was similar between intervention and control groups, with nearly two-thirds of participants in each group willing to wear a patch for four weeks show original

Patient Q&A Section

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

How many people get healthy subjects (hs) a year in the United States?

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About 2.3 million US adults have an hs diagnosis at some point in their lifetime. This makes up 8.2% of the adult US population in 2005. There may be a similar prevalence of hs outside of the US, but this has not yet been documented.

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What causes healthy subjects (hs)?

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In a recent study, findings are consistent with the hypothesis that HSPs are characterized by changes in the microcirculation and vascular function, such as high vascular resistance. These changes should help explain the increased risk of cardiovascular diseases seen in HSPs.

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What are common treatments for healthy subjects (hs)?

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As of 2000, the treatments recommended for healthy subjects by the U.S. Preventive Services Task Force (USPSTF) are based on current evidence. The U.S. Preventive Services Task Force states that NSAIDs are effective for treating pain and inflammation, have no detrimental effect on bowel function, and are probably safe for people 65 years of age or older. NSAIDs are also effective for treating pain and inflammation in children who are older than 2 years of age. As of 2000 NSAIDs are usually recommended as the treatment for osteoarthritis by the USPSTF for up to 3 months, while other medications may be useful for pain relief when NSAIDs are no longer effective.

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What are the signs of healthy subjects (hs)?

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Healthy subjects usually have no complaints of low back pain or sciatica. The use of the SLS and the RMDQ helps us identify an asymptomatic cohort of healthy subjects with low back pain or sciatica.

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What is healthy subjects (hs)?

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Hs are a group of subjects that can be assessed as healthy in several domains of health. It is important to acknowledge and define the domains and their indicators because they are the focus of most studies where healthy subjects are needed. In a recent study, findings shows that the domains of health that are assessed can be very wide and varied and there are several ways of assessing them in different studies, and the results obtained can be different because different sets of domains are assessed in different studies.

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Can healthy subjects (hs) be cured?

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hs, as a model of prodromal symptoms, showed comparable disease burden with patients with early psychosis and can be considered for studies of early manifestation of psychotic symptoms.

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Has exercise intervention proven to be more effective than a placebo?

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The findings of this meta-analysis of randomized controlled trials do not support a benefit of exercise over a placebo for improving quality, duration, and magnitude of remission in psoriasis/atopic dermatitis.

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Have there been other clinical trials involving exercise intervention?

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Recent findings suggest that an increase of physical fitness was found to be associated with a reduction for body fatness and fat-free mass in obese adults, in addition to an overall improvement of metabolic syndrome features in a 6-months long follow-up. These effects were not related to changes in weight, physical activity or to changes in insulin sensitivity. Therefore, our data add further evidences that a higher number of aerobic exercises can improve metabolic features in a more efficient way compared to a lower or moderate number of aerobic exercises. More rigorous studies with longer follow-up will be necessary to confirm these findings.

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Does healthy subjects (hs) run in families?

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Findings from a recent study from this first linkage analysis on hs and their relatives, combined with previous studies by the MGI group, suggest a modest genetic contribution to healthy subjects' performance in cognitive test batteries.

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Have there been any new discoveries for treating healthy subjects (hs)?

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This book highlights the importance of studying hs. It contains a lot of information to help patients with HPV get all the information they need to make informed clinical decisions.

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What is exercise intervention?

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In a recent study, findings provides the first evidence that a physical training program incorporating a HIIT (high intensity interval training) protocol improves fat cell size in women. There is scope to identify physical activity regimes which are capable of altering fat cell size through improvements in cardiorespiratory capacity. A more controlled study will be required to evaluate whether HIIT can be applied as a training modality to attenuate the decline of cardiorespiratory fitness associated with ageing.

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