Increasing Physical Activity as Part of a Smoking Cessation Program

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The registry classes the interventions as behavioral and drug.

More on the Plan

However, past studies on this topic have consisted of highly structured, supervised physical activity, which made study recruitment and long-term adherence difficult.

Additionally, these studies generally have had low long-term quit rates, which may be attributed to the lack of a nicotine replacement component.

This 7-week study will enroll sedentary or minimally active cigarette smokers.

All participants will take part in a behavioral smoking cessation program and will wear a nicotine patch.

Who Took Part

The registry lists 400 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Smokes five or more cigarettes each day in the year prior to study entry. Sedentary or minimally active physical activity level. Willing to be randomly assigned to either intervention group. Willing to use the nicotine patch.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: pregnant, breastfeeding, or planning to become pregnant in the year following study entry; planning to move out of the area in the year following study entry; symptomatic peripheral artery disease.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Smoking status (measured immediately post-intervention and at 6- and 12-month follow-up visits).

It also tracked 4 secondary outcomes, for example Changes in self-reported and objective physical activity, Body mass index, Percentage of body fat and Waist circumference (all measured immediately post-intervention and at 6- and 12-month follow-up visits).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 400 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.