NCT01951456

Brief Summary

The purpose of this study is to determine whether resistance training can aid smoking cessation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

March 20, 2020

Status Verified

April 1, 2018

Enrollment Period

5.4 years

First QC Date

September 10, 2013

Last Update Submit

March 19, 2020

Conditions

Keywords

Smoking cessationresistance training

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    Salivary cotinine-verified 7-day Point Prevalence Abstinence (7-day PPA) from nicotine (cigarette smoking).

    Change from baseline to 3 months

Secondary Outcomes (15)

  • Cortisol

    3, 6, 12 months

  • Mood

    3, 6, 12 months

  • Cigarette cravings

    3, 6, 12 months

  • Abstinence self-efficacy

    3, 6, 12 months

  • Sleep

    3, 6, 12 months

  • +10 more secondary outcomes

Study Arms (2)

Resistance training

EXPERIMENTAL

Participants will attend two, 45-60-minute progressive, moderate intensity resistance training sessions per week for 12 weeks. The program will maintain a format of a 5-minute warm-up, 35-50 minutes of resistance training and a 5-minute cool-down with flexibility and abdominal exercises.

Behavioral: Resistance training

Health and Wellness

ACTIVE COMPARATOR

Participants in this group will be required to attend the exact same number of sessions as those in the Resistance Training group. Each session will last approximately 45-60 minutes. Sessions will include a practical component/demonstration, an informational video, and a handout on a pertinent healthy lifestyle topic for adults.

Behavioral: Health and Wellness

Interventions

Resistance training
Health and Wellness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older, smoke five or more cigarettes a day for at least the past 12 months

You may not qualify if:

  • Participating in any type of exercise for \>60 minutes/week over the past 3 months, current smokeless tobacco use, participation in an ongoing effort to quit smoking, current or planned pregnancy, any serious medical condition that would make exercise unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Interventions

Resistance TrainingHealth

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 26, 2013

Study Start

November 1, 2013

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

March 20, 2020

Record last verified: 2018-04

Locations