Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-28 @ 5:41 AM
Study NCT ID:
NCT01401569
Status:
TERMINATED
Last Update Posted:
2016-06-01
First Post:
2011-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Exercise and Counseling Intervention on Relapse in Smoker With Depressive Disorders
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties for recruiting patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOB-ACTIV
Brief Summary:
This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of intervention: individually delivered exercise and counseling (for smoking cessation and physical activity) or control: health education contact control condition.
Detailed Description:
This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of group delivered exercise and counseling (for smoking cessation and physical activity) or a health education contact control condition. The investigators assess this intervention in a randomized controlled trial of 96 depressed adults smokers recruited by advertisements in local print allocated into one of the two groups (intervention group vs. control group) during a 8-week period and 3 follow-up visits (12, 24, 52 weeks after baseline). All subjects (intervention and control groups) participate in a smoking cessation program composed of a pharmacological treatment (including nicotine replacement therapy or varenicline) and counseling.Experimental group subjects were required to attend 2 supervised exercise sessions and 2 counseling sessions during Week 1 and Week 2. Supervised exercise and counseling sessions are realized successively. For Week 3 to 8, participants were required to attend 1 supervised exercise session and 1 counseling session plus 1 home exercise session.Supervized exercise session consist of 5-min warm-up, 30 min of aerobic activity (stationary bikes), and a 5-min cooldown with stretching. The training intensity is of 60 to 80% maximum heart rate. The sessions are supervised by an exercise specialist who verified and documented the heart rates. Home exercise session consist of 45 min of aerobic exercise (walking, cycling, or running). The training intensity is 6 to 7 on breathlessness visual analog scale.The smoking counseling sessions included the following components: review of a participant's smoking history and motivation to quit, help in the identification of high-risk situations, management of cigarette craving and the generation of problem-solving strategies to deal with such situations.Exercise counseling sessions designed to motivate increased regular physical activity and short bouts of exercise in response to negative affect and urges to smoke. The goal of this intervention was to increase activity level.Health education group subjects were required to participate 75-minute supervised sessions with the same frequency of experimental group. Participants in the health education condition received information on a variety of health topics including sleep hygiene, nutrition, stress and health screening tests for cancer prevention. Participants were also asked to read handouts on health education topics covered during the session.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| n°ID RCB 2010-A00119-30 | OTHER | Afssaps - French Health Products Safety Agency | View |