NCT06291558

Brief Summary

Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 9, 2024

Last Update Submit

February 26, 2024

Conditions

Keywords

resistance exerciserespiratory exercisenicotine addictionrespiratory function testtelehealth

Outcome Measures

Primary Outcomes (5)

  • International Physical Activity Questionnaire (Short)

    It contains questions about the physical time spent in the last 7 days to learn about the physical activities of people in daily life. Metabolic equivalent (met) method was used to determine the level of physical activity. Standard Met values have been created for these activities. The daily and weekly physical activity level of the individual will be calculated by using the metal values determined for severe physical activity, moderate severe physical activity, walking and sitting.

    Evaluation should be carried out before the start of treatment and 8 weeks after treatment.

  • Six-Minute Walk Test

    It is a widely used test for evaluating the functional capacity of individuals. Individuals shall be requested to walk at normal walking speeds in a flat corridor of thirty meters long, with the start and end points determined for six minutes, and the distance in which the cases walk for six minutes shall be recorded in meters.

    Evaluation should be carried out before the start of treatment and 8 weeks after treatment.

  • Scoring the Fagerstrom Test for Nicotine Dependence (FTND)

    It is used to measure nicotine addiction. Points obtained from the scale, nicotine addiction level 0-2 Points: Very low level of nicotine addiction 3-4 points: low level of nicotine addiction, 5 points: moderate nicotine addiction, 6-7 points: high level of nicotine addiction, 8-10 points 8-10 points : It is classified as a very high level of nicotine addiction

    Evaluation should be carried out before the start of treatment and 8 weeks after treatment.

  • Beck's Depression Inventory (BDI)

    It is a scale applied to determine whether the person shows signs of depression. The scale consists of 21 items, and eleven items are divided into cognitions, two substances, two substances, five substances, physical symptoms, and one substance for individual symptoms. Each question is given to 0, 1, 2, or 3, and the patients are asked to choose the most appropriate one of these questions. A score between 0-63 is obtained. 0-9 no/minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.

    Evaluation should be carried out before the start of treatment and 8 weeks after treatment.

  • Lung Function Test

    It allows the measurement of spirometry and pulmonary functions and the determination of abnormalities in the respiratory system. Spirometry shows the values obtained by exhalation and inhalation of air volumes during compulsory maneuvers. The main spirometry parameters are vital capacity (VC), challenging vital capacity (FVC), challenging expiratory volume in the first second (Fev1), and these parameters (Fev1/VC, Fev1/FVC).

    Evaluation should be carried out before the start of treatment and 8 weeks after treatment.

Study Arms (3)

Face to face Exercise Group

EXPERIMENTAL

In the face-to-face exercise group called Group 1, students will implement an exercise program of respiratory exercises and resistance exercises with the physiotherapist. Exercises will be held for 8 weeks

Other: Exercise

Telehealth Exercise Group

EXPERIMENTAL

In the online (telehealth) exercise group, group 2 will be applied by the students with the help of the physiotherapist. Exercises will be held for 8 weeks

Other: Exercise

Control Group

NO INTERVENTION

In the control group called Group 3, students will not be given any exercise program.

Interventions

The first 5 minutes of heating in the exercise program are planned to be implemented for 8 weeks, and the last 5 minutes are a cooling period. In the exercise program, which is planned to last 40 minutes in total, respiratory exercises will be applied to heating and cooling peryotes. As respiratory exercise, diaphragmatic respiratory exercise will be applied to heating and cooling peryots with 5 repetitions. Elastic resistant bands (Therand) will be used in resistant exercise training that will last for 30 minutes. The participants will be started to work with the resistance that they can do 10 again but cannot reach 14 repetitions. Elastic resistant bands are shoulder flexion, shoulder extension, shoulder ablution, shoulder horizontal abduction, elbow extension, hip ablution, hip flexion, and hip exercise. These exercises will be held once a week, 10 repetitions, 2 sets, for 8 weeks.

Face to face Exercise GroupTelehealth Exercise Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signing the illuminated consent form,
  • To be smoking at least 1 cigarette a day for the last 6 months,
  • Not having orthopedic or neurological findings that can prevent the exercises included in the study,
  • To have low-medium level physical activity level,
  • Not to have any lower respiratory infection in the last 3 months.

You may not qualify if:

  • To the exercise sessions to be held on time and not to arrive regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirklareli University

Kırklareli, Kayalı, 39000, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Uysal MA, Kadakal F, Karsidag C, Bayram NG, Uysal O, Yilmaz V. Fagerstrom test for nicotine dependence: reliability in a Turkish sample and factor analysis. Tuberk Toraks. 2004;52(2):115-21.

    PMID: 15241694BACKGROUND
  • American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.

  • Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549.

MeSH Terms

Conditions

Tobacco Use DisorderSmokingSedentary BehaviorDepression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Fulya DEMIRHAN, Res. Ass.

CONTACT

Burcu ÖZÜBERK, Assoc.prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will be informed that the study was carried out for scientific purposes and the information will not be shared with third parties. Randomization of exercise groups will be performed according to the closed envelope procedure. The student who selects one of the envelopes with the names of the 3 groups will be included in the group written in the envelope he selected. Information about other groups will not be shared.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 9, 2024

First Posted

March 4, 2024

Study Start

October 1, 2023

Primary Completion

May 1, 2024

Study Completion

October 1, 2024

Last Updated

March 4, 2024

Record last verified: 2024-02

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