Nicotine AddictionNCT06291584
Effects of Exercises on Functional Capacity
A study testing Exercise in people with Nicotine Addiction and Respiratory Disease, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Addiction, Respiratory Disease, Sedentary Behavior
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signing the illuminated consent form, Being smoking at least 1 cigarette for the last 6 months, Not having orthopedic or neurological findings that can prevent the exercises included in the study, To have a low- to medium-level physical activity level, Not to have any lower respiratory infection in the last 3 months.
Who cannot join
- The exercise sessions to be held on time and regularly.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirklareli University
Kırklareli, Kayalı, 39000
Fulya DEMIRHAN, Res. Ass., +90-532-353-2208, fulyademirhan@klu.edu.tr
About this study
Official title: Effects of Strengthening and Respiratory Exercises on Face and Online on Functional Capacity
In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity.
Read the detailed description
The American Sports Medical Association has reported that a regular exercise program containing endurarans, strength, flexibility, and neuromotor exercise training is required in addition to daily life activities in order to maintain and develop general health. In addition to the increase in muscle strength with resistant exercises, durability and strength are also targeted. When performing resistant exercise, it is important to breathe correctly. The speed of the exercise and the movements are performed throughout the furnishing openness of the joint movement. The effects of exercise on being healthy and good are mentioned in the literature in detail. However, the effects of exercise on the respiratory functions and functional capacity of young people who smoke are not adequately defined. For this reason, the researchers plan to research the effects of strengthening and respiratory exercises on the face and online on functional capacity.
- Conditions
- Nicotine Addiction, Respiratory Disease, Sedentary Behavior
- Being tested
- Exercise
- Keywords
- nicotine addiction, respiratory exercise, telehealth, resistance exercise
- Medical subject headings
- Tobacco Use Disorder, Respiration Disorders, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
In the exercise program, the first 5 minutes are for heating, and the last 5 minutes are for cooling. In the exercise program, which is planned to last 40 minutes in total, respiratory exercises will be applied to heating and cooling peryotes. At the end of respiratory exercises, resistance exercise training will be started. 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, hip extrudy, squat, and cat-decrease. These exercises will be held once a week, 10 repetitions, 2 sets, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Exercise Group | Experimental | In the face-to-face exercise group called Group 1, students will apply an exercise program of respiratory exercises and resistance exercises with the physiotherapist. Receives: 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. Receives: Other: Exercise |
| Control Group | No intervention | In the control group called Group 3, students will not be given any exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire - Short Form
Validity and reliability work of the questionnaire in Turkey was conducted in 2010 by Sağlam and his friends. It has questions about the physical time spent in the last 7 days to learn about the physical activities of people in daily life.
Measured: Evaluation should be carried out before the start of exercise proggramme and 8 weeks after.
Six-Minute Walk Test- (6MWT)
It is a widely used test for evaluating the functional capacity of individuals. Individuals are asked to walk at normal walking speeds for six minutes in a flat corridor of thirty meters long with a start and end point. The distance where cases walk for 6 minutes is recorded in meters.
Measured: Evaluation should be carried out before the start of exercise proggramme and 8 weeks after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Oct 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of three groups. Groups to be formed: Group 1: face-to-face exercise group; Group 2: Online (Telehealth) Exercise Group; Group 3: Control Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Demirhan, Kırklareli University
- Investigators
- Burcu ÖZÜBERK, Assoc. prof., Principal investigator, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291584
- Sponsor's protocol ID
- P20230001
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strengthening and Respiratory Exercises on Face and Online on Functional Capacity
- ClinicalTrials.gov ID
- NCT06291584
- Acronym / sponsor ID
- P20230001
- Conditions
- Nicotine Addiction, Respiratory Disease, Sedentary Behavior
- Keywords
- nicotine addiction, respiratory exercise, telehealth, resistance exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity.
Detailed description
The American Sports Medical Association has reported that a regular exercise program containing endurarans, strength, flexibility, and neuromotor exercise training is required in addition to daily life activities in order to maintain and develop general health. In addition to the increase in muscle strength with resistant exercises, durability and strength are also targeted. When performing resistant exercise, it is important to breathe correctly. The speed of the exercise and the movements are performed throughout the furnishing openness of the joint movement. The effects of exercise on being healthy and good are mentioned in the literature in detail. However, the effects of exercise on the respiratory functions and functional capacity of young people who smoke are not adequately defined. For this reason, the researchers plan to research the effects of strengthening and respiratory exercises on the face and online on functional capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study consists of three groups. Groups to be formed: Group 1: face-to-face exercise group; Group 2: Online (Telehealth) Exercise Group; Group 3: Control Group
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Exercise Group | Experimental | Other: ExerciseIn the face-to-face exercise group called Group 1, students will apply an exercise program of respiratory exercises and resistance exercises with the physiotherapist. |
| Telehealth Exercise Group | Experimental | Other: ExerciseIn the online (telehealth) exercise group, group 2 will be applied by the students with the help of the physiotherapist. |
| Control Group | No intervention | –In the control group called Group 3, students will not be given any exercise program. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Signing the illuminated consent form, Being smoking at least 1 cigarette for the last 6 months, Not having orthopedic or neurological findings that can prevent the exercises included in the study, To have a low- to medium-level physical activity level, Not to have any lower respiratory infection in the last 3 months.
Key exclusion criteria (1 listed)
- The exercise sessions to be held on time and regularly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseIn the exercise program, the first 5 minutes are for heating, and the last 5 minutes are for cooling. In the exercise program, which is planned to last 40 minutes in total, respiratory exercises will be applied to heating and cooling peryotes. At the end of respiratory exercises, resistance exercise training will be started. 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, hip extrudy, squat, and cat-decrease. These exercises will be held once a week, 10 repetitions, 2 sets, for 8 weeks. | Other | Face-to-Face Exercise Group, Telehealth Exercise Group |
Primary outcome
International Physical Activity Questionnaire - Short Form
Time frame: Evaluation should be carried out before the start of exercise proggramme and 8 weeks after.
Validity and reliability work of the questionnaire in Turkey was conducted in 2010 by Sağlam and his friends. It has questions about the physical time spent in the last 7 days to learn about the physical activities of people in daily life.
Six-Minute Walk Test- (6MWT)
Time frame: Evaluation should be carried out before the start of exercise proggramme and 8 weeks after.
It is a widely used test for evaluating the functional capacity of individuals. Individuals are asked to walk at normal walking speeds for six minutes in a flat corridor of thirty meters long with a start and end point. The distance where cases walk for 6 minutes is recorded in meters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu ÖZÜBERK, Assoc. prof. principal investigator
Kırklareli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Nicotine Addiction and Respiratory Disease, run by Kırklareli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fulya DEMIRHAN, Res. Ass. (+90-532-353-2208, fulyademirhan@klu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire - Short Form (time frame: Evaluation should be carried out before the start of exercise proggramme and 8 weeks after.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.