NCT06291584

Brief Summary

In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity.

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 8, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

February 9, 2024

Last Update Submit

March 7, 2024

Conditions

Keywords

nicotine addictionrespiratory exercisetelehealthresistance exercise

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Study Arms (3)

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.

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.

Other: Exercise

Control Group

NO INTERVENTION

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

Interventions

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.

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, 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.

You may not qualify if:

  • The exercise sessions to be held on time and regularly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirklareli University

Kırklareli, Kayalı, 39000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tobacco Use DisorderRespiration DisordersSedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Burcu ÖZÜBERK, Assoc. prof.

    Kırklareli University

    PRINCIPAL INVESTIGATOR

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
First of all, the 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 three groups will be included in the group written in the envelope he selected.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
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 8, 2024

Record last verified: 2024-03

Locations