Qigong and Multicomponent Exercise in Panic Disorder
Investigation of the Effects of Qigong Exercise Training and Multicomponent Exercise Training on Physical and Mental Health in People With Panic Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Izmir, Turkey (Türkiye)
- Recruiting
- Dokuz Eylul University
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Contact:
- Dokuz Eylul University Faculty of Physical Therapy
- Phone Number: +902324124901
- Email: fiziktedavi@deu.edu.tr
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between the ages of 18-65
- Being diagnosed with "panic disorder" by a psychiatrist
- Not having another psychiatric illness
- Wanting to participate in the research voluntarily and signing the informed consent
- Not having a history of communication or neuromusculoskeletal disease that would not allow the application of evaluation and treatment methods
Exclusion Criteria:
- Having a vision and/or hearing problem that would prevent participation in the study
- History of neurological, cardiopulmonary and musculoskeletal system disease that would negatively affect participation in evaluation and treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Qigong-Baduanjin Exercise Training Group
In our study, the Qigong exercise training group will receive Baduanjin training via online platform for 8 weeks, 2 days a week, 1 hour a day, under the supervision of a physiotherapist.
Each lesson will consist of 10 minutes of warm-up, 40 minutes of Qigong Baduanjin exercises, and 10 minutes of cool-down.
First, the participants will be taught isometric and isotonic segmental movement sequences in the upper and lower extremities, then they will be taught to combine breathing techniques, and then they will be taught to focus their attention on movement, breathing, and Qi (life force).
In addition, the patients will be asked to exercise at home unsupervised for 1 day a week and keep an exercise diary.
According to the participant's compliance and problems, examinations will be made in weekly check-ups and the exercise diary recorded by the patients will be checked, and thus exercise progressions will be ensured.
The sessions will be carried out in groups and supervised.
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Exercise training for 8 weeks
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Experimental: Multicomponent Exercise (resistance, balance, endurance and cognitive-motor skills) Training Group
Participants in this group will receive multicomponent exercise training via online platform, 2 times a week, 1 hour per day, for 8 weeks.
In addition, patients will be asked to exercise at home unsupervised for 1 day a week and keep an exercise diary.
Participant's compliance and problems will be examined during weekly check-ups, and exercise progressions will be provided by increasing the intensity according to the participant's compliance.
Sessions will be performed and supervised in groups.
The multicomponent exercise intervention will consist of a combined training program with three components (resistance training with "elastic resistance band", balance training, endurance and training to develop cognitive-motor skills (dual task)).
Each session will have a 3-part structure (warm-up, main exercise and cool-down) to increase the level of difficulty and commitment, and progress will be monitored throughout the 8-week multicomponent treatment.
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Exercise training for 8 weeks
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No Intervention: Wait List - Control Group
Participants in this group will only be monitored during the study, they will continue their normal treatments, in addition to their usual medical care, if they have a sports or exercise program, they will be asked to continue but not to start a new program, and they will be informed about healthy lifestyle recommendations (regular physical activity-exercise, nutrition, sleep, etc.).
In this group with a waiting list structure, individuals who have completed the study follow-up period will be offered exercise program options and will be included in the training programs if they want to participate in exercise training, but the data of these participants will not be included in the analyses of this study.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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DSM-5 Panic Disorder Severity Scale
Time Frame: change from baseline to 8 weeks
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Panic levels will be evaluated with the DSM-5 Panic Disorder Severity Scale.
It provides a five-point Likert-type rating (0=never, 1=sometimes, 2=half of the time, 3=most of the time, 4=all of the time).
Scores obtained from the scale items determine the severity of panic disorder.
The total score for the scale ranges from 0 to 40, with higher scores indicating more severe panic disorder symptoms.
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change from baseline to 8 weeks
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State-Trait Anxiety Inventory
Time Frame: change from baseline to 8 weeks
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State and trait anxiety levels will be assessed with the State-Trait Anxiety Inventory.
The State-Trait Anxiety Inventory is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale.
The STAI measures two types of anxiety separately in two forms (STAI-S; STAI-T)-state anxiety and trait anxiety.
The scale has 20 state-domain and 20 trait-domain questions.
A score of 1 indicates that the situation described in the question does not reflect their personality at all; a score of 4 indicates that the situation described in the question reflects their personality completely.
Each form is scored between 20 and 80, with higher scores positively correlated with higher anxiety levels, while lower scores indicate lower anxiety levels.
The cutoff score for this scale is 44, with scores of 45 and above indicating higher anxiety levels.
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change from baseline to 8 weeks
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mini-Balance Assessment Systems Test
Time Frame: change from baseline to 8 weeks
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The Mini-Balance Assessment Systems Test will be used for clinical balance assessment.
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change from baseline to 8 weeks
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Functional Walking Assessment
Time Frame: change from baseline to 8 weeks
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Functional Walking Assessment will be used to assess postural stability and balance during various walking tasks.
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change from baseline to 8 weeks
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Activity-Specific Balance Confidence Scale
Time Frame: change from baseline to 8 weeks
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Activity-Specific Balance Confidence Scale will be used to evaluate functional balance-mobility-walking performance.
For each question, the score ranges from 0% (no confidence) to 100% (full confidence).
The values across all activities are summed and the average calculated.
Measurement results range from 0% to 100%, with a higher average score indicating higher confidence.
A score above 80% on this scale indicates that the balance is reliable.
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change from baseline to 8 weeks
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5-Repetition Sit-to-Stand Test
Time Frame: change from baseline to 8 weeks
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The 5-Repetition Sit-to-Stand Test will be used to measure overall stability and functional lower extremity muscle strength.
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change from baseline to 8 weeks
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Sedentary Behavior Questionnaire
Time Frame: change from baseline to 8 weeks
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The Sedentary Behavior Questionnaire is a questionnaire developed to assess the time spent performing 11 sedentary behaviors on a typical weekday and weekend day.
The questionnaire has nine response options: "Never," "15 minutes or less," "30 minutes," "1 hour," "2 hours," "3 hours," "4 hours," "5 hours," and "6 hours or more."
Before scoring, the time spent on each behavior is converted to hours (for example, a 15-minute response is recorded as 0.25 hours).
For a total score, the behavioral durations in hours are summed separately for weekdays and weekends.
To obtain the average sedentary behavior duration for weekdays and weekends, the total time spent during the week is multiplied by 5, and the total time spent on weekends is multiplied by 2. When calculating the total time spent on sedentary behavior during the weekdays and weekends, scores higher than 24 hours/day are reduced to 24 hours/day and recorded.
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change from baseline to 8 weeks
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Baecke Habitual Physical Activity Questionnaire
Time Frame: change from baseline to 8 weeks
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The Baecke Habitual Physical Activity Questionnaire will assess participant's habitual physical activities over the last 12 months.
This questionnaire consists of 16 questions regarding three main areas of individual physical activity in the last 12 months: occupational (items 1-8), sports (items 9-12), and recreational (items 13-16).
Scores for each area range from 1 to 5; higher scores indicate higher physical activity.
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change from baseline to 8 weeks
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Exercise Benefits/Barriers Scale
Time Frame: change from baseline to 8 weeks
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The Exercise Benefits/Barriers Scale will be used to measure the perceived benefits of exercise and the perceived barriers to exercise.
Each participant will be asked to rate perceived benefits and perceived barriers on a 4-point Likert scale ("Strongly Agree," "Agree," "Disagree," and "Strongly Disagree").
Possible scores on the benefits scale range from 29 to 116, with higher scores indicating greater perceived benefits.
Possible scores on the barriers scale range from 14 to 56, with higher scores indicating greater perceived barriers.
The total score ranges from 43 to 172.
The higher the score, the more positively perceived physical activity benefits are relative to physical activity barriers.
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change from baseline to 8 weeks
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Montreal Cognitive Assessment Scale
Time Frame: change from baseline to 8 weeks
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Cognitive functions will be assessed with the Montreal Cognitive Assessment Scale.
The scale, which can be administered quickly, presents the individual with eight different cognitive tasks.
Developed to assess mild cognitive impairments, this scale assesses various cognitive abilities, including executive functions, visual-spatial skills, memory, language, attention and concentration, abstract thinking, calculation, and orientation.
The maximum score possible from the test battery is 30, but scores of 21 or higher are considered normal.
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change from baseline to 8 weeks
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Pittsburgh Sleep Quality Index
Time Frame: change from baseline to 8 weeks
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Sleep quality will be evaluated with the Pittsburgh Sleep Quality Index.
The index is a 19-item self-report measure that assesses sleep quality and disturbances over the past month.
The 19 individual items form a score of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping pills, and daytime dysfunction.
Each component is rated on a 0-3 scale.
The sum of the seven components provides the total scale score.
The sum of the seven component scores ranges from 0 to 21; higher scores represent poorer subjective sleep quality.
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change from baseline to 8 weeks
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Modified Fatigue Impact Scale
Time Frame: change from baseline to 8 weeks
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The Modified Fatigue Impact Scale will be used to evaluate the participant's fatigue status in the last month.
The scale consists of 21 questions assessing the physical, cognitive, and social effects of fatigue.
Each item is scored from 0 (no problem) to 4 (maximum problem).
Higher scores indicate increased fatigue exposure, and lower scores indicate a lower degree of fatigue.
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change from baseline to 8 weeks
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Nordic Musculoskeletal Questionnaire
Time Frame: change from baseline to 8 weeks
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The Nordic Musculoskeletal Questionnaire will be used to measure musculoskeletal pain.
This survey consists of three main sections.
The first section addresses any distress (such as pain, aching, discomfort, or numbness) experienced by the participant over the past 12 months.
The second section asks the same question, but it addresses any distress experienced by the participant over the past 7 days.
The final section addresses any injuries caused by distress experienced over the past 12 months.
Data collected in each section relates to different anatomical areas: neck, shoulders, back, elbows, hands/wrists, waist, hips/thighs, knees, and feet/ankles.
The survey primarily inquires about the presence of pain in nine body areas.
Responses are recorded as binary options ("yes" or "no").
If the participant answers "yes," the relevant subquestions are discussed.
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change from baseline to 8 weeks
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Short Form-36
Time Frame: change from baseline to 8 weeks
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Quality of life will be assessed with Short Form-36.
The SF-36 questionnaire measures health status by considering physical functioning and exercise, emotional and physical role functioning, overall mental health, social role functioning, bodily pain, and general health.
The 36 items in the scale give it its name.
This scale consists of eight subscales.
It includes subparameters for pain, physical and social functioning, fatigue, health perception, emotional state, emotional problems, and limitations due to physical problems.
The scale considers the last four weeks.
Questions are scored from 0 to 100.
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change from baseline to 8 weeks
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Behavior
- Personal Satisfaction
- Anxiety Disorders
- Disease
- Panic Disorder
- Psychological Well-Being
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
Other Study ID Numbers
- 9029-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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