Trial · NCT07913503
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Anxiety Severity Measured by the GAD-7 | Baseline (week 1) and at the end of the intervention (week 8). | Anxiety severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire assessing anxiety symptoms over the previous two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. The change in total score from baseline to the end of the intervention will be evaluated. |
| Secondary | Change in Forced Vital Capacity (FVC) | Baseline (week 1) and at the end of the intervention (week 8). | Pulmonary function will be assessed using spirometry. Forced vital capacity (FVC), representing the maximum volume of air that can be forcibly exhaled after a full inspiration, will be measured in liters (L). |
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | Baseline (week 1) and at the end of the intervention (week 8). | Pulmonary function will be assessed using spirometry. Forced expiratory volume in one second (FEV1), representing the volume of air forcibly exhaled during the first second, will be measured in liters (L). |
| Secondary | Change in FEV1/FVC Ratio | Baseline (week 1) and at the end of the intervention (week 8). | The FEV1/FVC ratio will be calculated by dividing forced expiratory volume in one second (FEV1) by forced vital capacity (FVC) and will be expressed as a percentage (%). |
| Secondary | Change in Peak Expiratory Flow (PEF) | Baseline (week 1) and at the end of the intervention (week 8). | Peak expiratory flow (PEF) will be assessed using spirometry and expressed in liters per second (L/s). |
| Secondary | Change in Respiratory Muscle Strength | Baseline (week 1) and at the end of the intervention (week 8). | Respiratory muscle strength will be assessed by measuring maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). |
| Secondary | Change in Functional Exercise Capacity | Baseline (week 1) and at the end of the intervention (week 8). | Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). The total distance walked will be recorded in meters. |
| Secondary | Change in Sleep Quality | Baseline (week 1) and at the end of the intervention (week 8). | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
| Secondary | Change in Health-Related Quality of Life | Baseline (week 1) and at the end of the intervention (week 8). | Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates eight health dimensions. Scores range from 0 to 100, with higher scores indicating better health status. |
| Secondary | Change in Perceived Dyspnea | Baseline (week 1) and at the end of the intervention (week 8), during or immediately after the relevant activity or test. | Perceived dyspnea will be assessed using the Modified Borg Dyspnea Scale, which ranges from 0 (no breathlessness) to 10 (maximum breathlessness). |
| Secondary | Change in Anxiety Symptoms Measured by the Beck Anxiety Inventory | Baseline (week 1) and at the end of the intervention (week 8). | Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms. |
| Secondary | Change in Depressive Symptoms | Baseline (week 1) and at the end of the intervention (week 8). | Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. |
| Secondary | Change in Heart Rate Variability (RMSSD) | Baseline (week 1) and at the end of the intervention (week 8). | Heart rate variability will be assessed using the root mean square of successive differences (RMSSD) derived from R-R intervals recorded with a Polar H10 heart rate sensor. Recordings will be obtained during a 5-minute resting period under standardized conditions and analyzed using Kubios HRV Standard software. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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