Trial · NCT07893249
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change in Left Ventricular Stroke Volume (LVSV) | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Left ventricular stroke volume (LVSV) will be calculated as the difference between left ventricular end-diastolic and end-systolic volumes obtained using cardiac magnetic resonance (CMR) cine imaging and expressed in milliliters (mL).Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Left ventricular ejection fraction (LVEF) will be calculated as the difference between end-diastolic volume (EDV) and end-systolic volume (ESV), divided by EDV and multiplied by 100. EDV and ESV will be obtained using cardiac magnetic resonance (CMR) cine imaging. LVEF will be expressed as a percentage (%).Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in Left Ventricular Myocardial Mass | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Left ventricular myocardial mass will be quantified using cardiac magnetic resonance (CMR) cine imaging and expressed in grams (g).Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in Left Ventricular Global Longitudinal Strain (GLS) | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Left ventricular global longitudinal strain (GLS) will be assessed using feature-tracking analysis of cardiac magnetic resonance (CMR) cine images and expressed as a percentage (%).Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in Myocardial Native T1 Relaxation Time | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Myocardial native T1 relaxation time will be measured using cardiac magnetic resonance (CMR) T1 mapping sequences and expressed in milliseconds (ms).Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in Myocardial T2 Relaxation Time | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Myocardial T2 relaxation time will be measured using cardiac magnetic resonance (CMR) T2 mapping sequences and expressed in milliseconds (ms).Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in Left Ventricular E/e' Ratio | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | The ratio of early mitral inflow velocity (E) to the average early diastolic mitral annular velocity (e') will be measured using transthoracic echocardiography (TTE) with Doppler imaging and reported as a dimensionless value. Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Adherence to the exercise intervention | From the first exercise session through Week 12 | Number and percentage of prescribed sessions completed and percentage of prescribed exercise energy expenditure achieved. |
| Secondary | Change in body circumferences | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Changes in whole body circumferences will be quantified in centimeters using a three-dimensional body scanner. Changes in each measured circumference will be assessed relative to baseline. |
| Secondary | Change in heart rate and heart rate variability | Baseline, during the 12-week intervention, Week 12, and Week 24 (12 weeks after completion of the intervention). | Changes in heart rate and heart rate variability will be assessed using the prespecified wearable monitoring devices. Resting, exercise, post-exercise, and free-living heart rate will be expressed in beats per minute. Prespecified time-domain and frequency-domain heart rate variability indices will be derived from valid interbeat-interval recordings. Changes at Week 12 and 24 will be assessed relative to baseline. |
| Secondary | Change in total fatigue assessment scale score | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Fatigue will be assessed using the 10-item Fatigue Assessment Scale (FAS). Each item evaluates how frequently the participant usually experiences a fatigue-related symptom and is rated on a 5-point scale: 1 (never), 2 (sometimes), 3 (regularly), 4 (often), and 5 (always). Items 4 and 10 will be reverse-scored. The 10 item scores will be summed to produce a total score ranging from 10 to 50, with higher scores indicating greater fatigue. Changes at Week 12 and Week 24 will be assessed relative to baseline. |
| Secondary | Change in energy rating | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Momentary overall energy will be assessed using Item 1 of the Daytime Energy Data Collection Momentary Energy Questionnaire. Participants will rate their current overall energy level on a 7-point scale ranging from 1 (completely drained) to 7 (peak state). The mean of all valid ratings collected during each assessment period will be calculated. Higher scores indicate a higher perceived energy level. Changes at Week 12 and Week 24 will be assessed relative to baseline. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Changes in the global score and prespecified component scores will be assessed relative to baseline. |
| Secondary | Change in average nightly sleep efficiency measured by actigraphy | Fourteen-day monitoring periods at baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Sleep will be monitored using an ActiGraph GT3XP-BTLE triaxial accelerometer. Sleep efficiency will be calculated as total sleep time divided by time in bed and multiplied by 100. The average sleep efficiency across all valid monitoring nights during each assessment period will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline. |
| Secondary | Change in average sleep efficiency measured using the ISHO ring | Throughout from baseline to Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention). | Sleep will be monitored using the ISHO ring. Sleep efficiency will be calculated using the device-specific algorithm as total sleep time divided by time in bed and multiplied by 100. The average sleep efficiency across all valid monitoring nights during each assessment period will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline. |
| Secondary | Change in MRI-derived slow-twitch muscle fiber proportion in the soleus | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | The proportion of slow-twitch muscle fibers in the soleus will be estimated using the prespecified magnetic resonance imaging. The slow-twitch muscle fiber proportion will be expressed as a percentage of the assessed soleus muscle tissue. Changes at Week 12 and Week 24 will be assessed relative to baseline. |
| Secondary | Change in MRI-derived slow-twitch muscle fiber proportion in the gastrocnemius | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | The proportion of slow-twitch muscle fibers in the gastrocnemius will be estimated using the prespecified magnetic resonance imaging. The slow-twitch muscle fiber proportion will be expressed as a percentage of the assessed gastrocnemius muscle tissue. Changes at Week 12 and Week 24 will be assessed relative to baseline. |
| Secondary | Change in mean core body temperature | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Core body temperature will be continuously measured using an ingestible e-Celsius temperature capsule (BodyCap). Recording will begin after the capsule reaches the gastrointestinal tract. The mean of all valid temperature readings collected during each monitoring period will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C). |
| Secondary | Change in mean tympanic temperature | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Tympanic temperature will be continuously measured using a VitThermo (SKINOS, VTB-01) temperature monitor. The mean of all valid temperature readings collected during each monitoring period will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C). |
| Secondary | Change in mean ambient temperature exposure | Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention). | Ambient temperature exposure will be measured using an iButton (DS1921G). The device will record the temperature of the participant's surrounding environment during each monitoring period. The mean of all valid temperature readings will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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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