Trial · NCT07910812
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in daily sedentary time (h/day) | Baseline, 3 months, 6 months, 12 months | Daily sedentary time will be measured using activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days per assessment under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm to identify time in bed and non-wear periods. Sedentary time will be calculated as time classified as sitting/lying during waking wear time, expressed in hours/day. A valid day will require at least 10 hours of waking wear time. At least 4 valid days, including at least 1 weekend day, will be required. The outcome will be the mean daily sedentary time across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in sedentary time (% of waking time) | Baseline, 3 months, 6 months, 12 months. | Sedentary time as a percentage of waking wear time will be measured using activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days per assessment under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm to identify time in bed and non-wear periods. For each valid day, sedentary time (%) will be calculated as minutes classified as sitting/lying during waking wear time divided by total minutes of waking wear time, multiplied by 100. A valid day will require at least 10 hours of waking wear time. At least 4 valid days, including at least 1 weekend day, will be required. The outcome will be the mean of the daily percentages across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in daily number of breaks in sedentary time (breaks/day) | Baseline, 3 months, 6 months, 12 months. | The daily number of breaks in sedentary time will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A break will be defined as a transition from sitting/lying to standing or stepping during waking wear time. A valid day will require at least 10 hours of waking wear time. At least 4 valid days, including at least 1 weekend day, will be required. The outcome will be the mean daily number of breaks across valid days, expressed as breaks/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in daily number of sedentary bouts (bouts/day) | Baseline, 3 months, 6 months, 12 months. | The daily number of sedentary bouts will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. The outcome will be the mean number of sedentary bouts per day across valid days, expressed as bouts/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months |
| Secondary | Change in median sedentary bout duration (min) | Baseline, 3 months, 6 months, 12 months. | Median sedentary bout duration will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, the median duration of sedentary bouts will be calculated in minutes. The outcome will be the mean of these daily medians across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in mean sedentary bout duration (min) | Baseline, 3 months, 6 months, 12 months. | Mean sedentary bout duration will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, mean sedentary bout duration will be calculated by dividing total sedentary time by the number of sedentary bouts, expressed in minutes. The outcome will be the average of these daily means across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in maximum sedentary bout duration (min) | Baseline, 3 months, 6 months, 12 months. | Maximum sedentary bout duration will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, the duration of the longest sedentary bout will be identified in minutes. The outcome will be the mean of these daily maximum durations across valid days. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in daily time accumulated in sedentary bouts lasting ≥30 minutes (min/day) | Baseline, 3 months, 6 months, 12 months. | Daily time accumulated in sedentary bouts lasting at least 30 minutes will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking time. For each valid day, the full duration of all sedentary bouts lasting at least 30 minutes will be summed. The outcome will be the mean of these daily totals across valid days, expressed as minutes/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in daily time accumulated in sedentary bouts lasting ≥60 minutes (min/day) | Baseline, 3 months, 6 months, 12 months. | Daily time accumulated in sedentary bouts lasting at least 60 minutes will be derived from activPAL4 micro (PAL Technologies), worn on the anterior-medial thigh for 7 consecutive days under a 24-hour wear protocol. Data will be processed using PALanalysis with the CREA algorithm. A sedentary bout will be defined as a continuous period classified as sitting/lying during waking wear time. For each valid day, the full duration of all sedentary bouts lasting at least 60 minutes will be summed. The outcome will be the mean of these daily totals across valid days, expressed as minutes/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in daily light-intensity physical activity (min/day) | Baseline, 3 months, 6 months, and 12 months | Light-intensity physical activity will be assessed using an ActiGraph wGT3X-BT worn on the non-dominant wrist for 7 consecutive days under a 24-hour wear protocol. Raw signals will be processed using GGIR in R to derive Euclidean Norm Minus One (ENMO). Light-intensity physical activity will be defined as time with ENMO values from 45 to less than 100 mg. The outcome will be the mean daily time spent in light-intensity physical activity across valid days, expressed in minutes/day. A valid day will require at least 10 hours of waking wear time. At least 4 valid days, including at least 1 weekend day, will be required. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in daily moderate-to-vigorous physical activity (min/day) | Baseline, 3 months, 6 months, 12 months. | Moderate-to-vigorous physical activity (MVPA) will be assessed using an ActiGraph wGT3X-BT worn on the non-dominant wrist for 7 consecutive days under a 24-hour wear protocol. Raw signals will be processed using GGIR in R to derive Euclidean Norm Minus One (ENMO). MVPA will be defined as time with ENMO values of at least 100 mg. The outcome will be the mean daily time spent in MVPA across valid days, expressed in minutes/day. A valid day will require at least 10 hours of waking wear time. At least 4 valid days, including at least 1 weekend day, will be required. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in steps per day (count/day) | Baseline, 3 months, 6 months, and 12 months. | PA will be assessed with an ActiGraph wGT3X-BT worn on the non-dominant wrist for 7 consecutive days under a 24-h wear protocol. Steps per day will be obtained from the device's step algorithm and averaged across valid days. A valid day requires ≥10 h of waking wear time; a valid week requires ≥4 valid days (including ≥1 weekend day). The main comparison is change from baseline to 6 months; additional time points at 3 and 12 months. |
| Secondary | Change in total body fat mass (kg) | Baseline, 3 months, 12 months | Total body fat mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and expressed in kilograms. Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in total body fat percentage (%) | Baseline, 3 months, 12 months | Total body fat percentage will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and expressed as the percentage of total body mass that is fat mass. Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in total body lean mass (kg) | Baseline, 3 months, 12 months | Total body lean mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and expressed in kilograms. Lean mass refers to lean soft tissue, excluding fat mass and bone mineral content. Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in appendicular lean mass (kg) | Baseline, 3 months, 12 months. | Appendicular lean mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA) and calculated as the sum of lean soft tissue mass in both arms and both legs, excluding bone mineral content. The outcome will be expressed in kilograms. Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in estimated visceral adipose tissue mass (g) | Baseline, 3 months, 12 months. | Visceral adipose tissue mass will be estimated from whole-body dual-energy X-ray absorptiometry (DXA) scans using the Hologic system's visceral fat analysis software. The software estimates visceral adipose tissue within an abdominal region of interest by subtracting estimated subcutaneous fat from total fat in that region. The outcome will be expressed in grams. Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in whole-body bone mineral density (g/cm²) | Baseline, 3 months, 12 months. | Whole-body areal bone mineral density will be assessed using dual-energy X-ray absorptiometry (DXA) and expressed in grams per square centimetre (g/cm²). Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in peak oxygen uptake (VO₂peak; mL/kg/min) | Baseline, 3 months, 12 months | Peak oxygen uptake (VO₂peak) will be assessed using a symptom-limited incremental cardiopulmonary exercise test (CPET) performed on a cycle ergometer with breath-by-breath gas analysis. VO₂peak will be defined as the highest 30-second average oxygen uptake recorded during the final minute of exercise and expressed in millilitres of oxygen per kilogram of body mass per minute (mL/kg/min). Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in peak workload (W) | Baseline, 3 months, 12 months. | Peak workload will be assessed using a symptom-limited incremental cardiopulmonary exercise test (CPET) performed on a cycle ergometer. Peak workload will be defined as the highest work rate reached during the exercise phase and expressed in watts (W). Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
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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