Trial · NCT07910812
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 30 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change in handgrip strength (kg) | Baseline, 3 months, 12 months | Handgrip strength will be assessed using a digital hand dynamometer. Three attempts will be performed with each hand, and the highest value obtained for each hand will be selected. The outcome will be calculated as the mean of the highest left-hand and right-hand values and expressed in kilograms. Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in health-related quality of life assessed by the SF-36 | Baseline, 3 months, 12 months | Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The questionnaire assesses eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes will be assessed from baseline to 3 months and from baseline to 12 months. |
| Secondary | Change in self-reported daily sedentary time (min/day) | Baseline, 3 months, 6 months and 12 months | Self-reported sedentary time will be assessed using the 24-hour Movement Questionnaire (QMov24h). Participants will report the time spent sitting, reclining, or lying down while awake on a typical weekday/workday and weekend/non-workday. Responses will be converted to minutes per 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 self-reported daily light-intensity physical activity (min/day) | Baseline, 3 months, 6 months, 12 months. | Self-reported light-intensity physical activity will be assessed using the 24-hour Movement Questionnaire (QMov24h). Participants will report their daily time spent in light-intensity aerobic and muscle-strengthening activities during a typical week, distinguishing weekday/workdays from weekend/non-workdays. Times will be converted to minutes and summed to obtain total light-intensity physical activity. Mean daily time will be calculated by weighting each day type by its frequency in the week. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Change in self-reported daily moderate-to-vigorous physical activity (min/day) | Baseline, 3 months, 6 months, 12 months. | Self-reported moderate-to-vigorous physical activity will be assessed using the 24-hour Movement Questionnaire (QMov24h). Participants will report time spent in moderate- and vigorous-intensity aerobic and muscle-strengthening activities for each day of a typical week. Times will be converted to minutes and summed across activity types, intensities, and all seven days. The weekly total will be divided by seven to obtain mean daily moderate-to-vigorous physical activity, expressed in minutes/day. The main comparison will be change from baseline to 6 months, with additional comparisons from baseline to 3 and 12 months. |
| Secondary | Attendance at behavioural counselling sessions (%) | During the intervention period (0-6 months). | Attendance at behavioural counselling sessions will be assessed in participants allocated to the intervention group. For each participant, attendance will be calculated as the number of counselling sessions attended divided by the number of counselling sessions scheduled during the 6-month intervention period, multiplied by 100. Attendance will be documented in study records. |
| Secondary | Attendance at supervised cardiac rehabilitation exercise sessions (%) | During the 12-month study period (0-12 months). | Attendance at supervised cardiac rehabilitation exercise sessions will be assessed in both study groups. For each participant, attendance will be calculated as the number of exercise sessions attended divided by the number of scheduled exercise sessions during the 12-month study period, multiplied by 100. Attendance will be obtained from the cardiac rehabilitation programme's attendance records. |
| Secondary | Delivery of scheduled digital prompts (%) | During the intervention period (0-6 months). | Delivery of digital prompts will be assessed in participants allocated to the intervention group. For each participant, the delivery percentage will be calculated as the number of digital prompts sent divided by the number of digital prompts scheduled during the 6-month intervention period, multiplied by 100. Sending of prompts will be documented in study records. This measure assesses intervention delivery rather than whether participants read or acted on the prompts. |
| Other | Change in activPAL-estimated time in bed (hours/night; exploratory) | Baseline, 3, 6, and 12 months. | Time in bed will be estimated using 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 to identify the main nightly time-in-bed period. Algorithm-defined periods will be visually reviewed. A valid night will require a complete recording covering this period, without device removal or data loss preventing identification of its start and end. At least 4 valid nights, including at least 1 weekend night, will be required. The outcome will be the mean estimated time in bed across valid nights, expressed in hours/night. This measure represents estimated time in bed rather than actual sleep duration. Changes will be assessed from baseline to 3, 6, and 12 months. |
| Other | Discrepancy between self-reported and device-measured sedentary time (min/day; exploratory) | Baseline, 3 months, 6 months, and 12 months | Discrepancy in daily sedentary time will be calculated as self-reported sedentary time assessed using the QMov24h questionnaire minus sedentary time estimated using activPAL4 micro, both expressed in minutes/day. Negative values indicate lower self-reported estimates than device-measured estimates, whereas positive values indicate higher self-reported estimates. Differences will be calculated at each assessment, and changes from baseline to 3, 6, and 12 months will be explored. Interpretation will account for the different reference periods: a typical week for the questionnaire and the monitored days for activPAL. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07910812/registered?page=2