Trial · NCT07884968
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment Rate | During the recruitment period | Proportion of eligible women who agreed to participate and were enrolled and randomised in the study, expressed as a percentage of all eligible women invited to participate. |
| Primary | Screening-to-Randomisation Yield | During the recruitment period | Description Proportion of women randomised into the study relative to the total number of women assessed for eligibility, expressed as a percentage. |
| Primary | Retention Rate | From randomisation to the final follow-up assessment (six months after radiotherapy). | Proportion of randomised participants who completed all study assessments, expressed as a percentage of the total number of randomised participants. |
| Primary | Attendance at Face-to-Face Physiotherapy Sessions | Throughout the four-week intervention period. | Proportion of individual face-to-face physiotherapy sessions attended relative to the total number of scheduled sessions, expressed as a percentage. |
| Primary | Adherence to the Home-Based Exercise Programme | Throughout the four-week intervention period. | Proportion of intervention weeks during which participants achieved the prescribed exercise target of at least 30 minutes per day, five days per week, expressed as a percentage. |
| Primary | Adherence to Respiratory Training | Throughout the four-week intervention period. | Proportion of intervention weeks during which participants in the experimental group achieved the prescribed respiratory training target of at least 30 minutes per day, five days per week, expressed as a percentage. |
| Primary | Adverse Events Related to the Intervention (Safety) | Throughout the four-week intervention period | Number and proportion of participants experiencing adverse events during the intervention period. Adverse events were recorded and classified according to their type, seriousness, and potential relationship to the study intervention. |
| Secondary | Forced Expiratory Volume in One Second (FEV1) | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | Forced expiratory volume in one second (FEV1) was assessed using spirometry and expressed as a percentage of the predicted value (% predicted). |
| Secondary | Forced Vital Capacity (FVC) | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | Forced vital capacity (FVC) was assessed using spirometry and expressed as a percentage of the predicted value (% predicted). |
| Secondary | Diffusing Capacity of the Lung for Carbon Monoxide (DLCOadj) | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | Lung diffusing capacity for carbon monoxide (DLCO), adjusted for haemoglobin concentration, was assessed using the single-breath diffusion test and expressed as a percentage of the predicted value (% predicted). |
| Secondary | Alveolar Volume (VA) | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | Alveolar volume (VA) was assessed during the single-breath lung diffusion test and expressed as a percentage of the predicted value (% predicted). |
| Secondary | Carbon Monoxide Transfer Coefficient (KCO) | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | Carbon monoxide transfer coefficient (KCO) was assessed using the single-breath lung diffusion test and expressed as a percentage of the predicted value (% predicted). |
| Secondary | One-Minute Sit-to-Stand Test (1minSTS) | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | Functional capacity was assessed using the one-minute sit-to-stand test (1minSTS). The total number of complete sit-to-stand repetitions performed within one minute was recorded. |
| Secondary | Six-Minute Walking Distance (6MWD) | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | Functional capacity was assessed using the six-minute walk test (6MWT). The total distance walked in six minutes was recorded in metres. |
| Secondary | Self-reported physical activity and sedentary time | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | It was were assessed using the International Physical Activity Questionnaire-short form-IPAQ-sf and expressed as metabolic equivalent minutes per week (MET-min/week). |
| Secondary | Fatigue | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | It was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-FS). The scale consists of 13 items, with a total score ranging from 0 to 52. Higher scores indicate lower levels of fatigue and better outcomes. |
| Secondary | Health-Related Quality of Life | Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2 | It was assessed using the Functional Assessment of Cancer Therapy-Breast questionnaire. (FACT-B). The questionnaire consists of 37 items, with a total score ranging from 0 to 148. Higher scores indicate better health-related quality of life. |
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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