Trial · NCT06324214
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Feasibility Outcome: Recruitment rate | From study launch to study completion at every visit until post-intervention visit (average week 14) | The proportion of participants who agree to participate out of the number of all potential participants asked to participate. Recruitment rate represents the primary feasibility outcome of the current pilot RCT. |
| Primary | Constant Work Rate Exercise Test (CWRET) | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Exercise test whereby the workload is constant and is calculated as a percentage of the peak power output observed in the incremental test. CWRET time represents the pre-specified primary outcome of the planned main RCT. |
| Secondary | Feasibility Outcome: Attrition rate | From study launch to study completion at every visit until post-intervention visit (average week 14) | The percentage of participants who do not complete the study out of all participants randomized. Outcome of the current pilot RCT. |
| Secondary | Adherence/Fidelity Outcome: Differences in dosed missed | 8 weeks | The total number of doses missed will be recorded and reported. Outcome of the current pilot RCT. |
| Secondary | Feasibility Outcome: Study test completion rate | From study launch to study completion at every visit until post-intervention visit (average week 14) | Study test completion rate of each assessment (percentage of participants who complete each assessment). Outcome of the current pilot RCT. |
| Secondary | Safety Outcome: Adverse events | 14 weeks | Adverse events (AEs) will be monitored from the signing of the Informed Consent Form (ICF) through completion of study participation. If any AEs do occur, study participants will be followed until symptoms have resolved or have returned to baseline levels. All outstanding AEs will be followed until resolution or until the participant's last study visit. |
| Secondary | 6-Minute Walk Test (6MWT) | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | 6-Minute Walk Distance (6MWD) obtained on a standard 6MWT. |
| Secondary | Quadriceps strength | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | 4-second maximum quadriceps strength test. |
| Secondary | Disease-specific impact on quality of life | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | St. George's respiratory questionnaire (SGRQ) score is a patient reported outcome measuring quality of life from 0-100 where higher scores indicate worse quality of life. |
| Secondary | Burden of disease | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | COPD assessment test (CAT) scores is a patient reported outcome measuring COPD symptom burden from 0-40 where higher scores indicate worse symptom burden. |
| Secondary | Body composition | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Dual X-ray absorptiometry (DXA) scan |
| Secondary | Body impedance | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Bioelectrical impedance assay (BIA) |
| Secondary | Isokinetic cycling peak power output (PPO) | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Isokinetic cycling PPO is measured during a ≤10-second cycling effort on a stationary isokinetic bicycle. |
| Secondary | Cognition | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Stroop test |
| Secondary | Adherence/Fidelity Outcome: Blood levels of the intervention | Day 28 | Blood levels of Urolithin A will be collected at the mid-point of the study. |
| Secondary | Feasibility Outcome: Muscle biopsy volunteer rate | From study launch to study completion at every visit until post-intervention visit (average week 14) | Proportion of participants who consent to the optional muscle biopsy out of those who also meet eligibility criteria for the optional muscle biopsy. |
| Other | Exploratory Outcome: Mitochondrial function | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Fresh samples |
| Other | Exploratory Outcome: Muscle histology | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Stains for mitochondrial markers (including succinate dehydrogenase (SDH)): post-intervention in comparison to pre-intervention. |
| Other | Exploratory Outcome: Specific protein detection | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Targeted Western blot analysis for proteins related to mitochondrial function: post-intervention in comparison to pre-intervention. |
| Other | Exploratory Outcome: Tissue microscopy | Pre-intervention (baseline) and Post-intervention (after 8 weeks) | Transmission electron microscopy for assessment of morphology of mitochondria: post-intervention in comparison to pre-intervention. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06324214/registered