Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324214
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-04
Brief Title:
Oral Supplementation During PR Participation in COPD
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Urolithin A Supplementation During Pulmonary Rehabilitation Participation in Patients With Chronic Obstructive Pulmonary Disease a Randomized Pilot and Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic obstructive pulmonary disease COPD is a very common and chronic lung condition and is a leading cause of morbidity and death These patients have persistent breathlessness and exercise intolerance affecting their ability to carry out routine daily tasks Standard COPD treatments include medicinespuffers as well as participation in a Pulmonary Rehabilitation PR program PR programs are delivered by a diverse team of healthcare experts in exercise and nutrition It is possible that an emerging nutritional oral supplement could target the muscular dysfunction seen in patients with COPD in part by promoting better working mitochondria the energy engine of muscle A series of recently published studies in sedentary adults and in older adults have demonstrated the safety tolerability and potential clinical effectiveness of this supplement
In this regard the investigators plan to lead a large randomized controlled trial RCT to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance The investigators will also test muscle strength cognition body composition and other clinically important outcomes such as quality of life Lastly the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on musclemitochondrial structurefunction
The focus is actually the critical first step before the larger RCT a pilot and feasibility study on a smaller number of participants with COPD as an important proof-of-concept that the larger study can and should be conducted
In this regard the investigators plan to lead a large randomized controlled trial RCT to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance The investigators will also test muscle strength cognition body composition and other clinically important outcomes such as quality of life Lastly the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on musclemitochondrial structurefunction
The focus is actually the critical first step before the larger RCT a pilot and feasibility study on a smaller number of participants with COPD as an important proof-of-concept that the larger study can and should be conducted
Detailed Description:
The main objectives for this pilot feasibility study are to document recruitment rates collect information on participant acceptability of tests establish the capacity to run the RCT at our site to demonstrate successful molecular testing of specimens and to generate pilot data for the outcomes being tested in the larger subsequent RCT
The overarching goal for the larger future project will be to determine the effect of the oral supplement on exercise capacity muscle strength mitochondrial function health-related quality of life cognition symptom burden and safetyadherence in patients with COPD who are participating in a Pulmonary Rehabilitation program The goal of the present research project is to complete a pilot and feasibility study testing the same clinical outcomes on a smaller sample of eligible study participants during which participants receive the intervention for 8 weeks
The primary objective is to determine whether administration of the oral supplement during participation in a standard multi-week in-person Pulmonary Rehabilitation PR program is associated with an improvement in exercise endurance capacity in patients with COPD compared with PR participation and placebo supplementation
The secondary objectives are to determine the effect of the oral supplement on i global conditioning and exercise capacity ii muscle strength iii mitochondrial function iv body composition v quality of life and burden of disease vi cognition vii adverse eventscomplications and adherence and viii blood levels of Urolithin A
We hypothesize that patients with COPD receiving oral supplementation during PR participation will demonstrate an improvement in Constant Work Rate Exercise Test CRWET time after 8 weeks when compared to patients with COPD who receive placebo and PR participation
The overarching goal for the larger future project will be to determine the effect of the oral supplement on exercise capacity muscle strength mitochondrial function health-related quality of life cognition symptom burden and safetyadherence in patients with COPD who are participating in a Pulmonary Rehabilitation program The goal of the present research project is to complete a pilot and feasibility study testing the same clinical outcomes on a smaller sample of eligible study participants during which participants receive the intervention for 8 weeks
The primary objective is to determine whether administration of the oral supplement during participation in a standard multi-week in-person Pulmonary Rehabilitation PR program is associated with an improvement in exercise endurance capacity in patients with COPD compared with PR participation and placebo supplementation
The secondary objectives are to determine the effect of the oral supplement on i global conditioning and exercise capacity ii muscle strength iii mitochondrial function iv body composition v quality of life and burden of disease vi cognition vii adverse eventscomplications and adherence and viii blood levels of Urolithin A
We hypothesize that patients with COPD receiving oral supplementation during PR participation will demonstrate an improvement in Constant Work Rate Exercise Test CRWET time after 8 weeks when compared to patients with COPD who receive placebo and PR participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None