Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624774
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Prehabilitations Effect on Skeletal Muscle Mass in Cardiac Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Prehabilitation on Appendicular Skeletal Muscle Mass in Cardiac Patients Awaiting First Time Elective Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will investigate the effect prehabilitation on skeletal muscle mass via a scanner
Detailed Description:
Post COVID 19 data demonstrates vast increases regarding wait times for elective cardiac procedures 104 days Extended wait times will therefore increase sedentary behaviours increasing the risk of patient deterioration pre-operatively Frailty and low muscle mass correlates with poor post-operative outcomes lower physical function and lower quality of life Research regarding prehabilitation in cancer patients demonstrates positive outcomes Additionally early research in cardiac patients shows encouraging findings however there are limited studies regarding prehabilitation in this cohort of patient A recent large public patient involvement PPI study was conducted to address the research needs for cardiac patients carers and medical professionals Research concerning pre-operative interventions and lifestyle advice where key topics ranking in the top three at the conclusion of the study Further emphasising the need for studies focusing on prehabilitation This coupled with no study has assessed the effect of prehabilitation on skeletal muscle provides an important gap in the research to explore
STUDY SETTING This randomised controlled pilot study will take place at the participants home and surrounding areas Data collection will take place at Manchester Metropolitan University
Patient identification Participants who are cleared for elective surgery and who meet the eligibility criteria will be identified by the surgical team at Manchester University NHS Foundation Trust Wythenshawe hospital The investigators will purposively sample individuals from socio-economic deprived areas ethnic minority backgrounds
Consent Once identified the surgical team will provide a brief overview of the study and give the potential participant a participant information sheet PIS If happy a consent to be contacted form will be completed by the potential participant This will be documented in the patients medical notes by the surgical team The surgical team will then scan and transfer the completed consent to be contacted document via dropbox for business and a member of the research team will then contact the patient and answer any questions regarding the PIS and study The potential participants will have 72hrs to decide if they want to take part in the study If the potential participant has not decided after 72hrs they will be able to contact the research team for the next 5 working days if they have decided they want to participate For those who decide to take part written consent will be obtained at their baseline assessment
Withdrawal Criteria Participants will be informed that they are able to withdraw from the study at any time The chief investigator has the right to withdraw the participant from the trial if appropriate for example if the participants circumstances have changed since the start of the study The reasons for withdrawal will be recorded
Randomisation- Method of implementing the allocation sequence Participants will be randomised in a 11 ratio via sealed envelope httpswwwsealedenvelopecom a secure computerised randomisation programme Sealed envelope will maintain the allocation sequence concealment only the participant study number will be entered into the system
STUDY SETTING This randomised controlled pilot study will take place at the participants home and surrounding areas Data collection will take place at Manchester Metropolitan University
Patient identification Participants who are cleared for elective surgery and who meet the eligibility criteria will be identified by the surgical team at Manchester University NHS Foundation Trust Wythenshawe hospital The investigators will purposively sample individuals from socio-economic deprived areas ethnic minority backgrounds
Consent Once identified the surgical team will provide a brief overview of the study and give the potential participant a participant information sheet PIS If happy a consent to be contacted form will be completed by the potential participant This will be documented in the patients medical notes by the surgical team The surgical team will then scan and transfer the completed consent to be contacted document via dropbox for business and a member of the research team will then contact the patient and answer any questions regarding the PIS and study The potential participants will have 72hrs to decide if they want to take part in the study If the potential participant has not decided after 72hrs they will be able to contact the research team for the next 5 working days if they have decided they want to participate For those who decide to take part written consent will be obtained at their baseline assessment
Withdrawal Criteria Participants will be informed that they are able to withdraw from the study at any time The chief investigator has the right to withdraw the participant from the trial if appropriate for example if the participants circumstances have changed since the start of the study The reasons for withdrawal will be recorded
Randomisation- Method of implementing the allocation sequence Participants will be randomised in a 11 ratio via sealed envelope httpswwwsealedenvelopecom a secure computerised randomisation programme Sealed envelope will maintain the allocation sequence concealment only the participant study number will be entered into the system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None