Prehabilitation's Effect on Skeletal Muscle Mass in Cardiac Patients

NCT ID: NCT06624774

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2026-09-27

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 participant's 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 patient's 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 1:1 ratio via sealed envelope (https://www.sealedenvelope.com), a secure computerised randomisation programme. Sealed envelope will maintain the allocation sequence concealment, only the participant study number will be entered into the system.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard care

This group will receive NHS standard care. This includes the 'your heart surgery' - a new beginning booklet at the pre-op assessment 2-4 weeks, before surgery as part of routine care. The leaflet will include information regarding heart procedures, recovery, post-surgery rehabilitation, cardiovascular risk factors, lifestyle advice and support

Group Type: NO_INTERVENTION

No interventions assigned to this group

Prehabilitation

Participants randomised to the exercise and education intervention will follow an individualised structured exercise programme and receive group education sessions.

Group Type: ACTIVE_COMPARATOR

Prehabilitation

Intervention Type: OTHER

The structured exercise sessions will be conducted in a homebased setting, consisting of 8 resistance exercises (RE). The 8 RE's will include 4 upper body and 4 lower body exercises (Sit to stand, chest press, heel raises, bicep curls, leg abduction, tricep kickbacks, lunges, mid row). This is adapted from an existing home-based trial in cardiac patients. In addition, the structured exercise programme will include a walking programme. Participants will receive a Fitbit charge 5 activity monitor. Additionally, participants will conduct daily IMT via a Powerbreathe medic plus device. Participants will conduct 6 sets of 6 breaths at 50% of peak inspiratory pressure that has been measured at baseline. Education will be delivered via pre-recorded videos or in person

Interventions

Prehabilitation

The structured exercise sessions will be conducted in a homebased setting, consisting of 8 resistance exercises (RE). The 8 RE's will include 4 upper body and 4 lower body exercises (Sit to stand, chest press, heel raises, bicep curls, leg abduction, tricep kickbacks, lunges, mid row). This is adapted from an existing home-based trial in cardiac patients. In addition, the structured exercise programme will include a walking programme. Participants will receive a Fitbit charge 5 activity monitor. Additionally, participants will conduct daily IMT via a Powerbreathe medic plus device. Participants will conduct 6 sets of 6 breaths at 50% of peak inspiratory pressure that has been measured at baseline. Education will be delivered via pre-recorded videos or in person

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • Between the age of 18-85.

• First time elective cardiac surgery patients who have been deemed clinically stable by the surgical team.
• Able to speak and understand English.
• Medically optimised.
• Absence of contraindications to exercise and exercise testing following the guidance of the Association of Chartered Physiotherapist in Cardiovascular Rehabilitation (ACPICR) and British Association of Cardiovascular Prevention and Rehabilitation (BACPR).

Exclusion Criteria

• • Patients with coexisting congenital heart conditions, significant comorbidities including heart failure (left ventricular ejection fraction (LVEF) <35%), advanced cancer and conditions preventing the patient from providing informed consent.

• Patients with open wounds, ongoing complications and systemic infections
• Contraindications to inspiratory muscle training (Severe asthma exacerbations, recently perforated ear drum, large bullae, history of spontaneous pneumothorax). Following guidance from a recent prehabilitation randomised controlled trial (19).
• Recent thoracic surgery (< 1 year).
• Individuals who do not understand English or have a disability that limits their capacity to understand verbal explanations.
• Those who are currently involved in other research studies.
• Women who are pregnant or breastfeeding.
• Current drug abusers and excessive alcohol drinkers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Manchester Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Stefan Birkett

Chief Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Birkett, PhD

Role: PRINCIPAL_INVESTIGATOR

Manchester Metropolitan University

Locations

Manchester University NHS Foundation Trust, Wythenshawe Hospital

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

56646

Identifier Type: -

Identifier Source: org_study_id