Clinical trial NCT06624774: Prehabilitation's Effect on Skeletal Muscle Mass in Cardiac Patients
Official title: The Effect of Prehabilitation on Appendicular Skeletal Muscle Mass in Cardiac Patients Awaiting First Time Elective Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: prehabilitation
homebased
CABG
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2024-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomised clinical trial with two groups
Primary purpose: TREATMENT

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.

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) \&amp;lt;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 (\&amp;lt; 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

Primary outcomes:
measure: The primary outcome of this study will be the change in appendicular skeletal muscle mass (KG/M2).
timeFrame: Baseline, 12 weeks and one week prior to surgery
Secondary outcomes:
measure: Pre-operative preparedness for surgery
timeFrame: recorded one-week pre operation
measure: Handgrip strength
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Physical Performance
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Aerobic capacity
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Health related Quality of Life
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Inspiratory muscle function
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Anxiety and depression
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Nutrition
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Adherence
timeFrame: Baseline, 12 weeks and one week prior to surgery
measure: Blood Pressure
timeFrame: Baseline, 12 weeks and one week prior to surgery
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust, Wythenshawe Hospital
Study officials:
affiliation: Manchester Metropolitan University
name: Stefan Birkett, PhD
role: PRINCIPAL_INVESTIGATOR
References: