Prehabilitation's Effect on Skeletal Muscle Mass in Cardiac Patients

NCT06624774 | Active Not Recruiting

• 1 other identifier: 56646
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the effect prehabilitation on skeletal muscle mass via a scanner.

Conditions

Cardiovascular Diseases

Keywords

prehabilitation; homebased; CABG

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be the change in appendicular skeletal muscle mass (KG/M2).

  Appendicular skeletal muscle mass will be measured via DEXA scan

  Baseline, 12 weeks and one week prior to surgery

Secondary Outcomes (10)

• Pre-operative preparedness for surgery

  recorded one-week pre operation

• Handgrip strength

  Baseline, 12 weeks and one week prior to surgery

• Physical Performance

  Baseline, 12 weeks and one week prior to surgery

• Aerobic capacity

  Baseline, 12 weeks and one week prior to surgery

• Health related Quality of Life

  Baseline, 12 weeks and one week prior to surgery

Study Arms (2)

Standard care

NO INTERVENTION

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

Prehabilitation

ACTIVE COMPARATOR

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

Other: Prehabilitation

Interventions

Prehabilitation 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

Prehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester Metropolitan University: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust, Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Stefan Birkett, PhD

  Manchester Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be partially blinded. The participants in both groups will be blinded from the goal of the measurements taking place. For example, the participants will not be informed specific goal of change of appendicular skeletal muscle mass. The reason for this is, if the participant knows the exact aims of the study, there would be an increased risk of the participants implementing unnatural daily habits, potentially skewing the results. The study cannot be fully blinded due to the exercise and education intervention taking place
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Model Details: Pilot randomised clinical trial with two groups

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 3, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)