Cardiovascular DiseasesNCT06624774
Prehabilitation's Effect on Skeletal Muscle Mass in Cardiac Patients
A study testing Prehabilitation in people with Cardiovascular Diseases, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
The study will investigate the effect prehabilitation on skeletal muscle mass via a scanner. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2024to 27 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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).
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust, Wythenshawe Hospital
Manchester, M23 9LT
About this study
Official title: The Effect of Prehabilitation on Appendicular Skeletal Muscle Mass in Cardiac Patients Awaiting First Time Elective Surgery
The study will investigate the effect prehabilitation on skeletal muscle mass via a scanner.
Read the 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
- Being tested
- Prehabilitation
- Keywords
- prehabilitation, homebased, CABG
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 weeks and one week prior to surgery
Secondary outcomes (10)
Pre-operative preparedness for surgery
Participants will conduct a pre-operative preparedness for surgery questionnaire adapted from Kenton, Pham (32). The questionnaire will consist of 10 questions, regarding the surgical procedure and surgical aftermath
Measured: recorded one-week pre operation
Handgrip strength
Hand grip assessment will be performed by hand dynamometer (JAMAR plus) and the method used will be the Southampton protocol. Participants will squeeze the hand dynamometer for 5 seconds. This will be performed three times by each arm with the highest score being recorded
Measured: Baseline, 12 weeks and one week prior to surgery
Physical Performance
The SPPB will is a validated method to assess physical function (25). The test will consist of three timed tasks that assess the patients gait speed, standing balance and chair sit to stand. Individual scores are given for each test based on the defined cut-off points. The score then be calculated with 0 being the lowest score and 12 being the highest
Measured: Baseline, 12 weeks and one week prior to surgery
Aerobic capacity
Via a six minute walk self paced test
Measured: Baseline, 12 weeks and one week prior to surgery
Health related Quality of Life
Quality of life will be obtained via a 5-component scale questionnaire (EQ-5D-5L). The questionnaire will measure mobility, self-care, usual activities, pain/discomfort and anxiety and depression. Additionally, the questionnaire will include a 20cm analogue scale labelled from 0-100 aimed to assess patient health on the day, 100 will corelate with the best health possible and 0 will align with the worst
Measured: Baseline, 12 weeks and one week prior to surgery
Inspiratory muscle function
Maximal inspiratory pressure will be conducted to assess inspiratory muscle strength utilising a handheld respiratory pressure meter. The same pressure gauge will be used for all testing and calibrated to certify accuracy. Each participant will perform the manoeuvre 5 times, the aim is to have the two highest values within 10cmH20
Measured: Baseline, 12 weeks and one week prior to surgery
Anxiety and depression
Anxiety and depression will be measured via the Hospital anxiety and depression questionnaire (HADS). The questionnaire will be presented in the form of a 0-3 Likert scale. Participants will have a total of 14 questions to answer, 7 anxiety questions and 7 depression questions
Measured: Baseline, 12 weeks and one week prior to surgery
Nutrition
Participants will conduct a 5-day food diary via the digital application Libro. This will allow for the measurements of total calories (Kcals), protein intake, fat intake and carbohydrate intake
Measured: Baseline, 12 weeks and one week prior to surgery
Adherence
Adherence will be assessed by monitoring participant logbook entries to account for participant adherence to exercise protocol, during the study. Entries will include, completed exercise sessions and partially completed sessions. Drop-out from the programme will also be documented for both study groups in addition to the reasons for drop-out, where provided by the participants
Measured: Baseline, 12 weeks and one week prior to surgery
Blood Pressure
Blood pressure will be measured via the Omron blood pressure monitor (Omron Healthcare, Milton Keynes, United Kingdom).
Measured: Baseline, 12 weeks and one week prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start23 Sep 2024
- Primary completion27 Sep 2026 (estimated)
- Study completion27 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomised clinical trial with two groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Stefan Birkett, Manchester Metropolitan University
- Investigators
- Stefan Birkett, PhD, Principal investigator, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624774
- Sponsor's protocol ID
- 56646
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers outside of this project.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prehabilitation on Appendicular Skeletal Muscle Mass in Cardiac Patients Awaiting First Time Elective Surgery
- ClinicalTrials.gov ID
- NCT06624774
- Acronym / sponsor ID
- 56646
- Conditions
- Cardiovascular Diseases
- Keywords
- prehabilitation, homebased, CABG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 27 Sep 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomised clinical trial with two groups
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: PrehabilitationParticipants randomised to the exercise and education intervention will follow an individualised structured exercise programme and receive group education sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Between the age of 18-85.
Key exclusion criteria (8 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationThe 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 | Other | Prehabilitation |
Primary outcome
The primary outcome of this study will be the change in appendicular skeletal muscle mass (KG/M2).
Time frame: Baseline, 12 weeks and one week prior to surgery
Appendicular skeletal muscle mass will be measured via DEXA scan
10 secondary outcomes
Pre-operative preparedness for surgery
Time frame: recorded one-week pre operation
Handgrip strength
Time frame: Baseline, 12 weeks and one week prior to surgery
Physical Performance
Time frame: Baseline, 12 weeks and one week prior to surgery
Aerobic capacity
Time frame: Baseline, 12 weeks and one week prior to surgery
Health related Quality of Life
Time frame: Baseline, 12 weeks and one week prior to surgery
Inspiratory muscle function
Time frame: Baseline, 12 weeks and one week prior to surgery
Anxiety and depression
Time frame: Baseline, 12 weeks and one week prior to surgery
Nutrition
Time frame: Baseline, 12 weeks and one week prior to surgery
Adherence
Time frame: Baseline, 12 weeks and one week prior to surgery
Blood Pressure
Time frame: Baseline, 12 weeks and one week prior to surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers outside of this project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Birkett, PhD principal investigator
Manchester Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Cardiovascular Diseases, run by Manchester Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this study will be the change in appendicular skeletal muscle mass (KG/M2). (time frame: Baseline, 12 weeks and one week prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.