Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527742
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Body Composition Frailty and Function in Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Correlations of Body Composition Measures With Functional Outcomes and the Clinical Frailty Scale in Inpatient Rehabilitation A Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 investigators are investigating if body composition measures - in particular muscle mass body fat and something called the phase angle - are able to reliably predict functional outcomes for patients who are in an acute hospital for inpatient rehabilitation The investigators also want to see if age and frailty affect these relationships
Patients undergoing inpatient rehabilitation in our hospital will be monitored through a variety of frailty-specific tools including strength and speed The investigators will use a device called a body composition monitor BCM to record their body composition measurements These will then be compared against their usual rehabilitation outcomes
The investigators believe that there is a correlation between these measures and a patients functional outcomes
Patients undergoing inpatient rehabilitation in our hospital will be monitored through a variety of frailty-specific tools including strength and speed The investigators will use a device called a body composition monitor BCM to record their body composition measurements These will then be compared against their usual rehabilitation outcomes
The investigators believe that there is a correlation between these measures and a patients functional outcomes
Detailed Description:
STUDY DESIGN This study is conceived as a prospective longitudinal follow-up cohort study tracking patients from admission to the inpatient rehabilitation unit till discharge Ethics approval has been obtained Trial registration will be performed Reporting will conform to the STROBE guidelines
STUDY POPULATION Consecutive purposive sample of all patients with stroke deconditioning lung disease or amputation admitted to the CGH Rehabilitation Medicine unit
CONDUCT OF STUDY The study will take place in the main inpatient ward of the CGH Rehabilitation Medicine unit All patients transferred in for inpatient rehabilitation will undergo case note screening and physical examination as part of their routine post-transfer clerking Patients fulfilling the inclusion and exclusion criteria will be approached for recruitment and enrolment within 48 work hours of transfer in to the unit Baseline measurements will be collected and they will undergo usual rehabilitation with the hospitals multidisciplinary team Repeat measurements will also be collected upon discharge
DATA COLLECTION
Patient data will be collected upon consent including
1 Demographic data
1 Age ethnicity and gender
2 Handedness
3 Occupation and employment status
4 Highest education level
5 Living arrangements and housing type
2 Anthropometric data
1 Height and body mass index BMI
2 BIA measures of appendicular skeletal mass ASM phase angle PhA and percentage body fat PBF - measured twice and at least 15mins apart
3 Functional data
1 Premorbid mobility
2 Activities of daily living by the Katz Index
3 Functional Independence Measure FIM
4 Clinical data
1 Diagnosis group
2 Charlson Comorbidity Index
3 Intrinsic capacity measures per the Integrated Care for Older People screening guidance ICOPE
4 Sarcopenia measured by the SARC-CalF tool
5 Frailty measured by CFS and the FRAIL questionnaire
6 Cognition by the Chinese version 28 marks of the Mini-Mental State Examination MMSE
7 Mood by the Hospital Anxiety and Depression Scale HADS
8 Nutrition by the Mini Nutritional Assessment Short-Form MNA-SF
9 Quality of Life by the 5-item EuroQOL 5-dimension questionnaire EQ-5D-5L
10 Handgrip strength - measured twice
11 Average medial gastrocnemius thickness by ultrasonography
12 Routine blood test results if done prior of white cell count C-reactive protein albumin iron saturation and Vitamin D
5 Physical performance data
1 10-metre walk test
2 5-times sit-to-stand test
On discharge the following will be collected
1 Anthropometric data
1 Updated body mass index BMI
2 BIA measures of ASM PhA and PBF
2 Clinical data
1 Mood by the Hospital Anxiety and Depression Scale HADS
2 Quality of Life by the 5-item EuroQOL 5-dimension questionnaire EQ-5D-5L
3 Handgrip strength
3 Physical performance data
1 10-metre walk test
2 5-times sit-to-stand test
4 Administrative data a Length of stay by total duration and segmental stays in the acute and rehabilitation settings respectively b Confounders that could have affected rehabilitation adherence or participation occurrence during stay of i Acute transient or irreversible cognitive dysfunction ii Mood dysfunction iii Moderatesevere pain and iv Low patient self-efficacy All tools and questionnaires used are validated and included in many clinical guidelines both local and international
SUBGROUP ANALYSIS
The investigators will perform subgroup analysis along 3 phenotypes
1 Admitting diagnosis group strokes deconditioning pulmonary and lower limb amputee
2 Frailty status frail at-risk and non-frail patients as defined by CFS scores of 5 4 and 3 respectively
3 Age 60yrs and 60yrs
STATISTICAL AND ANALYTICAL PLANS Descriptive statistics of patient demographic and clinical characteristics will be reported as number and percent for categorical data mean SD for normally distributed data and median and interquartile range IQR for non-normally distributed data Intergroup comparisons will be made using the χ²Fishers exact test for categorical outcomes unpaired t-test for normally distributed outcomes and Mann-Whitney U-test for non-normally distributed outcomes Multiple linear regression will be used to identify independent predictors of M-FIM at discharge M-FIMeffectiveness and handgrip strength The assumption of linearity between the outcome and continuous predictors will be assessed using the Box-Tidwell test Where there is evidence of non-linearity the investigators will use a restricted cubic spline function with three knots at the 10th 50th and 90th percentiles to model the relationship between continuous predictor and the outcome Assumptions of homoscedasticity and normality of errors will be assessed using residual and Q-Q plots respectively The investigators will check for multicollinearity using the variance inflation factor VIF Beta coefficients with corresponding 95 confidence intervals CIs will be reported Statistical tests will be two-sided with a 005 significance level All statistical analyses will be conducted using IBM SPSS Statistics version 230 IBM Corp Armonk NY USA No interim analysis is necessary as the study is not conceptualised as a randomised controlled trial
WITHDRAWAL FROM THE STUDY Subjects may withdraw voluntarily from participation in the study at any time including after discharge with no prejudice to their clinical care or outpatient follow-up Their data will be removed from the electronic records and the hardcopy data collection form will be physically destroyed Their withdrawal will be reported in the STROBE flowchart subsequently
DISCONTINUATION OF THE STUDY The study may be discontinued for any of the following reasons
1 Adverse event or serious adverse event related to data collection or study conduct which implicates safety of subsequent recruits
2 Breakdown of the BIA machine with no cost-effective repair or replacement option available
3 Other unforeseen circumstances In the event of study discontinuation the investigators will inform the CIRB accordingly and the study team will evaluate the incomplete data to determine if there is sufficient scholarly merit remaining to justify write-up and publication
SAFETY MONITORING PLAN Patients will be under the care of a trained study team member during clinical measurements who will be expected to safely operate the different measuring devices dynamometer and BIA machine They will be monitored for pain and discomfort during use of the devices Other clinical deteriorations will be managed routinely Data will be reviewed on a monthly basis by an appointed co-investigator for integrity as well as completion This includes screening and recruitment figures as well as demographic anthropometric and clinical measurements as well as functional outcomes Data safety will be through lock-and-key storage of physical documents as well as access-restricted password-protection for electronic data which can only be viewed on the hospitals intranet-facing devices
DATA ENTRY AND STORAGE Demographic data will be collected from patients electronic medical records Anthropometric and clinical measurements will be collected physically All records will be recorded in a hardcopy data collection form to be filed in the Investigator Site File ISF that is stored under lock-and-key in the Research Office All data will be transcribed electronically into REDCap which is hosted on the hospitals intranet and is access-restricted as well as password-protected Only study team members including the clinical research co-ordinator will have access to the data Data will be de-identified prior to analysis by the statistician All data will be kept for 7 years post-completion or post-publication whichever is later Following that electronic data will be deleted and all paper records will be physically destroyed
DATA QUALITY ASSURANCE All data will be collected by a small pre-defined group of trained medical doctors and clinical research co-ordinators with medical backgrounds All study team members will be pre-trained and briefed on the use of the clinical measurement devices Anthropometric measurements of height weight and BMI will be collected by the inpatient ward nurses during patients hospitalisation FIM is documented on a weekly basis by the inpatient clinical teams after discussion with the multidisciplinary team All study team members will have previous training and experience in accessing the patients electronic medical records
ETHICAL CONSIDERATIONS This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the Good Clinical Practice and the applicable regulatory requirements The principal investigator is responsible for informing the CIRB of any amendments to the protocol or other study-related documents as per local requirement
INFORMED CONSENT Patients will be referred by the primary team Eligible patients would then be approached for consent while they are inpatient within 48 work hours of transfer in to the unit All study team members would be trained and hence eligible for consent-taking Consent will be taken physically and in writing Risks and benefits of participation will be clearly explained Patients will be given ample time to make a decision andor decline with no impact on their standard of clinical care If a family members presence is requested or deemed necessary but they cannot be present at the bedside the investigators will consider remote consent-taking per the cluster guidance document on Guidance on Remote Consent Process and Documentation for Research A witness will not be required for all consent-taking as the study does not involve invasive procedures Upon enrolment into the study a note will be entered into the patients electronic medical record For non-English speakers the investigators will use appropriate translation in Mandarin Malay or Tamil with the assistance of a translator where necessary A witness will be present Patients with cognitive impairment may be recruited as this may be a sequela of their acute stroke or they may have underlying impairments The study team member assessing for cognitive impairment would have been satisfactorily trained prior They will be treated as vulnerable population if unable to participate in the consent-taking and research process as per the Mental Capacity Act 2008 The investigators do not foresee the recruitment of other special populations such as children prisoners or other vulnerable individuals In obtaining and documenting informed consent the investigator should comply with the GCP guidelines and to the ethical principles that have their origin in the Declaration of Helsinki
STUDY POPULATION Consecutive purposive sample of all patients with stroke deconditioning lung disease or amputation admitted to the CGH Rehabilitation Medicine unit
CONDUCT OF STUDY The study will take place in the main inpatient ward of the CGH Rehabilitation Medicine unit All patients transferred in for inpatient rehabilitation will undergo case note screening and physical examination as part of their routine post-transfer clerking Patients fulfilling the inclusion and exclusion criteria will be approached for recruitment and enrolment within 48 work hours of transfer in to the unit Baseline measurements will be collected and they will undergo usual rehabilitation with the hospitals multidisciplinary team Repeat measurements will also be collected upon discharge
DATA COLLECTION
Patient data will be collected upon consent including
1 Demographic data
1 Age ethnicity and gender
2 Handedness
3 Occupation and employment status
4 Highest education level
5 Living arrangements and housing type
2 Anthropometric data
1 Height and body mass index BMI
2 BIA measures of appendicular skeletal mass ASM phase angle PhA and percentage body fat PBF - measured twice and at least 15mins apart
3 Functional data
1 Premorbid mobility
2 Activities of daily living by the Katz Index
3 Functional Independence Measure FIM
4 Clinical data
1 Diagnosis group
2 Charlson Comorbidity Index
3 Intrinsic capacity measures per the Integrated Care for Older People screening guidance ICOPE
4 Sarcopenia measured by the SARC-CalF tool
5 Frailty measured by CFS and the FRAIL questionnaire
6 Cognition by the Chinese version 28 marks of the Mini-Mental State Examination MMSE
7 Mood by the Hospital Anxiety and Depression Scale HADS
8 Nutrition by the Mini Nutritional Assessment Short-Form MNA-SF
9 Quality of Life by the 5-item EuroQOL 5-dimension questionnaire EQ-5D-5L
10 Handgrip strength - measured twice
11 Average medial gastrocnemius thickness by ultrasonography
12 Routine blood test results if done prior of white cell count C-reactive protein albumin iron saturation and Vitamin D
5 Physical performance data
1 10-metre walk test
2 5-times sit-to-stand test
On discharge the following will be collected
1 Anthropometric data
1 Updated body mass index BMI
2 BIA measures of ASM PhA and PBF
2 Clinical data
1 Mood by the Hospital Anxiety and Depression Scale HADS
2 Quality of Life by the 5-item EuroQOL 5-dimension questionnaire EQ-5D-5L
3 Handgrip strength
3 Physical performance data
1 10-metre walk test
2 5-times sit-to-stand test
4 Administrative data a Length of stay by total duration and segmental stays in the acute and rehabilitation settings respectively b Confounders that could have affected rehabilitation adherence or participation occurrence during stay of i Acute transient or irreversible cognitive dysfunction ii Mood dysfunction iii Moderatesevere pain and iv Low patient self-efficacy All tools and questionnaires used are validated and included in many clinical guidelines both local and international
SUBGROUP ANALYSIS
The investigators will perform subgroup analysis along 3 phenotypes
1 Admitting diagnosis group strokes deconditioning pulmonary and lower limb amputee
2 Frailty status frail at-risk and non-frail patients as defined by CFS scores of 5 4 and 3 respectively
3 Age 60yrs and 60yrs
STATISTICAL AND ANALYTICAL PLANS Descriptive statistics of patient demographic and clinical characteristics will be reported as number and percent for categorical data mean SD for normally distributed data and median and interquartile range IQR for non-normally distributed data Intergroup comparisons will be made using the χ²Fishers exact test for categorical outcomes unpaired t-test for normally distributed outcomes and Mann-Whitney U-test for non-normally distributed outcomes Multiple linear regression will be used to identify independent predictors of M-FIM at discharge M-FIMeffectiveness and handgrip strength The assumption of linearity between the outcome and continuous predictors will be assessed using the Box-Tidwell test Where there is evidence of non-linearity the investigators will use a restricted cubic spline function with three knots at the 10th 50th and 90th percentiles to model the relationship between continuous predictor and the outcome Assumptions of homoscedasticity and normality of errors will be assessed using residual and Q-Q plots respectively The investigators will check for multicollinearity using the variance inflation factor VIF Beta coefficients with corresponding 95 confidence intervals CIs will be reported Statistical tests will be two-sided with a 005 significance level All statistical analyses will be conducted using IBM SPSS Statistics version 230 IBM Corp Armonk NY USA No interim analysis is necessary as the study is not conceptualised as a randomised controlled trial
WITHDRAWAL FROM THE STUDY Subjects may withdraw voluntarily from participation in the study at any time including after discharge with no prejudice to their clinical care or outpatient follow-up Their data will be removed from the electronic records and the hardcopy data collection form will be physically destroyed Their withdrawal will be reported in the STROBE flowchart subsequently
DISCONTINUATION OF THE STUDY The study may be discontinued for any of the following reasons
1 Adverse event or serious adverse event related to data collection or study conduct which implicates safety of subsequent recruits
2 Breakdown of the BIA machine with no cost-effective repair or replacement option available
3 Other unforeseen circumstances In the event of study discontinuation the investigators will inform the CIRB accordingly and the study team will evaluate the incomplete data to determine if there is sufficient scholarly merit remaining to justify write-up and publication
SAFETY MONITORING PLAN Patients will be under the care of a trained study team member during clinical measurements who will be expected to safely operate the different measuring devices dynamometer and BIA machine They will be monitored for pain and discomfort during use of the devices Other clinical deteriorations will be managed routinely Data will be reviewed on a monthly basis by an appointed co-investigator for integrity as well as completion This includes screening and recruitment figures as well as demographic anthropometric and clinical measurements as well as functional outcomes Data safety will be through lock-and-key storage of physical documents as well as access-restricted password-protection for electronic data which can only be viewed on the hospitals intranet-facing devices
DATA ENTRY AND STORAGE Demographic data will be collected from patients electronic medical records Anthropometric and clinical measurements will be collected physically All records will be recorded in a hardcopy data collection form to be filed in the Investigator Site File ISF that is stored under lock-and-key in the Research Office All data will be transcribed electronically into REDCap which is hosted on the hospitals intranet and is access-restricted as well as password-protected Only study team members including the clinical research co-ordinator will have access to the data Data will be de-identified prior to analysis by the statistician All data will be kept for 7 years post-completion or post-publication whichever is later Following that electronic data will be deleted and all paper records will be physically destroyed
DATA QUALITY ASSURANCE All data will be collected by a small pre-defined group of trained medical doctors and clinical research co-ordinators with medical backgrounds All study team members will be pre-trained and briefed on the use of the clinical measurement devices Anthropometric measurements of height weight and BMI will be collected by the inpatient ward nurses during patients hospitalisation FIM is documented on a weekly basis by the inpatient clinical teams after discussion with the multidisciplinary team All study team members will have previous training and experience in accessing the patients electronic medical records
ETHICAL CONSIDERATIONS This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the Good Clinical Practice and the applicable regulatory requirements The principal investigator is responsible for informing the CIRB of any amendments to the protocol or other study-related documents as per local requirement
INFORMED CONSENT Patients will be referred by the primary team Eligible patients would then be approached for consent while they are inpatient within 48 work hours of transfer in to the unit All study team members would be trained and hence eligible for consent-taking Consent will be taken physically and in writing Risks and benefits of participation will be clearly explained Patients will be given ample time to make a decision andor decline with no impact on their standard of clinical care If a family members presence is requested or deemed necessary but they cannot be present at the bedside the investigators will consider remote consent-taking per the cluster guidance document on Guidance on Remote Consent Process and Documentation for Research A witness will not be required for all consent-taking as the study does not involve invasive procedures Upon enrolment into the study a note will be entered into the patients electronic medical record For non-English speakers the investigators will use appropriate translation in Mandarin Malay or Tamil with the assistance of a translator where necessary A witness will be present Patients with cognitive impairment may be recruited as this may be a sequela of their acute stroke or they may have underlying impairments The study team member assessing for cognitive impairment would have been satisfactorily trained prior They will be treated as vulnerable population if unable to participate in the consent-taking and research process as per the Mental Capacity Act 2008 The investigators do not foresee the recruitment of other special populations such as children prisoners or other vulnerable individuals In obtaining and documenting informed consent the investigator should comply with the GCP guidelines and to the ethical principles that have their origin in the Declaration of Helsinki
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