Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605066
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Post-Operative Physical Activity Monitoring Algorithm Performance and Clinical Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-Operative Physical Activity Monitoring Algorithm Performance and Clinical Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 goal of this observational study is to validate physical activity algorithms in post-operative populations through raw accelerometer data collection using the ADI Study Watch 45 while in an in-patient setting The secondary objective of the study is to collect skin temperature photoplethysmography PPG Bioimpedance Analysis BIA heart rate HR SpO2 and electrodermal activity EDA using the ADI Study Watch 45 The main questions it aims to answer are
Can a wearable physical activity monitoring device assess patients39 activity levels with higher accuracy and precision compared to traditional physical activity monitoring methods during the post-operative period
Do wearable devices placed on different body regions perform similarly in tracking physical activity during the post-operative period
Do post-operative physical activity monitoring algorithms improve patient compliance accelerate recovery and reduce hospital stay duration
Analysis of the activity tracking performance of a consumer device Apple Watch in patients after cardiac and thoracic surgery
Can a wearable physical activity monitoring device assess patients39 activity levels with higher accuracy and precision compared to traditional physical activity monitoring methods during the post-operative period
Do wearable devices placed on different body regions perform similarly in tracking physical activity during the post-operative period
Do post-operative physical activity monitoring algorithms improve patient compliance accelerate recovery and reduce hospital stay duration
Analysis of the activity tracking performance of a consumer device Apple Watch in patients after cardiac and thoracic surgery
Detailed Description:
Participants After obtaining ethical approval individuals meeting the inclusion criteria will be enrolled in the study at BAİBÜ Izzet Baysal Training and Research Hospital After providing participants with information about the study they will be asked to sign an informed consent form The total sample size for the preliminary t-test analysis was determined to be 42 with an alpha of 005 a power of 080 and a medium effect size using the GPower ver 3197 program Anticipating a 40 drop-out rate 60 individuals will be included in the study To determine the final sample size a power analysis will be performed using data obtained from the study
Assessment Methods The demographic information of the participants will be collected using the Participant Identification Form Pre-operative physical condition will be evaluated with the ASA Physical Status Classification System skin color with the Fitzpatrick Skin Type Scale pain level while resting coughing and moving will be assessed using the Visual Analog Scale VAS fatigue and anxiety with VAS functional walking capacity with the 6-Minute Walk Test physical activity level with the International Physical Activity Questionnaire fear of movement with the TAMPA Scale of Kinesiophobia and quality of life with the SF-36 Short Form
The evaluation forms applied to the participants consist of the following sections
1 Participant Identification Form 2 ASA Score 3 Fitzpatrick Skin Type Scale 4 Symptoms VAS 0-10 5 Six-Minute Walk Test 6 International Physical Activity Questionnaire 7 TAMPA Scale of Kinesiophobia
1 Participant Identification Questions
In the questionnaire the following questions will be asked to determine the characteristics of the participants
Name-Surname Gender Date of Birth Height Weight Type of surgery Arm length Step length Wrist circumference Smoking Participants will be asked whether they smoke and the data will be recorded in pack-years Educational level After verbally asking participants about their educational level it will be recorded as illiterate primary school middle school high school or university Employment status Participants39 occupations will be asked verbally and recorded as housewife employed or retired Medical history Participants will be asked whether they have any chronic illnesses or have undergone surgery before Medications Participants will be asked whether they take any medications regularly and the data will be recorded
2 ASA Physical Status Classification System
The ASA system classifies patients39 physical conditions before surgery as follows
ASA 1 A healthy and normal person with no disease or systemic disorder other than a surgical pathology that does not cause systemic dysfunction
ASA 2 A person with a systemic disorder caused by a surgical condition or a disease such as mild emphysema chronic bronchitis diabetes hypertension or anemia
ASA 3 A person with a disease that limits activity but is not incapacitating such as heart failure a previous myocardial infarction hypovolemia advanced diabetes or limited lung function
ASA 4 A person with a disease such as respiratory disease kidney or liver failure that severely impairs physical ability and poses a constant threat to life
ASA 5 A moribund person not expected to survive 24 hours without surgery ASA 6 This group includes brain-dead patients who are suitable for organ donation
3 Fitzpatrick Skin Type Scale
Participants39 skin types will be categorized into six groups from very fair skin type I to very dark skin type VI according to the Fitzpatrick Skin Type Scale which is commonly used in the literature to determine skin type Skin type is characterized by general appearance eye color hair type and color etc
Type I - Very fair skin sensitive to the sun light eye color bluegreen blonde or light brown hair
Type II - Fair skin light brown or brown hair light-colored eyes Type III - Fair to wheatish skin light or dark eyes brown or black hair Type IV - Wheatish skin dark eyes brownblack brown or black hair Type V - Dark brown skin dark black eyes black hair Type VI - Very dark skin almost black black eyes black hair
4 Visual Analog Scale VAS
Pain levels will be assessed using the VAS According to the VAS pain severity is generally rated on a 0-10 cm scale with 34no pain34 being 0 and 34the worst pain imaginable34 being 10 Pain severity categories are
lt3 mild pain 3-6 moderate pain 6 severe pain
5 Six-Minute Walk Test 6MWT
As an easily applicable and objective assessment the 6MWT is the most widely used cardiopulmonary exercise test Participants are asked to walk the longest possible distance in a straight corridor marked at 30 meters during six minutes Before and after the test heart rate blood pressure and oxygen saturation SpO2 will be measured dyspnea will be recorded using the Modified Borg Scale The distance walked in six minutes will be noted in meters A distance of less than 300 meters is associated with higher mortality The normal range for healthy individuals is between 500 and 700 meters The expected 6MWT distance will be calculated using the following formulas
Male 757 X heightcm - 502 X age - 176 X weightkg - 309 Female 211 X heightcm - 229 X weightkg - 578 X age 667
6 International Physical Activity Questionnaire Short Form
Developed by Craig in 2003 to assess physical activity levels in adults the reliability and validity of this questionnaire were tested by Sağlam et al in 2010 It assesses the types of physical activity individuals have performed in the past seven days and the time spent on each activity It consists of seven questions and the total score is calculated by multiplying the duration minutes and frequency days of moderate and vigorous activities Patients are classified as inactive lt600 MET minweek moderately active 600-3000 MET minweek or active gt3000 kcalmin
7 TAMPA Scale of Kinesiophobia
This is a 17-item self-report scale developed to measure fear of movement Scores range from 17 to 68 Higher scores indicate greater fear of movement while lower scores suggest minimal fear
Participants who meet the inclusion criteria will wear the sensors for 5 hours after discharge from the ward During this time they are free to engage in natural activities During data collection the ADI Study Watch 45 will be worn on the left wrist arm and chest the Apple Watch 8 will be worn on the right arm and the Axivity AX6 on the ankle
Statistics Descriptive statistics will be presented as mean and standard deviation for numerical variables or median and minimum-maximum values Categorical variables will be described as numbers and percentages The Shapiro-Wilk test will be used to assess normality An independent t-test will be used to compare two groups when assumptions are met and the Mann-Whitney U test will be used when assumptions are not met Correlations between parameters will be examined using Spearman or Pearson correlation analysis depending on normality Chi-square tests will be used to examine differences between categorical variables The significance level will be set at plt005 Data analysis will be performed using the Statistical Package for the Social Sciences SPSS v20
Assessment Methods The demographic information of the participants will be collected using the Participant Identification Form Pre-operative physical condition will be evaluated with the ASA Physical Status Classification System skin color with the Fitzpatrick Skin Type Scale pain level while resting coughing and moving will be assessed using the Visual Analog Scale VAS fatigue and anxiety with VAS functional walking capacity with the 6-Minute Walk Test physical activity level with the International Physical Activity Questionnaire fear of movement with the TAMPA Scale of Kinesiophobia and quality of life with the SF-36 Short Form
The evaluation forms applied to the participants consist of the following sections
1 Participant Identification Form 2 ASA Score 3 Fitzpatrick Skin Type Scale 4 Symptoms VAS 0-10 5 Six-Minute Walk Test 6 International Physical Activity Questionnaire 7 TAMPA Scale of Kinesiophobia
1 Participant Identification Questions
In the questionnaire the following questions will be asked to determine the characteristics of the participants
Name-Surname Gender Date of Birth Height Weight Type of surgery Arm length Step length Wrist circumference Smoking Participants will be asked whether they smoke and the data will be recorded in pack-years Educational level After verbally asking participants about their educational level it will be recorded as illiterate primary school middle school high school or university Employment status Participants39 occupations will be asked verbally and recorded as housewife employed or retired Medical history Participants will be asked whether they have any chronic illnesses or have undergone surgery before Medications Participants will be asked whether they take any medications regularly and the data will be recorded
2 ASA Physical Status Classification System
The ASA system classifies patients39 physical conditions before surgery as follows
ASA 1 A healthy and normal person with no disease or systemic disorder other than a surgical pathology that does not cause systemic dysfunction
ASA 2 A person with a systemic disorder caused by a surgical condition or a disease such as mild emphysema chronic bronchitis diabetes hypertension or anemia
ASA 3 A person with a disease that limits activity but is not incapacitating such as heart failure a previous myocardial infarction hypovolemia advanced diabetes or limited lung function
ASA 4 A person with a disease such as respiratory disease kidney or liver failure that severely impairs physical ability and poses a constant threat to life
ASA 5 A moribund person not expected to survive 24 hours without surgery ASA 6 This group includes brain-dead patients who are suitable for organ donation
3 Fitzpatrick Skin Type Scale
Participants39 skin types will be categorized into six groups from very fair skin type I to very dark skin type VI according to the Fitzpatrick Skin Type Scale which is commonly used in the literature to determine skin type Skin type is characterized by general appearance eye color hair type and color etc
Type I - Very fair skin sensitive to the sun light eye color bluegreen blonde or light brown hair
Type II - Fair skin light brown or brown hair light-colored eyes Type III - Fair to wheatish skin light or dark eyes brown or black hair Type IV - Wheatish skin dark eyes brownblack brown or black hair Type V - Dark brown skin dark black eyes black hair Type VI - Very dark skin almost black black eyes black hair
4 Visual Analog Scale VAS
Pain levels will be assessed using the VAS According to the VAS pain severity is generally rated on a 0-10 cm scale with 34no pain34 being 0 and 34the worst pain imaginable34 being 10 Pain severity categories are
lt3 mild pain 3-6 moderate pain 6 severe pain
5 Six-Minute Walk Test 6MWT
As an easily applicable and objective assessment the 6MWT is the most widely used cardiopulmonary exercise test Participants are asked to walk the longest possible distance in a straight corridor marked at 30 meters during six minutes Before and after the test heart rate blood pressure and oxygen saturation SpO2 will be measured dyspnea will be recorded using the Modified Borg Scale The distance walked in six minutes will be noted in meters A distance of less than 300 meters is associated with higher mortality The normal range for healthy individuals is between 500 and 700 meters The expected 6MWT distance will be calculated using the following formulas
Male 757 X heightcm - 502 X age - 176 X weightkg - 309 Female 211 X heightcm - 229 X weightkg - 578 X age 667
6 International Physical Activity Questionnaire Short Form
Developed by Craig in 2003 to assess physical activity levels in adults the reliability and validity of this questionnaire were tested by Sağlam et al in 2010 It assesses the types of physical activity individuals have performed in the past seven days and the time spent on each activity It consists of seven questions and the total score is calculated by multiplying the duration minutes and frequency days of moderate and vigorous activities Patients are classified as inactive lt600 MET minweek moderately active 600-3000 MET minweek or active gt3000 kcalmin
7 TAMPA Scale of Kinesiophobia
This is a 17-item self-report scale developed to measure fear of movement Scores range from 17 to 68 Higher scores indicate greater fear of movement while lower scores suggest minimal fear
Participants who meet the inclusion criteria will wear the sensors for 5 hours after discharge from the ward During this time they are free to engage in natural activities During data collection the ADI Study Watch 45 will be worn on the left wrist arm and chest the Apple Watch 8 will be worn on the right arm and the Axivity AX6 on the ankle
Statistics Descriptive statistics will be presented as mean and standard deviation for numerical variables or median and minimum-maximum values Categorical variables will be described as numbers and percentages The Shapiro-Wilk test will be used to assess normality An independent t-test will be used to compare two groups when assumptions are met and the Mann-Whitney U test will be used when assumptions are not met Correlations between parameters will be examined using Spearman or Pearson correlation analysis depending on normality Chi-square tests will be used to examine differences between categorical variables The significance level will be set at plt005 Data analysis will be performed using the Statistical Package for the Social Sciences SPSS v20
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