Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429423
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-02-06
Brief Title:
Effects of Acute Physical Activity in Patients With Exhaustion Disorder
Sponsor:
Victoria Blom
Organization:
The Swedish School of Sport and Health Sciences
Study Overview
Official Title:
Acute Psychological and Physiological Exercise Effects Among Patients With Stress-related Exhaustion Disorder Role of Exercise Intensity
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A new stress-related diagnosis Exhaustion disorder ED was introduced in the Swedish version of ICD-10 in 2005 and has since then increased rapidly The condition is long-lasting and debilitating characterized by considerable and persistent fatigue insomnia and impaired cognitive function The diagnosis is still relatively unexplored and there is no consistent knowledge of among other things which interventions that work Research indicates that physical activity can have positive effects on depression anxiety and stress However there is little knowledge today about the relationship between the dose of physical activity and stress-related illness It is also not clear how physical activity can be used in the treatment of stress-related illness The purpose of this project is to gain increased knowledge about the immediate physiological and psychological effects of physical activity for people with diagnosed ED The project will investigate the psychological and physiological effects of two different intensities of physical activity in people with ED compared to healthy controls The information from the study also aims to provide a basis for a second part of the project where treatment including physical activity is carried out with people with ED in a randomized controlled design
Detailed Description:
Background A new stress-related diagnosis exhaustion disorder ED was introduced in the Swedish version of ICD-10 in 2005 and has since then increased rapidly The condition is long-lasting and debilitating characterized by considerable and persistent fatigue insomnia and impaired cognitive function The diagnosis is still relatively unexplored and there is no consistent knowledge of among other things which interventions that work
There is extensive research on the association between mental health and physical activity in general and exercise specifically When it comes to long-term or habitual exercise it is established that it has beneficial effects on different aspects of mental health and physical activity interventions are helpful for people with mental illness The most widely studied mental health-issues are depression anxiety and stress and a recent umbrella review concludes that habitual exercise is beneficial for symptom reduction for depression anxiety and stress across different populations Epidemiological evidence shows that physical activity is associated with lowered risk of experiencing fatigue and reduced energy
Little is known about how physical activity in general and more specifically different intensities of physical activity affects people with ED Does it have adverse effects or is it beneficial This is imperative when it comes to intervention- and treatment planning for these patients No studies have been done specifically on ED before with this focus Although an acute study cannot show the optimal physical activity program it can give insight into the relation between between ED and exercise This in turn can help us construct better designs of exercise programs for this patient group
Research aims and questions The purpose of the study is to gain increased understanding of the psychological and physiological response to acute exercise in ED-patients compared to a healthy population and to determine if that response differs between two different intensities of exercise low and moderate The focus is on transient emotional states and how they might fluctuate in response to exercise Specifically subjective feelings of fatigue energy anxiety psychological discomfort perceived exertion recovery and stress is studied Salivary cortisol and heart rate variability HRV are the biomarkers in focus
Knowledge from the study is planned to be used in the designing of a physical activity program as part of a treatment program for ED The design can give us information about whether short bouts of exercise can have mood-altering effects in this patient group and auonomic reactivity to physical activity
Research questions
1 Does level of fatigue vigorenergy state anxiety and perceived stress differ between groups EDcontrols andor between exercise intensities mildmoderate andor between timepoints prepost30minpost6hpost24hpost
2 Does the level of subjective discomfort and perceived exertion differ between groups EDcontrols andor between exercise intensities mildmoderate andor between time points pre5min10min15min
3 Does the level of salivary cortisol differ between groups EDcontrols andor between exercise intensities mildmoderate andor between time points prepost30 min post
4 Does level of heart rate variability HRV differ between groups EDcontrols andor between exercise intensities mildmoderate andor between timepoints prepost30minpost6hpost24hpost
If significant differences are found intercation effects between the different variables will also be studied as well as potential moderating variables
Methods Study design The design is a two-armed trial low and moderate intensity of physical activity with two groups one which is patients with ED and the other an age- and sex matched control group with overall healthy individuals that include sequential assessments of fatigue and energy states stress perceived exertion perceived psychological distress and state anxiety
Participants Approximately 30 patients with diagnosed exhaustion disorder F438A in ICD-10-SE and 30 age- and sex-matched healthy control participants are recruited for the study ED-patients are recruited through occupational health care Avonova and through advertisement in social media Facebook and Instagram Inclusion criteria in the studies for ED-patients confirmed primary diagnosis ED by a physician assessed to not be in the acute phase of ED age of 35-55 years considered by a physician andor a psychologist as suitable for participating in a study including performing physical activity Healthy control participants are recruited via the same social media channels as ED-patients Inclusion criteria age of 35-55 years self-reported good health no known somatic or psychiatric disease considered as suitable for participating in a study including performing physical activity Mini International Neuropsychiatric Interview 600 MINI as well as an additional diagnostic questionnaire targeting stress-related disorders based on diagnostic criteria from ICD-11 will be conducted with both ED-patients and healthy controls to ensure the inclusion- and exclusion criteria MINI is a diagnostic interview for the major DSM-IV psychiatric disorders The participants will receive thorough written information about the study and written informed consent will be obtained before inclusion The study was approved by the Regional Ethical Review Board in Linköping Sweden Approval Nr 2022-04943-01 and will be conducted in accordance with the ethical principles of the Declaration of Helsinki
Procedure The study takes place in a laboratory setting at GIH on three different days separated by at least one week Before enrollment participants complete an online administered screening questionnaire measuring exhaustion burnout and diagnostic and general health information Eligible participants are invited to GIH for a familiarization visit where a structured clinical interview MINI and stress diagnoses questionnaire is performed Participants will also complete a submaximal cardiorespiratory fitness test CRF to estimate maximal aerobic capacity The test is performed on a calibrated mechanically braked cycle ergometer model 828E Monark Varberg Sweden for 8 min Pedal frequency throughout the test is 60 rpm Cycling resistance starts at 05 kilopond kp for 4 minutes and is increased to a personalized higher work rate which lasts for 4 minutes VO2max is estimated from these 8 minutes using heart rate data collected during the test The result on this test will be used in determining each participants correct intensity level on the two trial conditions
Conditions The two trial conditions are performed in a counter-balanced and randomly assigned order The participants perform the two conditions of physical activity bouts at approximately the same time in the morningforenoon start time of test visit is either 830 or 1030 am with at least one week in between conditions The participants have the same test start time at the two test visits At each test session participants perform a 22-minute exercise on a cycle ergometer model 839E Monark Varberg Sweden Immediately before and at three time points during the exercise after 5 10 and 15 minutes on the low or moderate intensity they rate level of exertion RPE and feelings of psychological distress on a VAS-scale Immediately before immediately after 30 minutes after 6 hours after and 24 hours after exercise participants fill out questionnaires regarding feelings of fatigue energy anxiety recovery and stress Participants wear a H10 heart rate sensor and Vantage M2 monitor Polar Kempele Finland for a little more than 24 hours starting approximately 30 minutes before the exercise HRV parameters will be calculated from 5-min window recordings using the software Kubios HRV University of Eastern Finland Kuopio Finland immediately before pre immediately after post 30 minutes after 30 min post 6 hours after 6h post and 24 hours after 24h post exercise Since HRV is influenced by several factors caffeine intake alcohol consumption circadian rhythm stress both mental and physical exercise food- and water intake certain medications bladder filling respiratory rate and posture these factors will be controlled for when at GIH Salivary cortisol is collected pre post and 30 min post exercise using Sarstedt Salivette Cortisol Sarstedt Nümbrecht Germany The follow-up measurements will determine the trajectory of the cortisol and HRV post-exercise During the 24 hours following the exercise bout physical activity pattern is measured using a hip-worn accelerometer Actigraph GT3X Accelerometer data will be processed in Actilife
There are two experimental exercise conditions where participants will exercise at two different intensity levels The intensity levels are standardized across participants by using results from EKBLOM-BAK test to determine a low and moderate intensity Low intensity is defined as 40 and moderate intensity is defined as 55 of the participants individual estimated VO2max The 22-minute exercise starts with a 6-minute warm-up with a load increase after 1 and 3 minutes and lowered load at the last minute Then follows a 15-minute bout on either low or moderate intensity that ends with a 1-minute cool-down One of the researchers will be present during the complete test to assure correct intensity and length
Baseline measures
In the week before the familiarization visit each participant completes a digitally administered questionnaire that includes socio-demographic and general health information together with the following questionnaires
Exhaustion disorder Karolinska Exhaustion Disorder Scale KEDS was developed for the assessment of ED symptoms It consists of nine items with a scale range of 0-54 and a cut-off of 19 has been proposed in the discrimination between healthy subjects and patients with ED
Burnout Shirom-Melamed Burnout QuestionnaireMeasure SMBQSMBM is widely used in measuring burnout SMBM-12 is a short version with twelve items which captures core concepts of burnout emotional and physiological exhaustion eg I feel tired and cognitive weariness eg I feel I am not thinking clearly A global score of burnout is calculated SMBM-12 has good composite reliability and convergent validity
Trait anxiety The trait subscale of The State-Trait Anxiety Inventory STAI Respondents rate how they generally feel on a 4-point Likert Scale eg I feel nervous and rested A global score of a general and enduring trait anxiety is calculated
Depression Patient Health Questionnaire PHQ-9 measures depression in line with DSM-IV Respondents rate depression symptoms the last two weeks on a 4-point Likert Scale eg Little interest or pleasure in doing things
Sleep Pittsburgh Sleep Quality Index PSQI is widely used in measuring sleep quality It consists of 19 items that form seven components of retrospective sleep quality 1 month and a global score
Physical activity Saltin-Grimby Physical Activity Level Scale SGPALS is a four-level single-item instrument which has acceptable validity for measuring level of physical activity
Exercise attitudes Two subscales of the Exercise BenefitsBarriers Scale EBBS were included Psychological Outlook Subscale benefits and Physical Exertion Subscale barriers
2-3 days after the familiarization visit heart rate variability HRV and physical activity pattern is measured during a 24-hour baseline measurement Participants get oral and written instructions on the familiarization visit on how to initialize and conduct this measurement with a H10 heart rate sensor and Vantage M2 monitor together with a hip-worn accelerometer Actigraph GT3X Twice during the 24h-measurement digital questionnaires including Single Item stress Question SISQ the vigor and fatigue subscales of Profile of Mood States POMS single-item recovery question and state subscale of The State-Trait Anxiety Inventory STAI-Y1 are completed
Data analysis For each of the psychological variables perceived exertion psychological discomfort fatigue energyvigor state anxiety and stress a three factorial group time intensity ANOVA with repeated measures design will be the first hand choice if parametric assumptions are met A secondary stratified analysis will be performed exploring potential variables that influenced the primary and secondary psychological variables
For the data analysis of physiological variables data analysis are yet to be decided This will be done though before looking at the data
There is extensive research on the association between mental health and physical activity in general and exercise specifically When it comes to long-term or habitual exercise it is established that it has beneficial effects on different aspects of mental health and physical activity interventions are helpful for people with mental illness The most widely studied mental health-issues are depression anxiety and stress and a recent umbrella review concludes that habitual exercise is beneficial for symptom reduction for depression anxiety and stress across different populations Epidemiological evidence shows that physical activity is associated with lowered risk of experiencing fatigue and reduced energy
Little is known about how physical activity in general and more specifically different intensities of physical activity affects people with ED Does it have adverse effects or is it beneficial This is imperative when it comes to intervention- and treatment planning for these patients No studies have been done specifically on ED before with this focus Although an acute study cannot show the optimal physical activity program it can give insight into the relation between between ED and exercise This in turn can help us construct better designs of exercise programs for this patient group
Research aims and questions The purpose of the study is to gain increased understanding of the psychological and physiological response to acute exercise in ED-patients compared to a healthy population and to determine if that response differs between two different intensities of exercise low and moderate The focus is on transient emotional states and how they might fluctuate in response to exercise Specifically subjective feelings of fatigue energy anxiety psychological discomfort perceived exertion recovery and stress is studied Salivary cortisol and heart rate variability HRV are the biomarkers in focus
Knowledge from the study is planned to be used in the designing of a physical activity program as part of a treatment program for ED The design can give us information about whether short bouts of exercise can have mood-altering effects in this patient group and auonomic reactivity to physical activity
Research questions
1 Does level of fatigue vigorenergy state anxiety and perceived stress differ between groups EDcontrols andor between exercise intensities mildmoderate andor between timepoints prepost30minpost6hpost24hpost
2 Does the level of subjective discomfort and perceived exertion differ between groups EDcontrols andor between exercise intensities mildmoderate andor between time points pre5min10min15min
3 Does the level of salivary cortisol differ between groups EDcontrols andor between exercise intensities mildmoderate andor between time points prepost30 min post
4 Does level of heart rate variability HRV differ between groups EDcontrols andor between exercise intensities mildmoderate andor between timepoints prepost30minpost6hpost24hpost
If significant differences are found intercation effects between the different variables will also be studied as well as potential moderating variables
Methods Study design The design is a two-armed trial low and moderate intensity of physical activity with two groups one which is patients with ED and the other an age- and sex matched control group with overall healthy individuals that include sequential assessments of fatigue and energy states stress perceived exertion perceived psychological distress and state anxiety
Participants Approximately 30 patients with diagnosed exhaustion disorder F438A in ICD-10-SE and 30 age- and sex-matched healthy control participants are recruited for the study ED-patients are recruited through occupational health care Avonova and through advertisement in social media Facebook and Instagram Inclusion criteria in the studies for ED-patients confirmed primary diagnosis ED by a physician assessed to not be in the acute phase of ED age of 35-55 years considered by a physician andor a psychologist as suitable for participating in a study including performing physical activity Healthy control participants are recruited via the same social media channels as ED-patients Inclusion criteria age of 35-55 years self-reported good health no known somatic or psychiatric disease considered as suitable for participating in a study including performing physical activity Mini International Neuropsychiatric Interview 600 MINI as well as an additional diagnostic questionnaire targeting stress-related disorders based on diagnostic criteria from ICD-11 will be conducted with both ED-patients and healthy controls to ensure the inclusion- and exclusion criteria MINI is a diagnostic interview for the major DSM-IV psychiatric disorders The participants will receive thorough written information about the study and written informed consent will be obtained before inclusion The study was approved by the Regional Ethical Review Board in Linköping Sweden Approval Nr 2022-04943-01 and will be conducted in accordance with the ethical principles of the Declaration of Helsinki
Procedure The study takes place in a laboratory setting at GIH on three different days separated by at least one week Before enrollment participants complete an online administered screening questionnaire measuring exhaustion burnout and diagnostic and general health information Eligible participants are invited to GIH for a familiarization visit where a structured clinical interview MINI and stress diagnoses questionnaire is performed Participants will also complete a submaximal cardiorespiratory fitness test CRF to estimate maximal aerobic capacity The test is performed on a calibrated mechanically braked cycle ergometer model 828E Monark Varberg Sweden for 8 min Pedal frequency throughout the test is 60 rpm Cycling resistance starts at 05 kilopond kp for 4 minutes and is increased to a personalized higher work rate which lasts for 4 minutes VO2max is estimated from these 8 minutes using heart rate data collected during the test The result on this test will be used in determining each participants correct intensity level on the two trial conditions
Conditions The two trial conditions are performed in a counter-balanced and randomly assigned order The participants perform the two conditions of physical activity bouts at approximately the same time in the morningforenoon start time of test visit is either 830 or 1030 am with at least one week in between conditions The participants have the same test start time at the two test visits At each test session participants perform a 22-minute exercise on a cycle ergometer model 839E Monark Varberg Sweden Immediately before and at three time points during the exercise after 5 10 and 15 minutes on the low or moderate intensity they rate level of exertion RPE and feelings of psychological distress on a VAS-scale Immediately before immediately after 30 minutes after 6 hours after and 24 hours after exercise participants fill out questionnaires regarding feelings of fatigue energy anxiety recovery and stress Participants wear a H10 heart rate sensor and Vantage M2 monitor Polar Kempele Finland for a little more than 24 hours starting approximately 30 minutes before the exercise HRV parameters will be calculated from 5-min window recordings using the software Kubios HRV University of Eastern Finland Kuopio Finland immediately before pre immediately after post 30 minutes after 30 min post 6 hours after 6h post and 24 hours after 24h post exercise Since HRV is influenced by several factors caffeine intake alcohol consumption circadian rhythm stress both mental and physical exercise food- and water intake certain medications bladder filling respiratory rate and posture these factors will be controlled for when at GIH Salivary cortisol is collected pre post and 30 min post exercise using Sarstedt Salivette Cortisol Sarstedt Nümbrecht Germany The follow-up measurements will determine the trajectory of the cortisol and HRV post-exercise During the 24 hours following the exercise bout physical activity pattern is measured using a hip-worn accelerometer Actigraph GT3X Accelerometer data will be processed in Actilife
There are two experimental exercise conditions where participants will exercise at two different intensity levels The intensity levels are standardized across participants by using results from EKBLOM-BAK test to determine a low and moderate intensity Low intensity is defined as 40 and moderate intensity is defined as 55 of the participants individual estimated VO2max The 22-minute exercise starts with a 6-minute warm-up with a load increase after 1 and 3 minutes and lowered load at the last minute Then follows a 15-minute bout on either low or moderate intensity that ends with a 1-minute cool-down One of the researchers will be present during the complete test to assure correct intensity and length
Baseline measures
In the week before the familiarization visit each participant completes a digitally administered questionnaire that includes socio-demographic and general health information together with the following questionnaires
Exhaustion disorder Karolinska Exhaustion Disorder Scale KEDS was developed for the assessment of ED symptoms It consists of nine items with a scale range of 0-54 and a cut-off of 19 has been proposed in the discrimination between healthy subjects and patients with ED
Burnout Shirom-Melamed Burnout QuestionnaireMeasure SMBQSMBM is widely used in measuring burnout SMBM-12 is a short version with twelve items which captures core concepts of burnout emotional and physiological exhaustion eg I feel tired and cognitive weariness eg I feel I am not thinking clearly A global score of burnout is calculated SMBM-12 has good composite reliability and convergent validity
Trait anxiety The trait subscale of The State-Trait Anxiety Inventory STAI Respondents rate how they generally feel on a 4-point Likert Scale eg I feel nervous and rested A global score of a general and enduring trait anxiety is calculated
Depression Patient Health Questionnaire PHQ-9 measures depression in line with DSM-IV Respondents rate depression symptoms the last two weeks on a 4-point Likert Scale eg Little interest or pleasure in doing things
Sleep Pittsburgh Sleep Quality Index PSQI is widely used in measuring sleep quality It consists of 19 items that form seven components of retrospective sleep quality 1 month and a global score
Physical activity Saltin-Grimby Physical Activity Level Scale SGPALS is a four-level single-item instrument which has acceptable validity for measuring level of physical activity
Exercise attitudes Two subscales of the Exercise BenefitsBarriers Scale EBBS were included Psychological Outlook Subscale benefits and Physical Exertion Subscale barriers
2-3 days after the familiarization visit heart rate variability HRV and physical activity pattern is measured during a 24-hour baseline measurement Participants get oral and written instructions on the familiarization visit on how to initialize and conduct this measurement with a H10 heart rate sensor and Vantage M2 monitor together with a hip-worn accelerometer Actigraph GT3X Twice during the 24h-measurement digital questionnaires including Single Item stress Question SISQ the vigor and fatigue subscales of Profile of Mood States POMS single-item recovery question and state subscale of The State-Trait Anxiety Inventory STAI-Y1 are completed
Data analysis For each of the psychological variables perceived exertion psychological discomfort fatigue energyvigor state anxiety and stress a three factorial group time intensity ANOVA with repeated measures design will be the first hand choice if parametric assumptions are met A secondary stratified analysis will be performed exploring potential variables that influenced the primary and secondary psychological variables
For the data analysis of physiological variables data analysis are yet to be decided This will be done though before looking at the data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None