Fysiologische mechanismen van therapeutische interventie-effecten bij paardrijden in een psychiatrische populatie van ASS-jeugd
24 juli 2026 bijgewerkt door: University of Colorado, Denver
Fysiologische werkingsmechanismen met betrekking tot onmiddellijke en langdurige therapeutische interventie-effecten bij paardrijden in een psychiatrische populatie van jongeren met autismespectrumstoornis
Deze gerandomiseerde controlestudie (RCT) heeft tot doel de mechanismen te beoordelen die ten grondslag liggen aan Therapeutic Horseback Riding's (THR), eerder waargenomen significante positieve effecten op ASS-jongeren, met name die met gelijktijdig optredende psychiatrische stoornissen, en om informatie over de duurzaamheid, dosis en subpopulatie te verfijnen. effecten van de ingreep.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
Deze gerandomiseerde controleproef (RCT) zal de hypothese testen dat fysiologische responspatronen van speekselcortisol, cardiovasculaire en elektrodermale activiteit verantwoordelijk zijn voor onze eerder waargenomen significante uitkomsten (d.w.z. verminderde prikkelbaarheid en hyperactiviteit, en verbeterde sociale en communicatie), en aanvullende uitkomsten ( emotieregulatie kwaliteit van leven mantelzorger en crisisgebruik GGZ), bij jongeren van 6-16 jaar.
met ASS en gelijktijdig optredende psychiatrische diagnoses gerandomiseerd naar een handmatige THR-interventie van 10 weken in vergelijking met een Barn Activity (BA)-controle zonder paard (doel 1).
We zullen de duurzaamheid van Doel 1-uitkomsten in de THR-groep evalueren in vergelijking met de BA-controlegroep zes maanden na de interventieperiode (Doel 2).
Ten slotte zullen we dosis- en subpopulatie-effecten van THR- en BA-interventies onderzoeken door verschillen in effectgrootte in THR- en BA-groepen te vergelijken met (a) een wachtlijstcontrolegroep van 10 weken; (b) een hybride interventiegroep (vijf weken BA gevolgd door vijf weken THR); en (c) een deelsteekproef van de THR-studiepopulatie gerandomiseerd na opname in een psychiatrisch ziekenhuis (doel 3).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
236
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Colorado
-
Aurora, Colorado, Verenigde Staten, 80218
- University of Colorado Anschutz Medical Campus
-
-
Maine
-
Portland, Maine, Verenigde Staten, 04102
- Maine Health
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 jaar tot 17 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusiecriteria:
- gedocumenteerde ASS-diagnose en een gelijktijdig optredende psychiatrische stoornis
- ABC Prikkelbaarheid subschaalscore ≥8
- Leiter-III Non-verbaal IQ ≥ 40
- voldoen aan Symptom Criterion-score (minimaal aantal symptomen dat nodig is voor een DSM-V-diagnose (stemming, angst of ADHD) op CASI-5)
- voldoen aan ASS-cut-offs op de SCQ (≥ 11) en op ADOS-2
- Slechts één kind met ASS per gezin om onafhankelijke observaties te behouden
- een consistente verzorger (d.w.z. ouder of wettelijke voogd) om de studie-uitkomstmetingen te voltooien
Uitsluitingscriteria:
- medische of gedragsproblemen die deelname verhinderen
- eigendom van de staat
- beoordeeld tijdens het manegescherm om aanzienlijke rijervaring te hebben
- roken of regelmatig gebruik van orale, geïnhaleerde of lokale steroïden op regelmatige basis, factoren waarvan bekend is dat ze de cortisolspiegels beïnvloeden
- Deelnemers die 200 pond of meer wegen, worden uitgesloten vanwege het veiligheidsbeleid van de manege
- Deelnemers mogen niet met basislijnbeoordelingen beginnen totdat er ten minste zes maanden zijn verstreken vanaf het moment dat ze voor het laatst met gemonteerde EAAT bezig waren, gezien het bewijs van de proef voor het zes maanden durende behoud van THR-effecten.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Wachtlijst
Degenen die zijn toegewezen aan de wachtlijstgroep zullen gedurende een wachtperiode van 10 weken geen paardgerelateerde interventie ondergaan.
Na deze wachtperiode en de voltooiing van beoordelingen achteraf, beginnen deelnemers in deze toestand aan een hybride groep (zie hybride arm)
|
|
|
Experimenteel: Therapeutisch paardrijden
Deze Arm is een kleine groep van 10 weken van één uur (2-4 deelnemers) onder leiding van een THR-instructeur.
De groep zal een bereden activiteit van 45 minuten ondernemen om horsemanship-vaardigheden te leren, zoals beschreven in de THR-handleiding van de studie.
De groepstijden zijn tussen 13.00 en 17.00 uur om speekselcortisol te verzamelen.
Wekelijks zullen de deelnemers een consistente routine volgen waarbij ze zowel hun elektrodermale activiteits- als hartslagmeters dragen, vóór de les aan een groepskunsttafel gaan zitten. Hierna zal het studiepersoneel de deelnemers instrueren om het 10 cm lange schuimstaafje onder hun tong te plaatsen voor één minuut terwijl u naar een timer van 1 minuut kijkt.
Vervolgens zetten de deelnemers hun rijhelm op en betreden ze de rijbak.
Elke week na afloop van de THR-interventie gaan de deelnemers opnieuw 5 minuten met hun groep aan een kunsttafel zitten, gevolgd door nog een speekselmonster.
|
Paard therapie
Andere namen:
|
|
Actieve vergelijker: Schuur activiteit
Deze Arm is een kleine groep van 10 weken van één uur (2-4 deelnemers) onder leiding van een THR-instructeur en mede geleid door een aanbieder van geestelijke gezondheidszorg of ergotherapie.
Deelnemers krijgen één vrijwilliger toegewezen en hebben geen fysiek contact met paarden op de manege, ze kunnen alleen paarden van een afstand bekijken.
Er zal een levensgroot knuffelpaard aanwezig zijn voor praktijkgericht leren gerelateerd aan het wekelijkse onderwerp volgens de BA-studiehandleiding.
De groepstijden zijn tussen 13.00 en 17.00 uur om speekselcortisol te verzamelen.
Wekelijks zullen de deelnemers een consistente routine volgen waarbij ze zowel hun elektrodermale activiteits- als hartslagmeters dragen, vóór de les aan een groepskunsttafel gaan zitten. Hierna zal het studiepersoneel de deelnemers instrueren om het 10 cm lange schuimstaafje onder hun tong te plaatsen voor één minuut terwijl u naar een timer van 1 minuut kijkt.
Elke week na afloop van de BA-interventie gaan de deelnemers opnieuw 5 minuten met hun groep aan een kunsttafel zitten, gevolgd door nog een speekselmonster.
|
Horsemanship groep
Andere namen:
|
|
Experimenteel: Hybride
Deelnemers die de wachtlijst-arm- en post-assessments voltooien, beginnen tussen 13.00 en 17.00 uur aan een hybride groep.
De groep bestaat uit een kleine BA-groep van 5 weken en 1 uur (2-4 deelnemers) onder leiding van een THR-instructeur en mede onder leiding van een geestelijke gezondheidszorgadviseur of OT.
Deelnemers krijgen één vaste vrijwilliger toegewezen en hebben geen fysiek contact met paarden op de manege, ze bekijken alleen paarden op afstand.
Er zal een levensgroot knuffelpaard zijn voor praktische, wekelijkse onderwerpen volgens de BA-studiehandleiding.
Groep.
Vervolgens voltooien de deelnemers een kleine groep Therapeutisch Paardrijden van 5 weken (2-4 deelnemers) onder leiding van een THR-instructeur.
De groep omvat een activiteit te paard van 45 minuten om paard: rijden te leren, gevolgd door een activiteit van 15 minuten voor het verzorgen en overstag gaan van niet-gemonteerde paarden volgens de THR-handleiding.
Deelnemers krijgen een toegewezen paard en vrijwilliger(s).
|
Grond- en rijactiviteiten
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Aberrant Behavior Checklist-Community (ABC-C) - Baseline
Tijdsspanne: Baseline
|
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
|
Baseline
|
|
Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
Tijdsspanne: End of Treatment
|
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
|
End of Treatment
|
|
Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
Tijdsspanne: 6 months post intervention
|
The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
|
6 months post intervention
|
|
Social Responsiveness Scale™, Second Edition - End of Treatment
Tijdsspanne: End of Treatment
|
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
|
End of Treatment
|
|
Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
Tijdsspanne: 6 months post intervention
|
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
|
6 months post intervention
|
|
Emotion Dysregulation Inventory (EDI) - Baseline
Tijdsspanne: Baseline
|
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
|
Baseline
|
|
Emotion Dysregulation Inventory (EDI) - End of Treatment
Tijdsspanne: End of Treatment
|
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
|
End of Treatment
|
|
Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
Tijdsspanne: 6 months post intervention
|
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
|
6 months post intervention
|
|
Systematic Analysis of Language Transcripts (SALT) - Baseline
Tijdsspanne: Baseline
|
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
|
Baseline
|
|
Systematic Analysis of Language Transcripts (SALT) - End of Treatment
Tijdsspanne: End of Treatment
|
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
|
End of Treatment
|
|
Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
Tijdsspanne: 6 months post treatment
|
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
|
6 months post treatment
|
|
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
Tijdsspanne: Baseline
|
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
|
Baseline
|
|
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
Tijdsspanne: End of Treatment
|
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
|
End of Treatment
|
|
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
Tijdsspanne: 6 months post intervention
|
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
|
6 months post intervention
|
|
Social Responsiveness Scale™, Second Edition - Baseline
Tijdsspanne: Baseline
|
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors).
NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES.
The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES.
The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES.
The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
HIGHER SCORES ON THIS SUBSCALE.
|
Baseline
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Salivary Cortisol - Baseline Baseline
Tijdsspanne: Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
|
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed separately.
|
Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
|
|
Salivary Cortisol - Mid-Point
Tijdsspanne: Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
|
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
|
Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
|
|
Salivary Cortisol - End of Treatment
Tijdsspanne: Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
|
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
|
Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
|
|
Heart Rate Variability - Baseline
Tijdsspanne: Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
|
The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
|
Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
|
|
Heart Rate Variability - Mid-point
Tijdsspanne: Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
|
The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
|
Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
|
|
Heart Rate Variability - End of Treatment
Tijdsspanne: Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
|
The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
|
Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
|
|
Electrodermal Activity -- Baseline
Tijdsspanne: Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
|
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured during the intervention lesson.
Unit of measure is microsiemens.
|
Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
|
|
Electrodermal Activity - Mid-point
Tijdsspanne: Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
|
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
|
Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
|
|
Electrodermal Activity - End of Treatment
Tijdsspanne: Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
|
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
|
Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 december 2020
Primaire voltooiing (Werkelijk)
22 februari 2025
Studie voltooiing (Werkelijk)
22 februari 2025
Studieregistratiedata
Eerst ingediend
15 oktober 2020
Eerst ingediend dat voldeed aan de QC-criteria
22 oktober 2020
Eerst geplaatst (Werkelijk)
28 oktober 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
24 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 19-1962
- 1R01HD097693-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .