Effects of an Interdisciplinary Fitness and Social Engagement Intervention (InFuSe)
31. august 2018 opdateret af: Washington D.C. Veterans Affairs Medical Center
Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI).
Primary outcomes include physical activity (PA), sleep quality, and community integration.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This randomized controlled trial will have a sample size of 24.
Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited.
After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise.
The intervention will occur weekly and last up to 2 hours.
The control group will complete a 10week comprehensive health education program simultaneously.
All measures will be collected again, post intervention.
A follow-up collection will occur at 3 months post-intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20422
- Washington DC VA Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- TBI of at least mild severity using criteria related to disturbance of consciousness
- Most recent TBI occurred >1 year prior to consent process
- Medically stable with physician approval to participate
Exclusion Criteria:
- Unable to provide informed consent and no proxy available
- Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
- Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
- Veteran is currently active in a skilled physical therapy program.
- Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: InFuSE
Experimental group which will receive health education, group discussion, and supervised exercise.
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Each session includes a 45-minute education and group discussion.
A 60-minute exercise component then completes the session.
Each topic was specifically picked and tailored to benefit Veterans with TBI.
The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities.
The activities are included to help improve understanding and promote group discussion.
The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
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Aktiv komparator: Patient Education/Group Discussion
Active control group which will receive health education and group discussion.
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Each week you will participate in a 1 hour health education class with other Veterans.
Each topic was specifically picked and tailored for Veterans with TBI.
These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Exercise Self-Efficacy Scale (ESES)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sleep Efficiency
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed.
Sleep efficiency is measured by polysomnography.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Capacity
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Functional capacity is evaluated using a Bruce protocol treadmill maximal exertion stress test.
The maximum amount of work performed by the participant on the treadmill is measured as metabolic equivalents (METs)
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Dynamic Gait Index (DGI)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure to evaluate and monitor overall sleep quality.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Mayo Portland Adaptability Index (MPAI-4)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of self-reported quality of life, limitation severity, and community participation after TBI.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Community Reintegration of Service Members (CRIS)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure of the ability of service members to reintegrate after returning to civilian life.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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California Verbal Learning Test-Second Edition (CVLT-II)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A widely used measure of verbal learning and memory using a multiple-trial list-learning task.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Brief Symptoms Inventory 18 (BSI-18)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-report measure of depression, anxiety, somatic concerns, and general distress.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Post-Traumatic Stress Disorder Checklist (PCL)
Tidsramme: Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2016
Primær færdiggørelse (Forventet)
1. december 2018
Studieafslutning (Forventet)
1. december 2018
Datoer for studieregistrering
Først indsendt
28. marts 2017
Først indsendt, der opfyldte QC-kriterier
17. maj 2017
Først opslået (Faktiske)
19. maj 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01798
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med InFuSE
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Gruppo Italiano per lo studio dei Carcinomi dell...Mario Negri Institute for Pharmacological ResearchUkendt