NDLI: Exercise training complementary to specialised early intervention in patients with first-episode psychosis: a feasibility randomised trial

Content Provider	Springer Nature : BioMed Central
Author	Midtgaard, Julie Schnor, Helle Bjerre, Eik D. Jespersen, Tobias Jelsøe, Nina Frølund, Nanna Seier, Søren Rønbøg, Jacob W. Nordsborg, Nikolai B. Ebdrup, Bjørn H.
Abstract	Background The aim of this study was to examine feasibility of trial processes and group-based, structured exercise training in patients with first-episode psychosis. Methods Twenty-five patients with first-episode psychosis took part in a two-arm randomised feasibility trial. They were individually randomised (1:1) via a computer-generated randomisation sequence and allocated to either an exercise intervention group (INT) or a control group (CON). Patients allocated to INT completed a physical exercise training programme at moderate-to-vigorous intensity, 1 h three times weekly for 8 weeks. CON patients were encouraged to continue their usual level of activity and were offered the training programme after 8 weeks. Primary outcomes included screening rate, recruitment rate, retention rate, attendance and adverse events. Secondary outcomes included heart rate response during training, cardiovascular health (VO2max, resting heart rate, blood pressure), body composition (muscle mass, fat percentage), muscle strength (sit-to-stand, grip strength, jump height) and balance. Results Recruitment lasted 6 weeks and 86 out of 324 patients (27%) were screened, 71 of whom (83%) were deemed eligible. Twenty-five (35%) accepted inclusion (mean age 25.5; mean body mass index 25.1) and were subsequently randomised (INT = 13, CON = 12). Retention of patients was 76% and 52% at the 8-week and 16-week follow-up, respectively. Attendance was 43% (min. 9%, max. 96%). No significant changes were observed between groups in secondary physiological outcome measures. Conclusions Feasibility was challenged by limited recruitment and retention rates, suggesting that modifications are required if a large-scale randomised controlled trial is to be conducted. Recommendations for modifications are presented and discussed. Trial registration Clinicaltrials.gov, NCT03409393 . Retrospectively registered.
Related Links	https://pilotfeasibilitystudies.biomedcentral.com/counter/pdf/10.1186/s40814-021-00900-5.pdf
Ending Page	11
Page Count	11
Starting Page	1
File Format	HTM / HTML
ISSN	20555784
DOI	10.1186/s40814-021-00900-5
Journal	Pilot and Feasibility Studies
Issue Number	1
Volume Number	7
Language	English
Publisher	BioMed Central
Publisher Date	2021-08-19
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Exercise training Feasibility First-episode psychosis Randomised trial Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine
Journal Impact Factor	1.5/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
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7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
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9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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