Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000482965
Ethics application status
Approved
Date submitted
13/04/2020
Date registered
17/04/2020
Date last updated
17/04/2020
Date data sharing statement initially provided
17/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of high intensity interval training and aerobic training on stress, depression symptoms, anxiety and resilience in self-isolated people during the COVID-19 health emergency in Spain
Scientific title
Impact of high intensity interval training and aerobic training in on stress, depression symptoms, anxiety and resilience in self-isolated people during the COVID-19 health emergency in Spain: a randomized controlled trial.
Secondary ID [1] 301000 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 317040 0
Anxiety 317077 0
Depression 317078 0
Condition category
Condition code
Mental Health 315202 315202 0 0
Anxiety
Mental Health 315203 315203 0 0
Depression
Mental Health 315245 315245 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A home-based intervention based on high-intensity interval training (HIIT). A physical therapist, with more than 5 years of experience, will provide a video session upload to YouTube. A WhatsApp message will individually send to each participant with a session link, that they will have to complete.
Frequency, duration of the sessions and overall duration of the intervention: 45 min of HIIT session, six days per week during all the self-isolation period (6 weeks estimated).
Each session will have:
1) A warm-up (10 min): Joint mobility exercises.
2) Main part: CORE, arms and legs exercises, with 10-12 sets of 30-90 seconds with 15-60 seconds of rest between sets (ie. push ups, squats, splits or dead lifts). All the exercises will be performed with their own weight.
3) Cold down: Flexibility exercises.
Adherences will daily be monitored through WhatsApp message.
Intervention code [1] 317321 0
Prevention
Comparator / control treatment
A home-based intervention based on aerobic training will be the control intervention. A physical therapist, with more than 5 years of experience, will provide a video session upload to YouTube. A WhatsApp message will individually send to each participant with a session link, that they will have to complete.
Frequency, duration of the sessions and overall duration of the intervention: 45 min of aerobic session, six days per week during all the self-isolation period (6 weeks estimated).
Each session will have:
1) A warm-up (10 min): Joint mobility exercises.
2) Main part: 3-4 sets of 6-8 minutes with 1-2 minutes of rest between sets (ie. boxing squats, jumping jacks, skipping or skaters). All the exercises will be performed with their own weight.
3) Cold down: Flexibility exercises.
Adherences will daily be monitored through WhatsApp message.
Control group
Active

Outcomes
Primary outcome [1] 323461 0
Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Timepoint [1] 323461 0
Baseline (after the first exercise session), after three weeks of exercise intervention and after the self-isolation period (approximately 6 weeks after intervention commencement).
Primary outcome [2] 323462 0
Depression symptoms by the the Beck Depression Inventory (BDI-13)
Timepoint [2] 323462 0
Baseline (after the first exercise session), after three weeks of exercise intervention and after the self-isolation period (approximately 6 weeks after intervention commencement)..
Primary outcome [3] 323463 0
Stress by the Perceived Stress Scale (PPS-10)
Timepoint [3] 323463 0
Baseline (after the first exercise session), after three weeks of exercise intervention and after the self-isolation period (approximately 6 weeks after intervention commencement)..
Secondary outcome [1] 382007 0
Resilience by the Connor-Davidson (CD-RISC) scale.
Timepoint [1] 382007 0
Baseline (after the first exercise session), after three weeks of exercise intervention and after the self-isolation period (approximately 6 weeks after intervention commencement)..

Eligibility
Key inclusion criteria
a) Be self-isolated as a consequence of the legal restrictions caused by the COVID-19 health emergency.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Participate in other physical activity intervention during the self-isolation.
b) Have the COVID-19.
c) Have a musculoskeletal injury.
d) Be under anxiety, depression, or stress treatment.
c) Have any health disorder or patology where physical activity is contraindicated.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The State-Trait Anxiety Inventory (STAI) was employed in order to estimate the sample size using the PASS software. Taking into account the data from a previous research (Mailey et al., 2010), A total of 34 participants ( 17 subjects per group) were estimated in order to detect differences (a value 0.05 and 99% of power) in a repeated measures design.

Emily L. Mailey , Thomas R. Wójcicki , Robert W. Motl , Liang Hu , David R. Strauser , Kimberly D. Collins & Edward McAuley (2010) Internet-delivered physical activity intervention for college students with mental health disorders: A randomized pilot trial, Psychology, Health & Medicine, 15:6, 646-659

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
17/03/2020
Date of last participant enrolment
Anticipated
Actual
18/03/2020
Date of last data collection
Anticipated
26/04/2020
Actual
Sample size
Target
34
Accrual to date
Final
77
Recruitment outside Australia
Country [1] 22490 0
Spain
State/province [1] 22490 0

Funding & Sponsors
Funding source category [1] 305444 0
University
Name [1] 305444 0
University of Extremadura
Country [1] 305444 0
Spain
Primary sponsor type
Individual
Name
Juan P. Fuentes-García
Address
Av. Universidad s/n (10003)
Facultad de Ciencias del Deporte, Cáceres, Spain
Country
Spain
Secondary sponsor category [1] 305843 0
Individual
Name [1] 305843 0
Santos Villafaina
Address [1] 305843 0
Av. Universidad s/n (10003)
Facultad de Ciencias del Deporte, Cáceres, Spain
Country [1] 305843 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305761 0
University of Extremadura research ethics committee
Ethics committee address [1] 305761 0
Ethics committee country [1] 305761 0
Spain
Date submitted for ethics approval [1] 305761 0
14/03/2020
Approval date [1] 305761 0
16/03/2020
Ethics approval number [1] 305761 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101502 0
Dr Juan Pedro Fuente-García
Address 101502 0
Av. Universidad s/n (10003)
Facultad de Ciencias del Deporte, Cáceres, Spain
Country 101502 0
Spain
Phone 101502 0
+34927257460
Fax 101502 0
Email 101502 0
jpfuent@unex.es
Contact person for public queries
Name 101503 0
Santos Villafaina
Address 101503 0
Av. Universidad s/n (10003)
Facultad de Ciencias del Deporte, Cáceres, Spain
Country 101503 0
Spain
Phone 101503 0
+34927257460
Fax 101503 0
Email 101503 0
svillafaina@unex.es
Contact person for scientific queries
Name 101504 0
Santos Villafaina
Address 101504 0
Av. Universidad s/n (10003)
Facultad de Ciencias del Deporte, Cáceres, Spain
Country 101504 0
Spain
Phone 101504 0
+34927257460
Fax 101504 0
Email 101504 0
svillafaina@unex.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims in the approved proposal as well as for IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator
(Juan Pedro Fuentes-García, Av. Universidad s/n (10003), Cáceres, Spain; jpfuent@unex.es)


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.