Trial document




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  DRKS00021273

Trial Description

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Title

Effects of digital home exercise programs on physical and mental well-being during the COVID-19 pandemic: a multi-center trial

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Trial Acronym

ASAP: Activity and health during the SARS-CoV2 pandemic

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URL of the Trial

http://asap-study.mystrikingly.com

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Brief Summary in Lay Language

The outbreak of the novel coronavirus has changed a lot within a very short time. In many countries, public life has been restricted (e.g. by closing shops, contact bans or curfews) in order to reduce human contact and slow down the spread of the virus. This also means that access to fitness studios, sports clubs or sports facilities is no longer possible.

Against this background, our study aims to examine the effectiveness of a digital home exercise program with respect to mental and physical well-being and physical activity levels.

The study has total duration of 8 weeks.

In the first four weeks, participants are assigned to a training group or a control group.
Participants in the intervention group participate in a live, video-based home exercise program. Participants who are assigned to the control group will not receive training.

Following the initial 4-week period, participants of both groups will be given access to an online archive with various workout videos for another 4 weeks, which they can use as often as they wish.

In order to test the effectiveness of the training programs, a questionnaire is answered prior to and following as well as weekly during the interventions (approx. 5 to 10 minutes). Here, we ask for basic information (such as gender and age), mental and physical well-being, sleep as well as the frequency of training during the intervention periods.

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Brief Summary in Scientific Language

Abundant evidence supports the value of physical activity (PA) and exercise as essential cornerstones of physical and mental health (Arem et al., 2015; Fishman et al., 2016; White et al., 2017). Since the outbreak of the novel coronavirus (SARS-CoV-2) in December 2019, the opportunities to engage in sport and exercise have changed drastically in many countries (Chen et al., 2020). Due to governmental regulations restricting public life (e.g. bans of public gatherings, business closures or city lockdowns; Wang et al., 2020), the ability to move freely has been reduced for the general population. The resulting limits in access to sports clubs, gyms and self-organized outdoor activities are assumed to result in a considerable decrease in global and individual PA levels (Chen et al., 2020).

Our study, therefore, aims to investigate the feasibility of digital home-exercise programs as well as their effectiveness in increasing physical and mental health.

A total of 544 healthy participants will be recruited in several countries and randomly allocated to an intervention and control group. The intervention group will receive a 4-week home-based digital exercise program, while the control group does not exercise. After this period, both groups will have a 4-week access to an online database with digital workouts which can be freely used.

Before the first intervention period, after two and 4 weeks (end of first intervention) as well as after 8 weeks (end of second intervention period), physical activity levels and mental/physical well-being is assessed using online questionnaires.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

-

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Organizational Data

  •   DRKS00021273
  •   2020/04/20
  •   [---]*
  •   yes
  •   Approved
  •   2020-25, Ethikkommission des Fachbereichs für Psychologie und Sportwissenschaften der Goethe-Universität Frankfurt
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Fitness training in healthy individuals
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Interventions/Observational Groups

  •   Home-based exercise training

    Participants in the intervention group receive a 4-week, digital (video livestream) home exercise program. In each country various course with different durations and contents (e.g. strength or endurance training, balance training or relaxation exercises) will be offered. They can be freely used.

    After the 4 weeks, the participants have another 4-week access to a digital archive containing pre-recorded exercise sesisons.
  •   inactive wait-control group

    The members of the wait-control group do not exercise during the initial 4 weeks.

    After the 4 weeks, the participants have a 4-week access to a digital archive containing pre-recorded exercise sesisons.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Physical and mental well-being assessed with questionnaire battery

- Nordic Physical Activity Questionnaire, short-form
- WHO5-questionniare
- Graded Chronic Pain Scale
- MOS sleep scale
- Generalized Anxiety Scale 7

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Secondary Outcome

Frequency of use of digital training interventions

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Countries of Recruitment

  •   Germany
  •   Argentina
  •   South Africa
  •   Austria
  •   Italy
  •   Spain
  •   Chile
  •   Brazil
  •   Ireland
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/04/25
  •   544
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age of 18 or older
- voluntary consent for study participation
- unrestricted sporting ability (Physical Activity Readiness Questionnaire)

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Exclusion Criteria

- severe cardiovascular, neurological, metabolic and psychiatric diseases
- recommendation of a physician not to engage in physical activity or medical advice not to be physically active to full degree
- simultaneous participation in other studies

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Addresses

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    • Goethe-Universität Frankfurt Institut für Sportwissenschaften Abteilung Sportmedizin
    • Mr.  Dr.  Jan  Wilke 
    • Ginnheimer Landstr. 39
    • 60487  Frankfurt am Main
    • Germany
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    • Universidade Cidade de São Paulo - UNICID
    • Mr.  Prof.   Luiz   Hespanhol 
    • R. Cesário Galero, 448
    • 03071-000  Sao Paulo
    • Brazil
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    • University of Graz
    • Ms.  Prof.  Mireille  van Poppel 
    • Mozartgasse 14/I
    • 8010  Graz
    • Austria
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    • Fundación Instituto Superior de Ciencias de la Salud
    • Mr.  Fernando  Laino 
    • Yerbal 1885
    • 02138  Buenos Aires
    • Argentina
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    • Università degli Studi di Roma "Foro Italico"
    • Ms.  Dr  Chiara  Fossati 
    • P.zza Lauro de Bosis 15
    • 00135  Rom
    • Italy
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    • Universidad de Cádiz
    • Mr.  Prof  David  Jiménez-Pavón 
    • Centro Cultural Reina Sofía C/ Paseo Carlos III, nº 9
    • 11003  Cádiz
    • Spain
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    • Waterford Insitute of Technology
    • Mr.  Dr  Niamh  Murphy 
    • Cork Rd
    • X91 K0EK  Waterford
    • Ireland
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    • DUT Durban
    • Mr.  Prof  Julian David  Pillay 
    • 41/43 M L Sultan Rd
    • 4001  Durban
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    • Goethe-Universität Frankfurt
    • Mr.  Dr.  Jan  Wilke 
    • Ginnheimer Landstr. 39
    • 60488  Frankfurt
    • Germany
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    • Goethe-Universität Frankfurt
    • Mr.  Dr.  Jan  Wilke 
    • Ginnheimer Landstr. 39
    • 60488  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Goethe-Universität Frankfurt Institut für Sportwissenschaften Abteilung Sportmedizin
    • Mr.  Dr.  Jan  Wilke 
    • Ginnheimer Landstraße 39
    • 60488  Frankfurt am Main
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.