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MemoryNCT03143582

Examining the Effects of a Team-based Running Program

A study testing Running in people with Memory and Learning, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators are interested in finding accessible interventions for youth and young adults that help promote long-term positive mental health functioning. They will be investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on mental health symptoms, memory, and attention. Read more about this study

Who is it for?
Ages 17 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Memory, Learning, Mood
What is being tested?
Running
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
31 Jan 2017to 30 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy enough to participate in physical activity

Who cannot join

  • NOT excluded on basis of mental health or addiction concerns

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Youth Wellness Centre

    Hamilton, Ontario, L8P 4W6

Other trials in Canada

About this study

Official title: Examining the Effects of a Team-based Running Program on the Mental Health and Cognition of Emerging Adults: A Pilot Study

The investigators are interested in finding accessible interventions for youth and young adults that help promote long-term positive mental health functioning. They will be investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on mental health symptoms, memory, and attention. This intervention will hopefully improve mental health functioning in youth aged 17-25 that are at high risk of developing mental health disorders. Sessions will consist of 30 minutes of running under the supervision of group leaders and coaches. The group will steadily increase the distance and time spent running versus walking, with the goal of having everyone run a 5 km race together at the end of 13 weeks. Once a week, youth will be provided with education on a variety of topics related to health and running. Youth will complete measures before, during, and after the program to assess outcomes.

Being tested
Running

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RunningOther

    Also called Exercise

    A 13-week running program where youth run for 30 minutes twice weekly.

Study groups in NCT03143582
Study groupRoleWhat they receive
Running groupExperimental13 week, bi-weekly running group
Receives: Other: Running

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire 9 (PHQ-9)

    Nine-item self-report measure designed to monitor the severity of depressive symptoms using the diagnostic criteria found in the DSM-IV

    Measured: Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.

  2. Generalized Anxiety Disorder 7 (GAD-7)

    Seven-item self-report anxiety questionnaire designed to monitor and assess the severity of generalized anxiety disorder (GAD) symptoms, using the prominent diagnostic features found in the DSM-IV

    Measured: Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.

  3. Kessler Psychological Distress Scale (K-10)

    Ten-item self-report measure of global psychological distress

    Measured: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.

Secondary outcomes (11)

  1. PTSD Checklist for DSM-V (PCL-5)

    Twenty-item self-report measure of PTSD based on the DSM-V diagnostic criteria

    Measured: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.

  2. Rosenberg Self-Esteem Scale (RSES)

    Ten-item self-report measure of global feelings of self-worth

    Measured: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.

  3. Multidimensional Scale of Perceived Social Support

    Twelve-item self-report measure of perceived support from three sources: Family, friends, and a significant other

    Measured: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.

  4. Work and Social Adjustment Scale (WSAS)

    Five-item self-report measure of impairment in functioning

    Measured: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.

  5. Physical Activity and Sleep

    Participants will use a Fitbit to monitor their overall activity (e.g., steps, distance, active minutes, etc.) and sleep patterns before, during, and after treatment

    Measured: Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.

  6. Delis-Kramer Executive Function Tower Task

    Assesses spatial planning, rule learning, and response inhibition

    Measured: At baseline and 1-week after exercise program ends.

  7. Hopkins Verbal Learning Task

    Tests participants' memory for a list of 12 nouns drawn from 3 categories, and measures immediate and delayed recall and recognition

    Measured: At baseline and 1-week after exercise program ends.

  8. N-back

    A test of executive function (working memory), requiring the participant to observe a sequence of items and click on targets that are repeats n items ago

    Measured: At baseline and 1-week after exercise program ends.

  9. Concentration Memory Task

    A test of high interference spatial memory. Participants search for pairs of matching cards and are periodically tested on which of two locations an item appeared in most recently

    Measured: At baseline and 1-week after running program ends.

  10. Town Square

    A test of viewpoint-dependent and -independent spatial memory for a set of visually presented items in a town square

    Measured: At baseline and 1-week after running program ends.

  11. Wechsler Test of Adult Reading

    A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study start31 Jan 2017
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label pilot study examining the effects of exercise on mood, learning, memory, attention, stress, and sleeping habits.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03143582
Sponsor's protocol ID
2785
Status last verified
Apr 2020
First submitted
28 Apr 2017
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • RiskAnalytica. The life and economic impact of major mental illnesses in canada. Mental Health Commission of Canada. 2011:2011-2041.

  • Lim KL, Jacobs P, Ohinmaa A, Schopflocher D, Dewa CS. A new population-based measure of the economic burden of mental illness in Canada. Chronic Dis Can. 2008;28(3):92-8.

    PubMed 18341763

  • Merikangas KR, Nakamura EF, Kessler RC. Epidemiology of mental disorders in children and adolescents. Dialogues Clin Neurosci. 2009;11(1):7-20. doi: 10.31887/DCNS.2009.11.1/krmerikangas.

    PubMed 19432384

  • Shapiro CM, Bortz R, Mitchell D, Bartel P, Jooste P. Slow-wave sleep: a recovery period after exercise. Science. 1981 Dec 11;214(4526):1253-4. doi: 10.1126/science.7302594.

    PubMed 7302594

  • Dery N, Pilgrim M, Gibala M, Gillen J, Wojtowicz JM, Macqueen G, Becker S. Adult hippocampal neurogenesis reduces memory interference in humans: opposing effects of aerobic exercise and depression. Front Neurosci. 2013 Apr 30;7:66. doi: 10.3389/fnins.2013.00066. eCollection 2013.

    PubMed 23641193

  • Anderson RJ, Brice S. The mood-enhancing benefits of exercise: Memory biases augment the effect. Psychology of Sport & Exercise. 2011;12(2):79-82. doi: 10.1016/j.psychsport.2010.08.003.

  • van Oers HM. Exercise effects on mood in breast cancer patients. South African Journal of Sports Medicine. 2013;25(2):55. doi: 10.7196/SAJSM.481.

  • Prakash RS, Voss MW, Erickson KI, Lewis JM, Chaddock L, Malkowski E, Alves H, Kim J, Szabo A, White SM, Wojcicki TR, Klamm EL, McAuley E, Kramer AF. Cardiorespiratory fitness and attentional control in the aging brain. Front Hum Neurosci. 2011 Jan 14;4:229. doi: 10.3389/fnhum.2010.00229. eCollection 2011.

    PubMed 21267428

  • Chang YK, Pesce C, Chiang YT, Kuo CY, Fong DY. Antecedent acute cycling exercise affects attention control: an ERP study using attention network test. Front Hum Neurosci. 2015 Apr 9;9:156. doi: 10.3389/fnhum.2015.00156. eCollection 2015.

    PubMed 25914634

  • Monti JM, Hillman CH, Cohen NJ. Aerobic fitness enhances relational memory in preadolescent children: the FITKids randomized control trial. Hippocampus. 2012 Sep;22(9):1876-82. doi: 10.1002/hipo.22023. Epub 2012 Apr 23.

    PubMed 22522428

  • Quelhas Martins A, Kavussanu M, Willoughby A, Ring C. Moderate intensity exercise facilitates working memory. Psychology of Sport and Exercise. 2013;14(3):323-328. doi: 10.1016/j.psychsport.2012.11.010

  • Guiney H, Machado L. Benefits of regular aerobic exercise for executive functioning in healthy populations. Psychon Bull Rev. 2013 Feb;20(1):73-86. doi: 10.3758/s13423-012-0345-4.

    PubMed 23229442

  • Snyder JS, Soumier A, Brewer M, Pickel J, Cameron HA. Adult hippocampal neurogenesis buffers stress responses and depressive behaviour. Nature. 2011 Aug 3;476(7361):458-61. doi: 10.1038/nature10287.

    PubMed 21814201

  • van Praag H, Shubert T, Zhao C, Gage FH. Exercise enhances learning and hippocampal neurogenesis in aged mice. J Neurosci. 2005 Sep 21;25(38):8680-5. doi: 10.1523/JNEUROSCI.1731-05.2005.

    PubMed 16177036

  • Hutton CP, Dery N, Rosa E, Lemon JA, Rollo CD, Boreham DR, Fahnestock M, deCatanzaro D, Wojtowicz JM, Becker S. Synergistic effects of diet and exercise on hippocampal function in chronically stressed mice. Neuroscience. 2015 Nov 12;308:180-93. doi: 10.1016/j.neuroscience.2015.09.005. Epub 2015 Sep 7.

    PubMed 26358368

Questions about this trial

What is this clinical trial studying?

A study testing Running in people with Memory and Learning, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire 9 (PHQ-9) (time frame: Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03143582, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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