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Physical Exercise for Treatment of Depression and Anxiety - RCT (FYPO)

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ClinicalTrials.gov Identifier: NCT04714528
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
Örebro University, Sweden
Uppsala University
Karolinska Institutet
Information provided by (Responsible Party):
Yvonne Freund-Levi, Region Örebro County

Study Description
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Brief Summary:
In a 12 week randomly controlled open trial 102 participants with symptoms of depression and/or anxiety will be exposed to either aerobic high intensity training (HIT) or relaxation therapy. Cognitive functions, biomarkers, psychiatric symptom scales and physical status will be collected at baseline, after 12 weeks and after a year. Depression and anxiety will be measured twice during the intervention period.

Condition or disease Intervention/treatment Phase
Depression Anxiety Other: Physical Exercise Other: Relaxation Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Physical Exercise Group
45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.
 Other: Physical Exercise
Physical exercise as described before.
Relaxation Group
45 minutes of relaxation therapy once per week for 12 weeks.
 Other: Relaxation Therapy
Relaxation therapy as described before.


Outcome Measures
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Primary Outcome Measures :
  1. Symptom improvement in depression [ Time Frame: Change of the score from the baseline to the score at 12 weeks. ]
    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale (MADRS). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.

  2. Symptom improvement in depression [ Time Frame: Change of the score from the baseline to the score at 1 year. ]
    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale (MADRS). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.

  3. Symptom improvement in anxiety [ Time Frame: Change of the score from the baseline to the score at 12 weeks. ]
    Improvement of symptom severity grade are assessed with Beck Anxiety Inventory (BAI). The minimum and the maximum score is 0 and 63 respectively, and the higher score means a worse outcome.

  4. Symptom improvement in anxiety [ Time Frame: Change of the score from the baseline to the score at 1 year. ]
    Improvement of symptom severity grade are assessed with Beck Anxiety Inventory (BAI). The minimum and the maximum score is 0 and 63 respectively, and the higher score means a worse outcome.

  5. Subjective symptom improvement in depression [ Time Frame: Change of the score from the baseline to the score at 12 weeks. ]
    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale Self-Rating Version (MADRS-S). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.

  6. Subjective symptom improvement in depression [ Time Frame: Change of the score from the baseline to the score at 1 year. ]
    Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale Self-Rating Version (MADRS-S). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.


Secondary Outcome Measures :
  1. Cognitive function: Trail Making Test Part A&B [ Time Frame: Comparison of results between baseline and week 12. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  2. Cognitive function: Trail Making Test Part A&B [ Time Frame: Comparison of results between baseline and year 1. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  3. Cognitive function: Symbol Digit Modalities Test [ Time Frame: Comparison of results between baseline and week 12. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  4. Cognitive function: Symbol Digit Modalities Test [ Time Frame: Comparison of results between baseline and year 1. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  5. Cognitive function: Corsi Block-Tapping Test forward [ Time Frame: Comparison of results between baseline and week 12. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  6. Cognitive function: Corsi Block-Tapping Test forward [ Time Frame: Comparison of results between baseline and year 1. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  7. Cognitive function: Rey Auditory Verbal Learning Test [ Time Frame: Comparison of results between baseline and week 12. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  8. Cognitive function: Rey Auditory Verbal Learning Test [ Time Frame: Comparison of results between baseline and year 1. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  9. Cognitive function: Stroop test [ Time Frame: Comparison of results between baseline and week 12. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  10. Cognitive function: Stroop test [ Time Frame: Comparison of results between baseline and year 1. ]
    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  11. Investigation of gut biomarkers [ Time Frame: Up to 1 year from baseline. ]
    The fecal samples will be analyzed for biomarkers of microbial composition, inflammation and gut barrier function using 16S microbiota analysis, metabolomics and Next Generation Sequencing.

  12. Investigation of inflammatory biomarkers [ Time Frame: Up to 1 year from baseline. ]
    The inflammatory biomarkers will be analyzed using ELISA and Luminex.

  13. Investigation of fatty acid profiles [ Time Frame: Up to 1 year from baseline. ]
    A fatty acid profile in the serum or plasma will be analyzed using gas chromatography coupled to mass spectrometry.


Other Outcome Measures:
  1. Clinical Global Impression (CGI) severity scale [ Time Frame: Up to 1 year from baseline. ]
    Clinician's impression of total severity of the mental illness. Scale between 0 and 7, higher point indicates worse outcome.

  2. Posttraumatic Stress Disorder Checklist (PCL-5) [ Time Frame: Up to 1 year from baseline. ]
    Measures symptoms in posttraumatic stress disorder. Total points 0-80, higher point indicates worse outcome.

  3. Adult ADHD Self-Report Scale (ASRS) [ Time Frame: Up to 1 year from baseline. ]
    Measures symptoms in attention deficiency and hyperactivity disorder (ADHD). Higher point indicates worse outcome.

  4. Perceived Stress Scale (PSS-14) [ Time Frame: Up to 1 year from baseline. ]
    Measures perceived stress. Higher point indicates worse outcome.

  5. EuroQol-Health-Related Quality of Life (EQ-5D-5L) [ Time Frame: Up to 1 year from baseline. ]
    Assesses the current overall health related to wellbeing and function experienced by the patient.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Score ≥12 on MADRS or score ≥16 on BAI
  • Inhabitant i Örebro County, Sweden
  • BMI ≥18 kg/m^2

Exclusion Criteria:

  • Diagnosis of chronic psychotic disease or ongoing psychotic episode.
  • Ongoing manic state of bipolar disorder
  • Severe somatic disease or condition where high intensity exercise is contraindicated
  • Difficulty with reading, hearing or understanding the Swedish language
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714528


Contacts
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Contact: Yvonne Freund-Levi, MD, PhD +46 736841130 yvonne.freund@oru.se
Contact: Qiwei Zhai, MD +46 790631305 qiwei.zhai@regionorebrolan.se

Locations
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Sweden
Department of Psychiatry, University hospital Örebro Recruiting
Örebro, Sweden
Contact: Yvonne Freund-Levi, MD, PhD    +46 736841130    yvonne.freund@oru.se   
Contact: Qiwei Zhai, MD    +46 790631305    qiwei.zhai@regionorebrolan.se   
Sponsors and Collaborators
Region Örebro County
Örebro University, Sweden
Uppsala University
Karolinska Institutet
Investigators
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Principal Investigator: Yvonne Freund-Levi, MD, PhD Region Örebro County/Örebro University
More Information
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Publications:

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Responsible Party: Yvonne Freund-Levi, Associate Professor, M.D., Ph.D, Region Örebro County
ClinicalTrials.gov Identifier: NCT04714528    
Other Study ID Numbers: 273723
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yvonne Freund-Levi, Region Örebro County:
Post Traumatic Stress Disorder
Attention Deficit Hyperactivity Disorder
Exercise
Bipolar disorder
Cognitive functions
Biomarkers
Fatty acids
 Cytokines
Neurotrophins
Accelerometer
Microbiota
Metabolomics
Lipidomics
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
 Behavioral Symptoms
Mood Disorders
Mental Disorders