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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

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE January 19, 2021
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Investigation of inflammatory biomarkers [ Time Frame: Up to 1 year from baseline. ]
    The inflammatory biomarkers will be analyzed using ELISA and Luminex.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 15, 2021)
  • 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.
  • 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.
  • 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.
  • Perceived Stress Scale (PSS-14) [ Time Frame: Up to 1 year from baseline. ]
    Measures perceived stress. Higher point indicates worse outcome.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Physical Exercise for Treatment of Depression and Anxiety - RCT
Official Title  ICMJE Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Anxiety
Intervention  ICMJE
  • Other: Physical Exercise
    Physical exercise as described before.
  • Other: Relaxation Therapy
    Relaxation therapy as described before.
Study Arms  ICMJE
  • Active Comparator: Physical Exercise Group
    45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.
    Intervention: Other: Physical Exercise
  • Relaxation Group
    45 minutes of relaxation therapy once per week for 12 weeks.
    Intervention: Other: Relaxation Therapy
Publications * Björngrim S, van den Hurk W, Betancort M, Machado A, Lindau M. Comparing Traditional and Digitized Cognitive Tests Used in Standard Clinical Evaluation - A Study of the Digital Application Minnemera. Front Psychol. 2019 Oct 18;10:2327. doi: 10.3389/fpsyg.2019.02327. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2021)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yvonne Freund-Levi, MD, PhD +46 736841130 yvonne.freund@oru.se
Contact: Qiwei Zhai, MD +46 790631305 qiwei.zhai@regionorebrolan.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04714528
Other Study ID Numbers  ICMJE 273723
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yvonne Freund-Levi, Region Örebro County
Study Sponsor  ICMJE Region Örebro County
Collaborators  ICMJE
  • Örebro University, Sweden
  • Uppsala University
  • Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Yvonne Freund-Levi, MD, PhD Region Örebro County/Örebro University
PRS Account Region Örebro County
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP