Physical Exercise for Treatment of Depression and Anxiety - RCT

NCT ID: NCT04714528

Last Updated: 2024-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical Exercise Group

45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.

Group Type ACTIVE_COMPARATOR

Physical Exercise

Intervention Type OTHER

Physical exercise as described before.

Relaxation Group

45 minutes of relaxation therapy once per week for 12 weeks.

Group Type OTHER

Relaxation Therapy

Intervention Type OTHER

Relaxation therapy as described before.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Exercise

Physical exercise as described before.

Intervention Type OTHER

Relaxation Therapy

Relaxation therapy as described before.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Örebro University, Sweden

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yvonne Freund-Levi

Associate Professor, M.D., Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yvonne Freund-Levi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Örebro County/Örebro University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry, University hospital Örebro

Örebro, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Bjorngrim 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.

Reference Type BACKGROUND
PMID: 31681117 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

273723

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise for Anxiety
NCT04638946 ACTIVE_NOT_RECRUITING NA
Exercise and Inflammation
NCT01335737 COMPLETED NA