CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 168 enrolled
Drug / intervention
Intervention I +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03247270
NCT03247270N/ACompleted

Physical Fitness and Brain - Interventional Study of the Importance of Physical Fitness on Symptoms of Anxiety, Cognitive Ability and Sick Leave, in Primary Care.

Göteborg University·interventional·Posted Aug 11, 2017·Updated Aug 3, 2021

In Brief

A clinical study evaluating Intervention I and Intervention II for Anxiety Disorders. Completed, enrolled 168 participants across 1 site.

Detailed Summary

According to the Global Burden of Disease report in 2015, anxiety disorders are among the top 10 contributors to years lived with disability worldwide. There is a need for effective treatment protocols. As cardiovascular fitness has a major impact on the brain's ability to change structurally and functionally, interventions involving physical exercise might prove positive in the treatment of persons with anxiety. Yet there are few high quality clinical studies with physical exercise as an intervention for anxiety disorders. Aims: 1. To test a 12 week physical exercise intervention for persons treated for anxiety disorders within primary care. The exposure of interest is intensity of physical exercise; outcomes include anxiety symptom burden, cognitive ability and sick leave. 2. To gain knowledge regarding potential mechanisms by comparing serum levels of specific hormones and cytokines (characterized and associated with brain plasticity in animal models) before and after different intensities of exercise. Implementation: Patients will be randomized into 3 groups: 1) Intervention I: 12 week exercise program with low-intensity fitness training 3 times per week. 2) Intervention II: 12 week exercise program with moderate to high-intensity fitness training 3 times per week. 3) Control group, who will have a physiotherapy session once and will be given general advice about physical activity. At baseline, 12 weeks and 1 year data of cardiovascular fitness, anxiety symptoms, cognitive and working ability and biomarkers will be collected. Impact: If physical exercise positively affects anxiety disorders it would have significance, for the patients as well as for society. In addition to increased quality of life, it may decrease future marginalization and premature death among individuals suffering from anxiety disorders. Reducing medical and sick-leave costs would also liberate health care resources to be used elsewhere in an economically strained health care system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 11, 2017
Enrollment StartAug 21, 2017
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.9 years ago

Interventions

Intervention Ibehavioral

Low intensive physical exercise

Intervention IIbehavioral

High intensive physical exercise