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Physical Fitness and Brain - Interventional Study

NCT03247270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-08-03

No results posted yet for this study

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.

Conditions

  • Anxiety Disorders

Interventions

BEHAVIORAL

Intervention I

Low intensive physical exercise

BEHAVIORAL

Intervention II

High intensive physical exercise

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Ulf Nilsson, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247270 on ClinicalTrials.gov