NCT03247270

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

3.9 years

First QC Date

August 4, 2017

Last Update Submit

August 2, 2021

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (22)

  • Anxiety symptom burden

    Established psychiatric self-assessment scales: BAI

    12 weeks after baseline

  • Anxiety symptom burden

    Established psychiatric self-assessment scales: BAI

    1 year after baseline

  • Anxiety symptom burden

    Established psychiatric self-assessment scales: MADRS-S

    12 weeks after baseline

  • Anxiety symptom burden

    Established psychiatric self-assessment scales: MADRS-S

    1 year after baseline

  • Anxiety symptom burden

    Established psychiatric self-assessment scales: EQ-5D

    12 weeks after baseline

  • Anxiety symptom burden

    Established psychiatric self-assessment scales: EQ-5D

    1 year after baseline

  • Cognitive ability

    Test Design Fluency, which is part of the D-Kefs battery of tests

    12 weeks after baseline

  • Cognitive ability

    Test Design Fluency, which is part of the D-Kefs battery of tests

    1 year after baseline

  • Cognitive ability

    Digit test included in WAIS test battery

    12 weeks after baseline

  • Cognitive ability

    Digit test included in WAIS test battery

    1 year after baseline

  • Sick leave

    Questionnaire

    12 weeks after baseline

  • Sick leave

    Questionnaire

    1 year after baseline

  • Biomarkers in serum

    S-IGF-I

    12 weeks after baseline

  • Biomarkers in serum

    S-IGF-I

    1 year after baseline

  • Biomarkers in serum

    S-BDNF

    12 weeks after baseline

  • Biomarkers in serum

    S-BDNF

    1 year after baseline

  • Biomarkers in serum

    S-VEGF

    12 weeks after baseline

  • Biomarkers in serum

    S-VEGF

    1 year after baseline

  • Biomarkers in serum

    S-high sensitivity CRP

    12 weeks after baseline

  • Biomarkers in serum

    S-high sensitivity CRP

    1 year after baseline

  • Biomarkers in serum

    S-irisin

    12 weeks after baseline

  • Biomarkers in serum

    S-irisin

    1 year after baseline

Study Arms (3)

Intervention I

EXPERIMENTAL

Physical exercise intervention: 12 week exercise program with low-intensity fitness training 3 times per week.

Behavioral: Intervention I

Intervention II

EXPERIMENTAL

Physical exercise intervention:12 week exercise program with moderate to high-intensity fitness training 3 times per week

Behavioral: Intervention II

Control group

NO INTERVENTION

Control group, who will have a physiotherapy session once and will be given general advice about physical activity.

Interventions

Intervention IBEHAVIORAL

Low intensive physical exercise

Intervention I
Intervention IIBEHAVIORAL

High intensive physical exercise

Intervention II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Panic syndrome (F41.0)
  • Generalized anxiety (F41.1)
  • Mixed anxiety- and depression conditions (F41.2 and F41.3)
  • Anxiety UNS (F41.9)

You may not qualify if:

  • Physical difficulties in performing a physical exercise program
  • Pathological ECG
  • Previous psychiatric illnesses
  • Ongoing abuse
  • Increased risk of suicide as determined by the GP
  • Pregnant women
  • Physical activity level at baseline exceeding one exercise occasion per week.
  • Ongoing psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health and Community Medicine

Gothenburg, Sweden

Location

Related Publications (19)

  • Love J, Hensing G, Soderberg M, Toren K, Waern M, Aberg M. Future marginalisation and mortality in young Swedish men with non-psychotic psychiatric disorders and the resilience effect of cognitive ability: a prospective, population-based study. BMJ Open. 2016 Aug 10;6(8):e010769. doi: 10.1136/bmjopen-2015-010769.

    PMID: 27515748BACKGROUND

  • Hillman CH, Erickson KI, Kramer AF. Be smart, exercise your heart: exercise effects on brain and cognition. Nat Rev Neurosci. 2008 Jan;9(1):58-65. doi: 10.1038/nrn2298.

    PMID: 18094706BACKGROUND

  • Aberg MA, Aberg ND, Palmer TD, Alborn AM, Carlsson-Skwirut C, Bang P, Rosengren LE, Olsson T, Gage FH, Eriksson PS. IGF-I has a direct proliferative effect in adult hippocampal progenitor cells. Mol Cell Neurosci. 2003 Sep;24(1):23-40. doi: 10.1016/s1044-7431(03)00082-4.

    PMID: 14550766BACKGROUND

  • Carro E, Nunez A, Busiguina S, Torres-Aleman I. Circulating insulin-like growth factor I mediates effects of exercise on the brain. J Neurosci. 2000 Apr 15;20(8):2926-33. doi: 10.1523/JNEUROSCI.20-08-02926.2000.

    PMID: 10751445BACKGROUND

  • Lee TMC, Wong ML, Lau BW, Lee JC, Yau SY, So KF. Aerobic exercise interacts with neurotrophic factors to predict cognitive functioning in adolescents. Psychoneuroendocrinology. 2014 Jan;39:214-224. doi: 10.1016/j.psyneuen.2013.09.019. Epub 2013 Sep 25.

    PMID: 24149089BACKGROUND

  • Eliakim A, Oh Y, Cooper DM. Effect of single wrist exercise on fibroblast growth factor-2, insulin-like growth factor, and growth hormone. Am J Physiol Regul Integr Comp Physiol. 2000 Aug;279(2):R548-53. doi: 10.1152/ajpregu.2000.279.2.R548.

    PMID: 10938244BACKGROUND

  • Kohut ML, McCann DA, Russell DW, Konopka DN, Cunnick JE, Franke WD, Castillo MC, Reighard AE, Vanderah E. Aerobic exercise, but not flexibility/resistance exercise, reduces serum IL-18, CRP, and IL-6 independent of beta-blockers, BMI, and psychosocial factors in older adults. Brain Behav Immun. 2006 May;20(3):201-9. doi: 10.1016/j.bbi.2005.12.002. Epub 2006 Feb 28.

    PMID: 16504463BACKGROUND

  • Stranahan AM, Martin B, Maudsley S. Anti-inflammatory effects of physical activity in relationship to improved cognitive status in humans and mouse models of Alzheimer's disease. Curr Alzheimer Res. 2012 Jan;9(1):86-92. doi: 10.2174/156720512799015019.

    PMID: 22329653BACKGROUND

  • Aberg MA, Waern M, Nyberg J, Pedersen NL, Bergh Y, Aberg ND, Nilsson M, Kuhn HG, Toren K. Cardiovascular fitness in males at age 18 and risk of serious depression in adulthood: Swedish prospective population-based study. Br J Psychiatry. 2012 Nov;201(5):352-9. doi: 10.1192/bjp.bp.111.103416. Epub 2012 Jun 14.

    PMID: 22700083BACKGROUND

  • Aberg MA, Nyberg J, Toren K, Sorberg A, Kuhn HG, Waern M. Cardiovascular fitness in early adulthood and future suicidal behaviour in men followed for up to 42 years. Psychol Med. 2014 Mar;44(4):779-88. doi: 10.1017/S0033291713001207. Epub 2013 Jun 6.

    PMID: 23739044BACKGROUND

  • Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.

    PMID: 24026850BACKGROUND

  • Danielsson L, Papoulias I, Petersson EL, Carlsson J, Waern M. Exercise or basic body awareness therapy as add-on treatment for major depression: a controlled study. J Affect Disord. 2014 Oct;168:98-106. doi: 10.1016/j.jad.2014.06.049. Epub 2014 Jul 5.

    PMID: 25043321BACKGROUND

  • Stubbs B, Vancampfort D, Rosenbaum S, Firth J, Cosco T, Veronese N, Salum GA, Schuch FB. An examination of the anxiolytic effects of exercise for people with anxiety and stress-related disorders: A meta-analysis. Psychiatry Res. 2017 Mar;249:102-108. doi: 10.1016/j.psychres.2016.12.020. Epub 2017 Jan 6.

    PMID: 28088704BACKGROUND

  • Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

    PMID: 3204199BACKGROUND

  • Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.

    PMID: 444788BACKGROUND

  • Homack S, Lee D, Riccio CA. Test review: Delis-Kaplan executive function system. J Clin Exp Neuropsychol. 2005 Jul;27(5):599-609. doi: 10.1080/13803390490918444.

    PMID: 16019636BACKGROUND

  • Åstrand P-O et al., (2003). Textbook of work physiology: physiological bases of exercise. Champaign:Human Kinetics.

    BACKGROUND

  • Drummond M et al., (2015). Methods for the economic evaluation of health care programmes. Oxford, United Kingdom, Oxford University Press.

    BACKGROUND

  • Nyberg J, Henriksson M, Aberg ND, Wall A, Eggertsen R, Westerlund M, Danielsson L, Kuhn HG, Waern M, Aberg M. Effects of exercise on symptoms of anxiety, cognitive ability and sick leave in patients with anxiety disorders in primary care: study protocol for PHYSBI, a randomized controlled trial. BMC Psychiatry. 2019 Jun 10;19(1):172. doi: 10.1186/s12888-019-2169-5.

    PMID: 31182054DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ulf Nilsson, PhD

    Göteborg University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 11, 2017

Study Start

August 21, 2017

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Locations

SE(1)