NCT06881758

Brief Summary

The aim of the current project is to examine the effects of high intensity exercise (by using 1x4 intervals) to reduce symptoms of anxiety in patients in mental health care. The expected benefits for patients are positive health effects, by improving physical fitness and reducing psychological symptom burden. The patients will have the opportunity to learn to use physical activity as a specific measure to be used in their own lives and be a source of coping. Furthermore, knowledge about physical activity and mental health may be applicable in mental health care as a part of a treatment plan.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
20mo left

Started Apr 2025

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress39%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

December 13, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

December 13, 2024

Last Update Submit

March 11, 2025

Conditions

Keywords

physical exercisemental healthhigh intensity training

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    Hospital Anxiety and Depression Scale (HADS). This a questionnaire generating a scale ranging from 0 to 42 points. Lower scores mean a better outcome.

    HADS will be performed on the first day the patient attends the study and on the very last day the patient attends.

Secondary Outcomes (2)

  • Systolic and diastolic blood pressure

    We will measure the blood pressure on the first day the patient attends the study and on the very last day the patient attends.

  • Beck Depression Inventory

    Beck Depression Inventory will be performed on the first day the patient attends the study and on the very last day the patient attends.

Study Arms (2)

High intensity exercise training

EXPERIMENTAL

High intensity exercise training

Behavioral: Exercise

Low intensity exercise training

ACTIVE COMPARATOR

Low intensity exercise training

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

The investigators will investigate the differences between high and low intensity training

High intensity exercise trainingLow intensity exercise training

Eligibility Criteria

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

You may qualify if:

  • Patients with mild/moderate anxiety disorders, aged 18-60 years. Anxiety disorders in accordance with F 41 in ICD-10, including generalised anxiety disorder, agoraphobia/panic disorder, social phobia, post-traumatic stress disorder, hypochondria, and obsessive-compulsive disorder.
  • Comorbidity will occur, so the patient may also have depression. However, the main disorder should be anxiety.

You may not qualify if:

  • Somatic diseases that may impede training: cardiovascular disease, severe asthma, severe COPD, cancer, poorly regulated diabetes.
  • Schizophrenia or bipolar disease
  • Suicidality (prior attempts or ongoing risk of suicide)
  • Substance addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9015, Norway

Location

Related Publications (1)

  • Bystad M, Rydland S, Bugge C, Hogmo S, Brondbo B, Jacobsen R, Garcia-Fernandez L, Rodriguez-Jimenez R, Romero-Ferreiro V, Wynn R. High-intensity training vs. low-intensity training for patients with anxiety: a randomised controlled trial. Trials. 2026 Jan 27. doi: 10.1186/s13063-026-09472-2. Online ahead of print.

MeSH Terms

Conditions

Anxiety DisordersMotor ActivityPsychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental DisordersBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research

Study Record Dates

First Submitted

December 13, 2024

First Posted

March 18, 2025

Study Start

April 15, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to various reasons, including concerns about patient privacy and confidentiality, legal or ethical restrictions, the potential risk of re-identifying participants, and the protection of sensitive data.

Locations