High Intensity Training for Patients with Anxiety

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Anxiety; Depression Anxiety Disorder; Blood Pressure Check (Hypertension Screening)
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

The study is a randomised controlled trial ("RCT") design with a 1:1 allocation into two groups. The two groups are high intensity exercise (1x4 minutes performed two times per week with a heart rate above 85% of maximal heart rate) and low intensity exercise (45 minutes performed two times per week with a heart rate of approximately 60% of maximal heart rate). The total amount of training sessions for both groups will be eight. The high intensity exercise group will serve as the intervention group, while the low intensity exercise group will serve as an active control group.

The patients will be randomly allocated (randomised) to these groups. An exercise physiologist (holding a master's degree in exercise physiology) will supervise the training sessions. The training sessions will take place in a dedicated room using a treadmill and a heart rate monitor. The training sessions will be individual.

The primary outcome measure will be degree of anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS) and Beck Naxiety Inventory (BAI) prior to the first (pre) and after the last (post) training session is completed. Secondary outcome measures will be compliance, i.e. to what degree the patient is able to sustain the exercise regimen three months after participating in the project, in addition to the patient's blood pressure.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tromsø, Norway, 9015
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity exercise training	Behavioral: Exercise; The investigators will investigate the differences between high and low intensity training
Active Comparator: Low intensity exercise training	Behavioral: Exercise; The investigators will investigate the differences between high and low intensity training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic and diastolic blood pressure	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 is a questionnaire for detecting depressive symptoms. This questionnaire range from 0 to 63. Lower scores mean a better outcome.	Beck Depression Inventory will be performed on the first day the patient attends the study and on the very last day the patient attends.

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: University of Tromso

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: mental health; physical exercise; high intensity training
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 714458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No