High Intensity Training for Patients with Anxiety

NCT ID: NCT06881758

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Anxiety; Depression Anxiety Disorder; Blood Pressure Check (Hypertension Screening)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High intensity exercise training

High intensity exercise training

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Low intensity exercise training

Low intensity exercise training

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tromso

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Martin Kragnes Bystad

Head of research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

Other Identifiers

714458

Identifier Type: -

Identifier Source: org_study_id