High Intensity Training for Patients with Anxiety
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tromsø, Norway, 9015
- University Hospital of North Norway
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: High intensity exercise training
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The investigators will investigate the differences between high and low intensity training
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Active Comparator: Low intensity exercise training
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The investigators will investigate the differences between high and low intensity training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: HADS will be performed on the first day the patient attends the study and on the very last day the patient attends.
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Hospital Anxiety and Depression Scale (HADS).
This a questionnaire generating a scale ranging from 0 to 42 points.
Lower scores mean a better outcome.
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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
Time Frame: We will measure the blood pressure on the first day the patient attends the study and on the very last day the patient attends.
|
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.
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Beck Depression Inventory
Time Frame: Beck Depression Inventory will be performed on the first day the patient attends the study and on the very last day the patient attends.
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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
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 714458
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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