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Набор по приглашению NCT06881758

High Intensity Training for Patients with Anxiety

Без фазы С лечением Anxiety Depression Anxiety Disorder Blood Pressure Check (Hypertension Screening)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Exercise.
Кому может быть актуально
Состояния в реестре: Anxiety, Depression Anxiety Disorder, Blood Pressure Check (Hypertension Screening). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Anxiety [Срок оценки: HADS will be performed on the first day the patient attends the study and on the very last day the patient attends.]
Вторичные конечные точки (2)
  • Systolic and diastolic blood pressure [Срок оценки: 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 [Срок оценки: Beck Depression Inventory will be performed on the first day the patient attends the study and on the very last day the patient attends.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • University Hospital of North Norway — Tromsø

Публикации

  • 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;27(1):153. doi: 10.1186/s13063-026-09472-2. PMID 41593737

Идентификаторы

NCT: NCT06881758 · 714458

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗