Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders
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: Intervention group/training group.
- Кому может быть актуально
- Состояния в реестре: Severe Mental Disorder. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Digital Follow-up of Exercise Training in Outpatients With Mental Disorders
Обзор
This randomized-controlled trial (RCT) will investigate if digital follow-up of exercise, i.e. followup through the new citizen portal HelsaMi, coupled with an exercise app can result in exercise adherence and improved oxygen uptake in individuals with mental disorders (MD). Secondary, the project will provide information regarding effects on cardiovascular disease risk-factors, functional capacity, quality of life, satisfaction, and cost through a randomized-controlled trial (RCT) including individuals with MDs. Outcomes assessed in this project, such as maximal oxygen uptake, functional capacity, and quality of life, are strongly related to the ability to carry out activities of daily living. These outcomes are associated with benefits such as reduced sick leave, extended life expectancy, independence, and improved health status with increasing age. Economically, with the world population growing older and health care resources being stretched, there is clearly a need to apply and evaluate effective alternative methods to improve somatic health on a broader scale in a sustainable fashion, preferably utilizing existing platforms and exercise apps.
Подробное описание
The main aim of this randomized controlled trial (RCT) is to investigate if digital exercise followup can support exercise adherence and result in increased aerobic capacity in individuals with MDs. We will assess the short-term effects through a 12-week intervention, and its long-term effects after 1-year. Both the intervention group (IG) and control group (CG) will receive two sessions of aerobic interval training at the Exercise Training Clinic, situated at the Department of Psychosis and Rehabilitation, Psychiatry Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. One training session consists of 36 minutes of high intensity training (HIT). HIT consists of 4x4 intervals on a treadmill at 85-95% of maximal heart rate, interspersed by 3minute active rest periods at 70% maximal heart rate \[31\]. Following the educational exercise sessions at the Exercise Training Clinic, the IG will be encouraged to perform two aerobic interval training sessions per week for 12 weeks, on their own and not at the exercise training clinic, while receiving digital follow-up support through HelsaMi and exercise guidance through the exercise app. The digital follow-up through HelsaMi will consist of overview of treatment progress and schedule, communication with health care personnel (video consultation or chat up to 2 times per week), notifications reminding them to exercise, exercise diary, questionnaires, and educational content.
Objective. To investigate if digital exercise follow-up through HelsaMi combined with an exercise app (Myworkout GO) in individuals with MDs is more effective at improving exercise adherence and aerobic capacity compared to standard treatment coupled with advice on how to perform high intensity interval training without any digital follow-up.
Main hypothesis. Digital follow-up of exercise yields better results than only being advised to exercise at improving exercise adherence, peak oxygen uptake (V̇ O2peak), work efficiency, functional capacity, and quality of life after 12 weeks and 1-year.
Вмешательства
- Другое Intervention group/training group
We will assess the short-term effects through a 12-week intervention, and its long-term effects after 1-year. Both the intervention group (IG) and control group (CG) will receive two sessions of aerobic interval training at the Exercise Training Clinic, situated at the Department of Psychosis and Rehabilitation, Psychiatry Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. One training session consists of 36 minutes of high intensity training (HIT).
Первичные конечные точки
- Peak oxygen uptake [Срок оценки: Baseline, 12 weeks, 1 year]
Вторичные конечные точки (12)
- Physical activity measurement [Срок оценки: 1-2 weeks]
- Use of health care services [Срок оценки: Baseline, 12 weeks, 1 year]
- Usage data of HelsaMi [Срок оценки: Baseline, 12 weeks, 1 year]
- Functional performance/capacity [Срок оценки: Baseline, 12 weeks, 1 year]
- Feasibility - Drop-out/retention [Срок оценки: 12 weeks, 1 year]
- Changes in walking economy [Срок оценки: Baseline, 12 weeks, 1 year]
- Motivation to Exercise: Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) [Срок оценки: Baseline, 12 weeks, 1 year]
- Health Literacy: eHealth Literacy Scale (eHEALS) [Срок оценки: Baseline, 12 weeks, 1 year]
- Mental Health-Related Barriers and Benefits to Exercise: MEX [Срок оценки: Baseline, 12 weeks, 1 year]
- Potential Barriers and Enablers Reported: System Usability Scale (SUS) [Срок оценки: Baseline, 12 weeks, 1 year]
- Patient satisfaction (questionnaires) [Срок оценки: Baseline, 12 weeks, 1 year]
- Patient activation [Срок оценки: Baseline, 12 weeks, 1 year]
Критерии участия
Критерии включения
- Individuals receiving outpatient mental health treatment at the clinics of mental health at St. Olavs Hospital,.
.-18-65 years old
- Both men and women able to carry out exercise training.
- Participants must be capable of giving informed consent and use HelsaMi.
Критерии исключения
- Contraindications for exercise training and testing according to the ACSM specifications; life-threatening or terminal medical conditions; unable to carry out intervention or test procedures; pregnancy; mothers \<6 months post-partum.
- Inpatients at an acute psychiatric ward or have any planned surgery that would interfere with the intervention.
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
- St. Olavs Hospital HF. And NTNU (Norwegian University of Science and Technology) Departmen — Trondheim
Идентификаторы
NCT: NCT06628011 · 633068