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Технико-экономическое обоснование использования физических упражнений в качестве начальной стратегии лечения RTMS при трудно поддающейся лечению депрессии

28 сентября 2026 г. обновлено: Sara Tremblay, The Royal Ottawa Mental Health Centre

Рандомизированное исследование по оценке возможности физических упражнений в качестве начальной стратегии лечения RTMS при трудно поддающейся лечению депрессии

The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise). These findings will be used to inform future large-scale projects in which we will investigate, in a larger sample size, whether structured exercise aimed to improve fitness as recommended by most public exercise guidelines (i.e., ≥3x/week, moderate-to-vigorous intensity) serves as an active ingredient that amplifies the effectiveness of iTBS. Ultimately, the insights gained from this study will be valuable for clinicians seeking to alleviate depressive symptoms in MDD through neuromodulation techniques such as iTBS.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

This is a randomized, two-arm, pilot feasibility clinical trial design involving physically inactive individuals diagnosed with treatment-resistant depression (TRD). Participants will be randomly assigned to either: 1) 4-weeks of exercise (moderate-to-vigorous intensity; ~1h session, 3x/week) followed by 6 weeks of iTBS combined with exercise (intervention group), or 2) 4 weeks of stable treatment (i.e. no change in psychotropic medication/psychotherapy regimen or physical activity) followed by 6 weeks of iTBS alone (control group). The intervention group is divided into two phases: the priming phase and the synergetic phase. Due to the neuroplasticity-enhancing effects of exercise and fitness, and based on pilot results demonstrating superior antidepressant effects of TBS in physically active participants, the main objective of the priming phase is to enhance brain plasticity mechanisms through increases in fitness from the 4 weeks of exercise training. In other words, this phase aims to build capacity for a better response to TBS treatment. The synergetic phase (interventional group) follows the priming and involves integrating TBS treatment into the exercise training regimen. Participants in the interventional group will maintain their exercise routine to enhance and sustain gains while undergoing TBS treatment for 6 weeks. In accordance with the recommended guidelines for both exercise and TBS treatment for depression, participants in the interventional group will engage in exercise sessions lasting approximately 1 hour, three times per week. In both interventional and control groups, TBS treatment will be administered five times per week, with treatment delivery lasting 3 minutes. We hypothesize that all aspects of this project will be feasible, that is the exercise and iTBS delivery and outcomes assessment. Additionally, we expect participants to show high levels of adherence and compliance with the strategy. The ultimate goal, to be investigated in a larger-scale study following this one, is to determine whether exercise acts as an active ingredient that enhances the effectiveness of iTBS.

Тип исследования

Интервенционный

Регистрация (Оцененный)

20

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Stacey Shim, MSc
  • Номер телефона: 6356 613-722-6521
  • Электронная почта: stacey.shim@theroyal.ca

Учебное резервное копирование контактов

  • Имя: Emma Cummings, BSc
  • Номер телефона: 6586 6137226521
  • Электронная почта: emma.cummings@theroyal.ca

Места учебы

  • Канада
    • Ontario
      • Ottawa, Ontario, Канада, k1z 7k4
        • Рекрутинг
        • Royal Ottawa Mental Health Centre
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Are between 18-75 years old.
  2. Able to provide voluntary informed consent.
  3. Diagnosis of MDD or Persistent Depressive Disorder, without psychotic features, confirmed by MINI for DSM-5.
  4. Depressive symptoms have not improved after ≥ 1 adequate antidepressant trial in the current episode (i.e., difficult-to-treat MDD), based on the Antidepressant Treatment History Form (ATHF).
  5. Baseline score of ≥15 on the HRSD-17.
  6. No change in psychotropic medications or psychotherapy regimen at least 4 weeks prior to entering the trial
  7. Physically inactive as per the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
  8. Able to engage in structured exercise as per the Get Active Questionnaire (GAQ).
  9. Able to adhere to the proposed treatment schedule.

Exclusion Criteria:

  1. Diagnosis of bipolar I or II disorder, based on DSM-5 criteria.
  2. Current or past (<3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria.
  3. Current use of illegal substances.
  4. Current use of cannabis.
  5. Concomitant major unstable medical or neurologic illness (e.g., uncontrolled diabetes or renal dysfunction).
  6. Organic cause of the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician.
  7. Acute suicidality or threat to life from self-neglect.
  8. Pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment.
  9. Contraindication for TMS and MRI (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker), confirmed by TMS Adult Safety Scale (TASS) and MRI pre-screener.
  10. Unwilling to maintain current psychotropic medication and/or psychotherapy regimen for the four weeks prior to and for the duration of the study.
  11. Taking more than 1 mg/day of lorazepam or equivalent.
  12. Any other condition that, in the opinion of the investigators which would adversely affect the participant's ability to complete the study.
  13. Physically active: performing exercise and/or physical activity levels meeting the cut-off for "minimally active" on the IPAQ-SF.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Intervention Group

4-weeks of exercise (moderate-to-vigorous intensity) followed by 6 weeks of iTBS combined with exercise.
Устройство: Theta burst stimulation

Cool B70 cooled-coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)

Другие имена:
  • рТМС
Другой: Standard Group

Standard care of 4 weeks of stable treatment (i.e. no changes to antidepressant regimen or physical activity) followed by 6 weeks of iTBS alone.
Устройство: Theta burst stimulation

Cool B70 cooled-coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)

Другие имена:
  • рТМС

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Assessing feasibility on combining structured exercise and intermittent Theta Burst Stimulation (iTBS) in participants with treatment-resistant depression (TRD)
Временное ограничение: Assessed at the end of the study once all participants have completed the study.

Feasibility outcomes are crucial metrics that will guide the refinement of our protocols, thereby enhancing our preparedness for future design endeavors. These will include: 1) recruitment, 2) adherence, 3) compliance, 4) retention, 5) satisfaction, and 6) adverse events.
Assessed at the end of the study once all participants have completed the study.
Compare the effects on clinical response of exercise on enhancing iTBS treatment efficacy vs. iTBS alone
Временное ограничение: Administered at screening, before iTBS treatment course (week 4), at the end of the treatment course (week 10), then at the 6-week follow-up (week 16)

Clinical response will be defined as a ≥ 50% reduction in the 17-item Grid Hamilton Rating Scale for Depression (Grid-HRSD-17). The Grid HRSD is a clinician-rated instrument with seventeen items used to measure the severity of depressive episodes. The overall score ranges from 0 to 52, where scores of 0 to 7 are considered as being normal, 8 to 16 suggest mild depression, 17 to 23 moderate depression, and scores ≥ 24 indicate severe depression.
Administered at screening, before iTBS treatment course (week 4), at the end of the treatment course (week 10), then at the 6-week follow-up (week 16)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in self-reported depression symptoms as measured by Beck Depression Inventory (BDI-II).
Временное ограничение: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)

As a secondary measure of depressive symptoms. Score scale from 0 (better outcome, no depression) to 63 (worst outcome, extreme depression).
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in self-reported anxiety symptoms as measured by Beck Anxiety Inventory (BAI)
Временное ограничение: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)

As a secondary measure of anxiety symptoms. Score scale from 0 (better outcome, no depression) to 63 (worst outcome, extreme anxiety).
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in self-reported suicidal thoughts symptoms as measured by Beck Scale for Suicidal Ideation (BSS)
Временное ограничение: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)

To assess the effect of treatment on suicidal thoughts that may be improved by iTBS.

Score scale from 0 (better outcome, no desire for suicide) to 38 (worst outcome, extreme desire for suicide).
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in self-reported hopelessness as measured by State Hope Scale (SHS)
Временное ограничение: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)

To assess the effect of treatment on self-report symptoms and perceptions of stress that may be improved by iTBS.

6-item measure where responses are rated on an 8-point Likert scale. Score scale from 1 (Definitely True) to 8 (Definitely False).
Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in neuroplasticity as measured by neurophysiology (TMS) and MRI (Arterial Spin Labelling measures of brain blood flow)
Временное ограничение: Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10)

To assess the effect of treatment on biomarkers. Greater improvements in these biomarkers will also be associated with greater reductions in depressive symptoms.
Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10)
Change in grip strength as measured by dynamometer
Временное ограничение: Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10), and at 6-week follow-up assessment (week 16)

To assess the effect of treatment on biomarkers. Greater improvements in these biomarkers will also be associated with greater reductions in depressive symptoms.
Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10), and at 6-week follow-up assessment (week 16)
Change in physical measures as assessed by anthropometrics
Временное ограничение: Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10), and at 6-week follow-up assessment (week 16)

To assess the effect of the intervention on physical health.
Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10), and at 6-week follow-up assessment (week 16)

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Incidence of Treatment-Emergent Adverse Events
Временное ограничение: Daily Monday-Friday throughout study (16 weeks).

Adverse events will be tracked and recorded.
Daily Monday-Friday throughout study (16 weeks).
Side Effects
Временное ограничение: Daily Monday-Friday throughout study (16 weeks).

Side effects will be tracked and recorded on any TMS visits, using the TMS side effects questionnaire.
Daily Monday-Friday throughout study (16 weeks).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

The Royal Ottawa Mental Health Centre

Соавторы

University of Ottawa

Следователи

  • Главный следователь: Sara Tremblay, PhD, Royal Ottawa Mental Health Centre

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 марта 2026 г.

Первичное завершение (Оцененный)

31 января 2027 г.

Завершение исследования (Оцененный)

31 января 2027 г.

Даты регистрации исследования

Первый отправленный

8 января 2025 г.

Впервые представлено, что соответствует критериям контроля качества

8 января 2025 г.

Первый опубликованный (Действительный)

14 января 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 0227

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

All Individual Participant Data collected from this study (IPD) will be de-identified for all parties who have permission to access it. This de-identified data may be shared with other researchers at the Royal's Institute of Mental Health Research. De-identified may be shared with the public only upon request. Please note that all data that has the potential of revealing participants' identity will NOT be used to share.

Сроки обмена IPD

De-identified data may become available (upon request) when the study is completed and published (anticipated time frame: the year of 2027)

Критерии совместного доступа к IPD

De-identified data will be accessible only through the permission of the lead research scientist. All requests must be made and accepted by her.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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