Physical Activity Intervention for Older Family Carers (CAREFIT)
11 июня 2026 г. обновлено: Jenni Kulmala, Tampere University
Supporting Physical Activity and Functional Capacity Among Older Family Caregivers (CAREFIT): A Six-month, Randomised Controlled Pilot Trial
The goal of this pilot trial is to learn whether a six-month physical activity program tailored for older family caregivers can be successfully delivered and whether participants are willing and able to take part in it. The study will also explore possible effects of the programme on physical activity, physical function, health, and well-being.
The main questions it aims to answer are:
- Can enough participants be recruited to the study?
- Do participants adhere to the study and complete follow-up assessments?
- How often do participants take part in the program activities?
- How acceptable and useful do participants find the program?
- What are the possible effects of the programme on physical activity, health, and wellbeing.
Researchers will compare the physical activity program with a control group that receives health information and education about healthy ageing.
Participants will:
- Complete health, physical functioning, and questionnaire assessments at the beginning of the study, after 6 months, and after 12 months
- Wear an activity monitor on their wrist for 7 days and nights at the beginning of the study and after 6 months
- Will be randomly assigned to either a six-month physical activity program designed for older family caregivers, or a control group that receives health information and education about healthy ageing.
- If assigned to the physical activity program, participants will take part in weekly group-based and remote exercise sessions for 6 months.
- Provide feedback about their experiences of the program
Обзор исследования
Статус
Еще не набирают
Подробное описание
Family caregivers provide substantial support to older adults living at home. Many caregivers are themselves older adults and may experience challenges in maintaining their own health and well-being while providing care. Caregiving responsibilities may limit opportunities for physical activity due to time constraints, competing demands, and the need to remain available for the care recipient. Despite the potential benefits of physical activity for maintaining physical function, mental well-being, and overall health, relatively little is known about how to design and deliver physical activity interventions that are feasible and acceptable for older family caregivers.
The CAREFIT study is a randomized controlled pilot trial designed to evaluate the feasibility and acceptability of a physical activity intervention tailored for older family caregivers. The study will provide information on recruitment, retention, adherence, and participant acceptability to support the planning of a future larger-scale trial. The study will also explore potential effects of the intervention on physical activity, physical functioning, motivation, stress, well-being, caregiving experience, cognitive function, and other health-related outcomes.
Participants are randomly allocated in a 1:1 ratio to either an intervention group or a control group. The intervention group receives a six-month multi-component physical activity programme specifically designed for older family caregivers. The programme combines supervised group-based exercise sessions with remotely delivered sessions to increase accessibility and accommodate caregiving responsibilities. Exercise activities focus on strength, balance, functional exercise, and light-to-moderate intensity aerobic activity and are adapted to participants' functional abilities. Participants also receive individualized goal-setting and motivational support at the beginning of the programme. In addition, the intervention includes brief guided relaxation exercises and education on themes related to healthy ageing, recovery, musculoskeletal health, and well-being.
The control group receives health education, including general information on healthy lifestyle behaviors and educational material related to healthy ageing and brain health, but does not participate in the structured physical activity programme during the intervention period.
Outcome assessments are conducted at baseline, after the six-month intervention period, and at a twelve-month follow-up. Post-intervention and follow-up assessments are conducted by study personnel who are not involved in delivering the intervention. The primary purpose is to evaluate the feasibility and acceptability of study procedures and intervention delivery, while generating preliminary data to inform the design and implementation of a future definitive randomized controlled trial.
Тип исследования
Интервенционный
Регистрация (Оцененный)
50
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: Jenni Kulmala, Professor
- Номер телефона: +358 50 4395422
- Электронная почта: jenni.kulmala@tuni.fi
Учебное резервное копирование контактов
- Имя: Tiia Ngandu, MD, PhD
- Номер телефона: +358 29 524 7716
- Электронная почта: tiia.ngandu@thl.fi
Места учебы
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Tampere, Финляндия, 33520
- Tampere University
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Контакт:
- Tiia Ngandu, MD, PhD
- Номер телефона: +358 29 524 7716
- Электронная почта: tiia.ngandu@thl.fi
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Контакт:
- Jenni Kulmala, PhD, Professor
- Номер телефона: +358 50 4395422
- Электронная почта: jenni.kulmala@tuni.fi
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Главный следователь:
- Jenni Kulmala, PhD, Professor
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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
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- Aged 65 years or older
- Spousal family caregiver living in the same household as the care recipient (a formal caregiving agreement is not required)
- Participating in moderate- or vigorous-intensity physical activity fewer than two times per week
- Able to safely engage in light-to-moderate physical activity based on self-report and health screening conducted by the study nurse, with consultation from the study physician if required
- Able to understand study procedures and provide written informed consent
Exclusion Criteria:
- Diagnosed dementia, substantial cognitive impairment, or other significant neurological disease that would interfere with participation in the study
- Inability to provide informed consent or complete study assessments, as determined by study personnel
- Medical conditions that may compromise safe participation in physical activity, including but not limited to active malignant disease, severe major depression, symptomatic cardiovascular disease, or coronary or vascular revascularization within the previous 12 months
- Severe visual, hearing, speech, or other sensory or communication impairments that would prevent meaningful participation in the intervention, as determined by the study nurse
- Concurrent participation in another interventional clinical trial
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: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Caregiver-tailored physical activity intervention
Participants assigned to this arm will receive a six-month physical activity intervention designed for older family caregivers.
The intervention includes weekly supervised group-based exercise sessions and weekly remotely delivered exercise sessions.
The exercise program focuses on strength, balance, and light-to-moderate intensity aerobic activity and is adapted to participants' functional abilities.
Participants will also receive individualized goal-setting and motivational support, as well as thematic content related to health, recovery, and well-being.
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The intervention consists of a six-month physical activity program designed for older family caregivers.
The program combines weekly supervised group-based exercise sessions and weekly remotely delivered exercise sessions.
Exercise sessions include strength, balance, functional, and light-to-moderate intensity aerobic activities and are adapted to participants' functional abilities.
Participants receive individualized goal-setting and motivational support at the beginning of the program.
The intervention also includes brief guided relaxation exercises and thematic content related to healthy ageing, recovery, musculoskeletal health, physical activity, and well-being.
The program is designed to support regular physical activity while accommodating caregiving responsibilities and potential barriers to participation.
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Активный компаратор: Health education control
Participants in the control group receive general health advice during the baseline visit.
This advice is delivered verbally by study staff and focuses on lifestyle factors relevant to healthy aging.
In addition, control group participants are referred to a FINGER-ABC web-based education program, which provides evidence-based guidance on how to support brain health through lifestyle choices.
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General health advice provided at baseline and referral to a web-based educational programme
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of participants successfully recruited
Временное ограничение: 3-month recruitment period
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Ability to enroll the planned number of participants (n=50) within the recruitment period.
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3-month recruitment period
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Retention rate
Временное ограничение: From enrollment to the end of intervention at 6 months
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Proportion of participants completing the six-month trial, with a target retention rate of ≥70%.
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From enrollment to the end of intervention at 6 months
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Adherence
Временное ограничение: From enrollment to the end of intervention at 6 months
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Attendance at scheduled intervention sessions (in-person and remote), with an indicative target of ≥40% participation.
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From enrollment to the end of intervention at 6 months
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Acceptability using the Theoretical Framework of Acceptability (TFA)
Временное ограничение: From enrollment to the end of intervention at 6 months
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Theoretical Framework of Acceptability (TFA) (Sekhon et al., 2017).
The questionnaire includes items representing the seven TFA constructs, each rated on a 1-5 Likert scale.
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From enrollment to the end of intervention at 6 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Physical Activity
Временное ограничение: Baseline and 6 months
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Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ).
Higher scores indicate higher levels of physical activity.
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Baseline and 6 months
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Change in Step Count Measured by Accelerometer
Временное ограничение: Baseline and 6 months
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Change in daily step count measured using the ActiGraph Link GT9X accelerometer worn continuously for seven consecutive days and nights
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Baseline and 6 months
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Change in Self-Determined Motivation for Physical Activity
Временное ограничение: Baseline and 6 months
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Change in Behavioral Regulation in Exercise Questionnaire (BREQ2), which consists of 19 items representing five types of motivational regulation.
An overall measure of autonomous motivation for exercise is calculated for the Relative Autonomy Index (RAI).
The index score ranges from -24 to 20, where higher values represent more autonomous motivation.
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Baseline and 6 months
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Change in Chronic Stress
Временное ограничение: Baseline and 6 months
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Change in hair cortisol concentration (HCC) measured from hair samples.
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Baseline and 6 months
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Change in Stress-Related Symptoms
Временное ограничение: Baseline and 6 months
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Change in Perceived Stress Scale (PSS-14).
Values ranging 0-56, with lower scores indicating a better outcome.
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Baseline and 6 months
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Change in Positive Mental Health
Временное ограничение: Baseline and 6 months
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Change in Warwick-Edinburgh Mental Well-being Scale.
Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
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Baseline and 6 months
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Change in Depressive Symptoms
Временное ограничение: Baseline and 6 months
|
Change in Geriatric Depression Scale (GDS-15).
Values ranging 0-15, with lower scores indicating a better outcome.
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Baseline and 6 months
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Change in Physical functioning
Временное ограничение: Baseline and 6 months
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Change in Short Physical Performance Battery (SPPB) total score, including balance, chair stand performance, and walking speed tests under single-task and dual-task conditions.
Range 0-12, higher scores indicate better physical functioning.
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Baseline and 6 months
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Change in Hand Grip Strength
Временное ограничение: Baseline and 6 months
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Change in maximum hand grip strength assessed using a hydraulic hand dynamometer.
Higher values indicate greater muscle strength.
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Baseline and 6 months
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Change in Mobility
Временное ограничение: Baseline and 6 months
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Change in time required to complete the Timed Up and Go test.
Lower values indicate better mobility.
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Baseline and 6 months
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Change in Daily functioning
Временное ограничение: Baseline and 6 months
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Change in Basic and Instrumental Activities of Daily Living (I/ADL).
Higher scores indicate greater independence.
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Baseline and 6 months
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Change in Balance Confidence
Временное ограничение: Baseline and 6 months
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Activities-specific Balance Confidence (ABC) Scale (0-100%).
Higher scores indicate greater confidence.
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Baseline and 6 months
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Falls
Временное ограничение: Baseline to 12 months
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Self-reported incidence of falls
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Baseline to 12 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Bodily Pain
Временное ограничение: Baseline, 6 months, and 12 months
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Change in bodily pain subscale of the RAND-36 Health Survey.
Pain intensity during the past 4 weeks, rated on a 6-point scale ranging from no pain to very severe pain.
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Baseline, 6 months, and 12 months
|
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Change in Caregiving Experience
Временное ограничение: Baseline, 6 months, and 12 months
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Change in Carers of Older People in Europe Index (COPE).
A 15-item questionnaire in which each item is scored on a 1-4 scale.
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Baseline, 6 months, and 12 months
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Change in Sleep Duration
Временное ограничение: Baseline, 6 months, and 12 months
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Change in self-reported hours of sleep per night.
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Baseline, 6 months, and 12 months
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Change in Blood Pressure
Временное ограничение: Baseline, 6 months, and 12 months
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Systolic and diastolic blood pressure measured using standardized procedures
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Baseline, 6 months, and 12 months
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Change in Physical activity
Временное ограничение: 12 months
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Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ).
Higher scores indicate higher levels of physical activity.
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12 months
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Change in Self-Determined Motivation for Physical Activity
Временное ограничение: 12 months
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Change in Behavioral Regulation in Exercise Questionnaire (BREQ2), which consists of 19 items representing five types of motivational regulation.
An overall measure of autonomous motivation for exercise is calculated for the Relative Autonomy Index (RAI).
The index score ranges from -24 to 20, where higher values represent more autonomous motivation.
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12 months
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Change in Stress-Related Symptoms
Временное ограничение: 12 months
|
Change in Perceived Stress Scale (PSS-14).
Values ranging 0-40, with lower scores indicating a better outcome.
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12 months
|
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Change in Positive Mental Health
Временное ограничение: 12 months
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Change in Warwick-Edinburgh Mental Well-being Scale.
Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
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12 months
|
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Change in Depressive Symptoms
Временное ограничение: 12 months
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Change in Geriatric Depression Scale (GDS-15).
Values ranging 0-15, with lower scores indicating a better outcome.
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12 months
|
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Change in Physical functioning
Временное ограничение: 12 months
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Change in Short Physical Performance Battery (SPPB) total score, including balance, chair stand performance, and walking speed tests under single-task and dual-task conditions.
Range 0-12, higher scores indicate better physical functioning.
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12 months
|
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Change in Hand Grip Strength
Временное ограничение: 12 months
|
Change in maximum hand grip strength assessed using a hydraulic hand dynamometer.
Higher values indicate greater muscle strength.
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12 months
|
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Change in Timed Up and Go (TUG) test under single-task and dual-task conditions.
Временное ограничение: 12 months
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Change in time required to complete the Timed Up and Go test.
Lower values indicate better mobility.
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12 months
|
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Change in Daily functioning
Временное ограничение: 12 months
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Change in Basic and Instrumental Activities of Daily Living (I/ADL).
Higher scores indicate greater independence.
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12 months
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Change in Balance confidence
Временное ограничение: 12 months
|
Activities-specific Balance Confidence (ABC) Scale (0-100%).
Higher scores indicate greater confidence.
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12 months
|
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Change in Cognitive performance
Временное ограничение: Baseline, 6 months, and 12 months
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Change in Montreal Cognitive Assessment (MoCA) total score (range 0-30).
Higher scores indicate better cognitive function.
|
Baseline, 6 months, and 12 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
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 (Оцененный)
15 июня 2026 г.
Первичное завершение (Оцененный)
31 августа 2027 г.
Завершение исследования (Оцененный)
31 августа 2027 г.
Даты регистрации исследования
Первый отправленный
4 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
11 июня 2026 г.
Первый опубликованный (Действительный)
17 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- R26019
- 360990 (Другой номер гранта/финансирования: Research Council of Finland)
- 360824 (Другой номер гранта/финансирования: Research Council of Finland)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Описание плана IPD
IPD may not be shared due to privacy considerations
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. .