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Набор по приглашению NCT06960005

ThyMoves: Screening and Exercise to Improve Muscle, Enhance Quality of Life, and Reduce Fall Risk in Thyroid Disease

Без фазы С лечением Thyroid Disease Hashimoto's Thyroiditis Hyperthyreosis and Goiter Hypothyroidism

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: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL).
Кому может быть актуально
Состояния в реестре: Thyroid Disease, Hashimoto's Thyroiditis, Hyperthyreosis and Goiter, Hypothyroidism. Базовые параметры: от 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

Screening and Exercise Intervention to Improve Muscle Performance, Reduce Risk of Falls, and Enhance Quality of Life in Thyroid Hormone Disease: ThyMoves

Обзор

Objectives: This study aims to assess health-related quality of life (QoL) in adults with thyroid hormone disorders and identify modifiable factors to improve QoL in patients with Hashimoto's thyroiditis (HT) and multinodular toxic goiter (MNTG) through an exercise intervention. Primary Outcome: 1\. Assess the impact of a tailored exercise program on health-related QoL in patients with HT and MNTG using the ThyPRO questionnaire. Secondary Outcomes: 1. Evaluate the need for a screening tool to identify thyroid patients with reduced health-related QoL despite being euthyroid. 2. Assess the impact of the exercise intervention on body composition, strength, and balance function in HT and MNTG patients. Methods: The study is a combined cross-sectional survey and randomized controlled trial into the health related QoL in patients diagnosed with thyroid hormone disease. The cross-sectional survey will assess the overall health-related QoL in patients diagnosed with thyroid hormone disease, and help identify eligible participants for the subsequent RCT. The RCT will evaluate the efficacy of a comprehensive screening and exercise intervention in patients ≥ 65 years diagnosed with HT or MNTG, experiencing reduced health-related QoL. Participants: The aim is to recruit 74 patients with HT and 74 patients with MNTG, including 50 participants from each group with reduced health-related QoL (defined in this study as ThyPRO score ≥ 30) and 24 with good health-related QoL (ThyPRO score ≤ 20)

Вмешательства

  • Другое Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
    Participants will engage in one-hour exercise sessions twice weekly for 26 weeks: one day of RYMA training and one day of ADL-based training

Первичные конечные точки

  • Change in Health-Related Quality of Life after the Exercise Intervention [Срок оценки: 26 weeks and 52 weeks]
Вторичные конечные точки (5)
  • Changes in Muscle Mass [Срок оценки: 26 weeks and 52 weeks]
  • Changes in Fat Mass Distribution [Срок оценки: 26 weeks and 52 weeks]
  • Muscle Strength [Срок оценки: 26 weeks and 52 weeks]
  • Balance Function [Срок оценки: 26 weeks and 52 weeks]
  • Identification of Patients with Reduced Health-Related Quality of Life [Срок оценки: Baseline (Day 1)]

Критерии участия

Критерии включения

  • Women with minimum 65 years of age, with no upper limit.
  • Verified diagnosis of HT or MNTG
  • Euthyroid for at least 6 months
  • Signed the informed consent

Критерии исключения

  • Current participation in a structured exercise program or regular physical exercise activity above 5 hours per week
  • Previous experience with rhythm-based multitask exercise.
  • Diagnosed with significant neurological diseases (e.g. Multiple Sclerosis and myasthenia gravis), vestibular diseases or newly orthopedic surgeries (e.g. knee or hip replacement)
  • Fully dependent on walking aids
  • Active malignancy or terminal illness
  • Inability to understand Danish written and/or verbally
  • Having severely impaired cognitive function, defined as a score below 8 on the cognitive assessment "the short orientation-memory-concentration test"
  • Treatment with amiodarone within the last year
  • No changes within the last six months in medications affecting weight or body composition - e.g., GLP-1 electrolyte/fluid balance - e.g., diuretics or corticosteroid
  • Participation in other clinical intervention studies within the last six months

For the cross sectional survey:

Критерии включения

  • Men and women with a minimum of 18 years
  • Diagnosis of primary hypothyroidism or primary hyperthyroidism

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

Дания · 1 центр
  • Diabeteshuset — Gistrup

Идентификаторы

NCT: NCT06960005 · N-20240055

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗