Screening and Exercise Intervention to Improve Muscle Performance, Reduce Risk of Falls, and Enhance Quality of Life in Thyroid Hormone Disease: ThyMoves
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Change in Health-Related Quality of Life after the Exercise Intervention
研究概览
简要总结
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:
- Evaluate the need for a screening tool to identify thyroid patients with reduced health-related QoL despite being euthyroid.
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •Inclusion criteria:
- •Men and women with a minimum of 18 years
- •Diagnosis of primary hypothyroidism or primary hyperthyroidism
研究组 & 干预措施
Exercise intervention: RYMA
Participants in this arm will engage in the Rhythm- and Multitask-Based Activity (RYMA) program, a 26-week multicomponent exercise intervention designed to enhance quality of life, improve physical function, and prevent falls. The program integrates strength, balance, coordination, and cognitive-motor training, along with Activities of Daily Living (ADL)-based exercises to support real-world functionality.
干预措施: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) (Other)
Control group: Usual Care/No Structured Exercise Intervention
Participants will be screened and followed but not participate in the exercise intervention and continue their usual activities.
结局指标
主要结局
Change in Health-Related Quality of Life after the Exercise Intervention
时间窗: 26 weeks and 52 weeks
The Thyroid-Related Quality of Life Measure questionnaire (ThyPRO) consists of 85 items summarized into 13 scales and one single item measuring the overall impact of thyroid disease on quality of life. It includes questions on symptoms, mood, memory, tiredness, and general health. Each item is rated on a 0-4 Likert scale, with scores transformed to a 0-100 scale; higher scores indicate worse health status. The ThyPRO questionnaire wil be used to assess changes in health-related QoL at 26 weeks (post-intervention) and 52 weeks (follow-up).
次要结局
- Changes in Muscle Mass(26 weeks and 52 weeks)
- Changes in Fat Mass Distribution(26 weeks and 52 weeks)
- Muscle Strength(26 weeks and 52 weeks)
- Balance Function(26 weeks and 52 weeks)
- Identification of Patients with Reduced Health-Related Quality of Life(Baseline (Day 1))
研究者
Mia Daugaard Madsen
Principal Investigator
Aalborg University Hospital