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| Name | Class |
|---|---|
| Steno Diabetes Center Nordjylland | OTHER |
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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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention: RYMA | Experimental | 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. |
|
| Control group: Usual Care/No Structured Exercise Intervention | No Intervention | Participants will be screened and followed but not participate in the exercise intervention and continue their usual activities. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health-Related Quality of Life after the Exercise Intervention | 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). | 26 weeks and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Muscle Mass | Full body Dual-Energy X-ray Absorptiometry (DXA) scans will be used to assess changes in muscle mass. These outcomes will evaluate whether the intervention influences muscle quality over time, with comparisons between intervention and control groups | 26 weeks and 52 weeks |
| Changes in Fat Mass Distribution |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Nerve Function | To estimate the change in nerve fiber function by assessing small, large, and autonomic neuropathy using standardized neurophysiological methods following the exercise intervention in patients with HT and MNTG. | Baseline, 26 weeks and 52 weeks |
| Reduction in fall rates |
Inclusion Criteria:
Exclusion Criteria:
For the cross sectional survey:
Inclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabeteshuset | Gistrup | 9260 | Denmark |
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Screening and exercise intervention with Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
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Full-body DXA scans will be used to assess changes in fat mass distribution over time. Comparisons will be made between intervention and control groups |
| 26 weeks and 52 weeks |
| Muscle Strength | Change in muscle strength assessed by handgrip strength and isometric knee extension strength (using a dynamometer). | 26 weeks and 52 weeks |
| Balance Function | Change in balance function assessed through Center of Pressure (CoP). | 26 weeks and 52 weeks |
| Identification of Patients with Reduced Health-Related Quality of Life | To assess the potential need for future implementation of health-related quality of life (HRQoL) screening in patients with thyroid hormone disease, based on the number of patients identified with reduced HRQoL using the Thyroid-Related Quality of Life Questionnaire (ThyPRO). The ThyPRO includes 85 items across 13 scales and one overall impact item. Scores range from 0 to 100, with higher scores indicating worse health status. | Baseline (Day 1) |
To estimate changes in fall rates in patients aged >65 with HT or MNTG following the RYMA intervention, compared to their baseline measures (self-controls) and to a usual care group (no RYMA). |
| 26 weeks and 52 weeks |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D006042 | Goiter |
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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