Hashimoto's Thyroiditis, Hyperthyreosis and Goiter, Hypothyroidism, Thyroid Disease
Conditions
Keywords
Health-related Quality of Life, Exercise intervention
Brief summary
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)
Interventions
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
Sponsors
Aalborg University Hospital
Steno Diabetes Center Nordjylland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Screening and exercise intervention with Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women with minimum 65 years of age, with no upper limit. 2. Verified diagnosis of HT or MNTG 3. Euthyroid for at least 6 months 4. Signed the informed consent
Exclusion criteria
1. Current participation in a structured exercise program or regular physical exercise activity above 5 hours per week 2. Previous experience with rhythm-based multitask exercise. 3. Diagnosed with significant neurological diseases (e.g. Multiple Sclerosis and myasthenia gravis), vestibular diseases or newly orthopedic surgeries (e.g. knee or hip replacement) 4. Fully dependent on walking aids 5. Active malignancy or terminal illness 6. Inability to understand Danish written and/or verbally 7. Having severely impaired cognitive function, defined as a score below 8 on the cognitive assessment "the short orientation-memory-concentration test" 8. Treatment with amiodarone within the last year 9. 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 10. Participation in other clinical intervention studies within the last six months For the cross sectional survey: Inclusion criteria: 1. Men and women with a minimum of 18 years 2. Diagnosis of primary hypothyroidism or primary hyperthyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life after the Exercise Intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Muscle Mass | 26 weeks and 52 weeks | 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 |
| Changes in Fat Mass Distribution | 26 weeks and 52 weeks | 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 |
| Muscle Strength | 26 weeks and 52 weeks | Change in muscle strength assessed by handgrip strength and isometric knee extension strength (using a dynamometer). |
| Balance Function | 26 weeks and 52 weeks | Change in balance function assessed through Center of Pressure (CoP). |
| Identification of Patients with Reduced Health-Related Quality of Life | Baseline (Day 1) | 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. |
Countries
Denmark
Outcome results
None listed