Clinical trial NCT06960005: ThyMoves: Screening and Exercise to Improve Muscle, Enhance Quality of Life, and Reduce Fall Risk in Thyroid Disease
Official title: Screening and Exercise Intervention to Improve Muscle Performance, Reduce Risk of Falls, and Enhance Quality of Life in Thyroid Hormone Disease: ThyMoves
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Disease
Hashimoto&#39;s Thyroiditis
Hyperthyreosis and Goiter
Hypothyroidism
Keywords: Health-related Quality of Life
Exercise intervention
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Nordjylland
First posted: 2025-05-07
Enrollment: 148
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Screening and exercise intervention with Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change in Health-Related Quality of Life after the Exercise Intervention
timeFrame: 26 weeks and 52 weeks
Secondary outcomes:
measure: Changes in Muscle Mass
timeFrame: 26 weeks and 52 weeks
measure: Changes in Fat Mass Distribution
timeFrame: 26 weeks and 52 weeks
measure: Muscle Strength
timeFrame: 26 weeks and 52 weeks
measure: Balance Function
timeFrame: 26 weeks and 52 weeks
measure: Identification of Patients with Reduced Health-Related Quality of Life
timeFrame: Baseline (Day 1)
Other outcomes:
measure: Improvement in Nerve Function
timeFrame: Baseline, 26 weeks and 52 weeks
measure: Reduction in fall rates
timeFrame: 26 weeks and 52 weeks
Locations:
city: Gistrup
country: Denmark
facility: Diabeteshuset
Study officials:
References: