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Enrolling by invitation NCT06960005

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

No phase Interventional Thyroid Disease Hashimoto's Thyroiditis Hyperthyreosis and Goiter Hypothyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL).
Who it may be relevant to
Registry conditions: Thyroid Disease, Hashimoto's Thyroiditis, Hyperthyreosis and Goiter, Hypothyroidism. Basic parameters: from 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other 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

Primary outcome measures

  • Change in Health-Related Quality of Life after the Exercise Intervention [Time frame: 26 weeks and 52 weeks]
Secondary outcome measures (5)
  • Changes in Muscle Mass [Time frame: 26 weeks and 52 weeks]
  • Changes in Fat Mass Distribution [Time frame: 26 weeks and 52 weeks]
  • Muscle Strength [Time frame: 26 weeks and 52 weeks]
  • Balance Function [Time frame: 26 weeks and 52 weeks]
  • Identification of Patients with Reduced Health-Related Quality of Life [Time frame: Baseline (Day 1)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Diabeteshuset — Gistrup

Identifiers

NCT: NCT06960005 · N-20240055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗