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

NCT06960005 | Enrolling By Invitation DMC

• 1 other identifier: N-20240055
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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. 1.Evaluate the need for a screening tool to identify thyroid patients with reduced health-related QoL despite being euthyroid.
2. 2.Assess the impact of the exercise intervention on body composition, strength, and balance function in HT and MNTG patients.

Conditions

Thyroid Disease; Hashimoto's Thyroiditis; Hyperthyreosis and Goiter; Hypothyroidism

Keywords

Health-related Quality of Life; Exercise intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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)

Other Outcomes (2)

• Improvement in Nerve Function

  Baseline, 26 weeks and 52 weeks

• Reduction in fall rates

  26 weeks and 52 weeks

Study Arms (2)

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.

Other: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)

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.

Interventions

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

Exercise intervention: RYMA

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Men and women with a minimum of 18 years
• Diagnosis of primary hypothyroidism or primary hyperthyroidism

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Steno Diabetes Center Nordjylland: collaborator

Study Sites (1)

Diabeteshuset

Gistrup, 9260, Denmark

Location

MeSH Terms

Conditions

Thyroid Diseases; Goiter; Hypothyroidism

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Screening and exercise intervention with Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 7, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 17, 2026

Record last verified: 2025-04

Locations

DK (1)