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

NCT ID: NCT06960005

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-11-30

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise intervention: RYMA

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Control group: Usual Care/No Structured Exercise Intervention

Participants will be screened and followed but not participate in the exercise intervention and continue their usual activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

1. Men and women with a minimum of 18 years

2. Diagnosis of primary hypothyroidism or primary hyperthyroidism

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:

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Nordjylland

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mia Daugaard Madsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diabeteshuset

Gistrup, , Denmark

Countries

Denmark

Central Contacts

Mia Daugaard Madsen, Medical Doctor

Role: CONTACT

mia.daugaard@rn.dk

+45 31 93 77 20

Peter Vestergaard, MD, PhD, Professor

Role: CONTACT

p.vestergaard@rn.dk

Other Identifiers

N-20240055

Identifier Type: -

Identifier Source: org_study_id