Thyroid DiseaseThyMovesNCT06960005
ThyMoves: Screening and Exercise to Improve Muscle, Enhance Quality of Life, and Reduce Fall Risk in Thyroid Disease
A study testing Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) in people with Thyroid Disease and Hashimoto's Thyroiditis, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Thyroid Disease, Hashimoto's Thyroiditis, Hyperthyreosis and Goiter
- What is being tested?
- Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
- Men and women with a minimum of 18 years
- Diagnosis of primary hypothyroidism or primary hyperthyroidism
Who cannot join
- 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
Show all 11Show fewer
- 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:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Screening and Exercise Intervention to Improve Muscle Performance, Reduce Risk of Falls, and Enhance Quality of Life in Thyroid Hormone Disease: ThyMoves
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.
Read more
Primary Outcome:
- Assess the impact of a tailored exercise program on health-related QoL in patients with HT and MNTG using the ThyPRO questionnaire.
Secondary Outcomes:
- Evaluate the need for a screening tool to identify thyroid patients with reduced health-related QoL despite being euthyroid.
- 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)
- Being tested
- Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
- Keywords
- Health-related Quality of Life, Exercise intervention
- Medical subject headings
- Thyroid Diseases, Goiter, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 26 weeks and 52 weeks
Secondary outcomes (5)
Changes in Muscle Mass
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
Measured: 26 weeks and 52 weeks
Changes in Fat Mass Distribution
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
Measured: 26 weeks and 52 weeks
Muscle Strength
Change in muscle strength assessed by handgrip strength and isometric knee extension strength (using a dynamometer).
Measured: 26 weeks and 52 weeks
Balance Function
Change in balance function assessed through Center of Pressure (CoP).
Measured: 26 weeks and 52 weeks
Identification of Patients with Reduced Health-Related Quality of Life
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.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start15 May 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Screening and exercise intervention with Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland
- Responsible party
- Principal investigator, Mia Daugaard Madsen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960005
- Sponsor's protocol ID
- N-20240055
- Acronym
- ThyMoves
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Exercise Intervention to Improve Muscle Performance, Reduce Risk of Falls, and Enhance Quality of Life in Thyroid Hormone Disease: ThyMoves
- ClinicalTrials.gov ID
- NCT06960005
- Acronym / sponsor ID
- ThyMoves / N-20240055
- Keywords
- Health-related Quality of Life, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the impact of a tailored exercise program on health-related QoL in patients with HT and MNTG using the ThyPRO questionnaire.
Secondary Outcomes:
- Evaluate the need for a screening tool to identify thyroid patients with reduced health-related QoL despite being euthyroid.
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Screening and exercise intervention with Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention: RYMA | Experimental | Other: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
- Men and women with a minimum of 18 years
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Exercise intervention: RYMA |
Primary outcome
Change in Health-Related Quality of Life after the Exercise Intervention
Time frame: 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).
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) in people with Thyroid Disease and Hashimoto's Thyroiditis, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-Related Quality of Life after the Exercise Intervention (time frame: 26 weeks and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.