An interventional study of Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) in Thyroid Disease, Hashimoto's Thyroiditis and Hyperthyreosis and Goiter, sponsored by Aalborg University Hospital. Enrolling by invitation at 1 site in Denmark. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Treatment
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:
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)
365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.
This study's planned enrollment of 148 is above the median of 88 across 198 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
For the cross sectional survey:
Inclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Participants will be screened and followed but not participate in the exercise intervention and continue their usual activities.
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
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).
Time frame: 26 weeks and 52 weeks
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
Time frame: 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
Time frame: 26 weeks and 52 weeks
Muscle Strength
Change in muscle strength assessed by handgrip strength and isometric knee extension strength (using a dynamometer).
Time frame: 26 weeks and 52 weeks
Balance Function
Change in balance function assessed through Center of Pressure (CoP).
Time frame: 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.
Time frame: Baseline (Day 1)
Improvement in Nerve Function
To estimate the change in nerve fiber function by assessing small, large, and autonomic neuropathy using standardized neurophysiological methods following the exercise intervention in patients with HT and MNTG.
Time frame: Baseline, 26 weeks and 52 weeks
Reduction in fall rates
To estimate changes in fall rates in patients aged \>65 with HT or MNTG following the RYMA intervention, compared to their baseline measures (self-controls) and to a usual care group (no RYMA).
Time frame: 26 weeks and 52 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Mar 2027, 10 months later.
Of 73 non-industry interventional studies with no phase under Thyroid Diseases, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 57. This study's planned 10 months is below that.
Counting every sponsor, half of 74 studies reached it within 19 months; a quarter within 8 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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