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| Name | Class |
|---|---|
| Advanced Education & Research Center | OTHER |
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Women with hypothyroidism often report persistent fatigue, weight gain, autonomic dysregulation, and stress despite stable levothyroxine therapy. This single-center, parallel-group RCT will test whether a structured, supervised 12-week walking program improves basal metabolic rate (BMR) and psychophysiological outcomes compared with usual activity. One hundred twenty women aged 35-55 with stable primary hypothyroidism will be randomized 1:1 to intervention or control.
This trial evaluates a pragmatic, low-cost aerobic intervention-walking 30 minutes/day, 5 days/week at 55-65% HRmax for 12 weeks-as an adjunct to standard pharmacotherapy. Expected benefits: ↑BMR, ↑HRV, ↓cortisol, ↓fatigue, and improved mood. Outcome assessors/statisticians are masked; allocation is concealed. Safety monitoring covers musculoskeletal events, cardiovascular symptoms, and thyroid-related issues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking Intervention | Experimental | Participants will undergo a supervised walking program consisting of 30 minutes per session, 5 sessions per week, for 12 weeks. Exercise intensity will be maintained at 55-65% of age-predicted maximum heart rate, monitored by chest strap or optical heart rate sensors. Sessions will be supervised by an exercise physiologist, with adherence tracked through session logs and heart rate recordings. Participants will continue their usual levothyroxine regimen but will not initiate any new structured exercise program during the study period. |
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| Control (Usual Activity) | No Intervention | Participants will continue their usual daily routines without a prescribed exercise program. They will be instructed not to initiate any new structured exercise during the study. Weekly check-ins will be conducted to record incidental activity and monitor health status. At study completion, control participants will be offered the walking program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised Walking Program | Behavioral | A structured walking program consisting of 30 minutes per session, 5 sessions per week, for 12 weeks at 55-65% of age-predicted maximum heart rate. Sessions will be supervised by an exercise physiologist, with adherence monitored by heart rate tracking and attendance logs. Participants will continue their standard levothyroxine treatment but will not begin any new structured exercise programs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Basal Metabolic Rate | Baseline (Week 0) and Week 12 | Basal metabolic rate (BMR) measured via indirect calorimetry under standardized conditions (fasted, thermoneutral room, supine rest ≥30 minutes). The primary analysis will compare change from baseline to 12 weeks between intervention and control groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability | Resting 5-minute ECG with paced breathing; RMSSD calculated after artifact correction. | Baseline (Week 0) and Week 12 |
| Change in Heart Rate Variability | Resting 5-minute ECG with paced breathing; SDNN calculated after artifact correction. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Walking Program | Percentage of prescribed sessions completed, based on attendance logs and heart rate monitor data. | Weekly throughout the 12-week intervention period |
| Adverse Events | Weekly surveillance of adverse events, classified by type, severity, and seriousness. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shamoon Noushad, Ph.D. | Contact | +923333549258 | shamoon@aeirc-edu.com | |
| Sadaf Ahmed, Ph.D. | Contact | +923333061127 | sadaf@aeirc-edu.com |
| Name | Affiliation | Role |
|---|---|---|
| Sadaf Ahmed, Ph.D. | University of Karachi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Karachi | Karachi | Sindh | 78500 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40446861 | Background | Sundus H, Khan SA, Zaidi S, Chhabra C, Ahmad I, Khan H. Effect of long-term exercise-based interventions on thyroid function in hypothyroidism: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2025 Sep;92:103196. doi: 10.1016/j.ctim.2025.103196. Epub 2025 May 28. | |
| 37999992 | Background |
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The individual participant data (IPD) collected during this study will not be made publicly available due to ethical and privacy considerations. Summary results will be disseminated in scientific publications and presentations.
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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Participants will be randomized 1:1 into two arms: (1) a 12-week supervised walking program and (2) a control group maintaining usual activity. Each group is followed in parallel for the full duration of the study.
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The walking program cannot be blinded to participants or exercise staff. However, outcome assessors (BMR testing, HRV analysis, cortisol assays) and statisticians will be blinded to group allocation.
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| Baseline (Week 0) and Week 12 |
| Change in Morning Salivary Cortisol | Triplicate saliva samples collected at 08:00 h on two weekdays, pooled and assayed via ELISA. | Baseline (Week 0) and Week 12 |
| Change in Fatigue Severity Scale | Self-reported validated questionnaire; higher scores = greater fatigue. | Baseline (Week 0) and Week 12 |
| Change in Hospital Anxiety and Depression Scale | Self-reported validated questionnaire; higher scores = greater anxiety or depression symptoms. | Baseline (Week 0) and Week 12 |
| From Week 1 through Week 12 (study intervention period) |
| Dunabeitia I, Gonzalez-Devesa D, Varela-Martinez S, Diz-Gomez JC, Ayan-Perez C. Effect of physical exercise in people with hypothyroidism: systematic review and meta-analysis. Scand J Clin Lab Invest. 2023 Dec;83(8):523-532. doi: 10.1080/00365513.2023.2286651. Epub 2024 Jan 24. |
| 36704473 | Background | Mathene Koteles E, Rafael B, Korom A, Vagvolgyi A, Abraham JE, Domjan A, Szucs M, Nemes A, Barnai M, Lengyel C, Kosa I. Physiological and psychological effects of a 12-week home-based telemonitored training in metabolic syndrome. Front Cardiovasc Med. 2023 Jan 10;9:1075361. doi: 10.3389/fcvm.2022.1075361. eCollection 2022. |
| 37659172 | Background | Ahmad AM, Serry ZH, Abd Elghaffar HA, Ghazi HA, El Gayar SL. Effects of aerobic, resistance, and combined training on thyroid function and quality of life in hypothyroidism. A randomized controlled trial. Complement Ther Clin Pract. 2023 Nov;53:101795. doi: 10.1016/j.ctcp.2023.101795. Epub 2023 Aug 22. |