An interventional study of Supervised Walking Program in Hypothyroidism, sponsored by University of Karachi. Not yet recruiting at 1 site in Pakistan. Open to female participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by University of Karachi · Not applicable, Interventional, and Supportive care
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.
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 109 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →University of Karachi is the lead sponsor of 37 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion 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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 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.
Behavioral: Supervised Walking Program
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.
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.
Also known as: Aerobic walking, treadmill walking, moderate-intensity exercise
Change in Basal Metabolic Rate
Baseline (Week 0) and Week 12
Time frame: 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.
Change in Heart Rate Variability
Resting 5-minute ECG with paced breathing; RMSSD calculated after artifact correction.
Time frame: Baseline (Week 0) and Week 12
Change in Heart Rate Variability
Resting 5-minute ECG with paced breathing; SDNN calculated after artifact correction.
Time frame: 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.
Time frame: Baseline (Week 0) and Week 12
Change in Fatigue Severity Scale
Self-reported validated questionnaire; higher scores = greater fatigue.
Time frame: Baseline (Week 0) and Week 12
Change in Hospital Anxiety and Depression Scale
Self-reported validated questionnaire; higher scores = greater anxiety or depression symptoms.
Time frame: Baseline (Week 0) and Week 12
Adherence to Walking Program
Percentage of prescribed sessions completed, based on attendance logs and heart rate monitor data.
Time frame: Weekly throughout the 12-week intervention period
Adverse Events
Weekly surveillance of adverse events, classified by type, severity, and seriousness.
Time frame: From Week 1 through Week 12 (study intervention period)
Plan to share: No — 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.
Start is estimated for Nov 2025; primary completion for Apr 2026, 5 months later.
Of 27 interventional studies with no phase under Hypothyroidism, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of Karachi