Walking for Hypothyroidism Trial (WHT)

Not Applicable

Not yet recruiting

• Conditions: Hypothyroidism

• Registration Number: NCT07205042
• Lead Sponsor: University of Karachi

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-13
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-11-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Female, aged 35-55 years
• Primary hypothyroidism with documented prior TSH >4.5 mIU/L
• Stable levothyroxine dose for at least 6 months
• Sedentary lifestyle (<150 minutes of moderate-vigorous activity per week)
• BMI between 20-35 kg/m²
• Able to walk unaided
• Willing and able to provide written informed consent

Exclusion Criteria

• Pregnant or lactating, or planning pregnancy during the study period
• Use of beta-blockers, systemic corticosteroids, or medications significantly affecting heart rate, HRV, or metabolism
• Uncontrolled hypertension, insulin-dependent diabetes, symptomatic cardiovascular disease, or orthopedic conditions limiting walking
• Major psychiatric hospitalization in the past 12 months
• Participation in another interventional trial within the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Basal Metabolic Rate	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.	Baseline (Week 0) and Week 12

Secondary Outcome Measures

Name	Time	Method
Change in Heart Rate Variability	Baseline (Week 0) and Week 12	Resting 5-minute ECG with paced breathing; SDNN calculated after artifact correction.
Change in Hospital Anxiety and Depression Scale	Baseline (Week 0) and Week 12	Self-reported validated questionnaire; higher scores = greater anxiety or depression symptoms.
Change in Morning Salivary Cortisol	Baseline (Week 0) and Week 12	Triplicate saliva samples collected at 08:00 h on two weekdays, pooled and assayed via ELISA.
Change in Fatigue Severity Scale	Baseline (Week 0) and Week 12	Self-reported validated questionnaire; higher scores = greater fatigue.

Trial Locations

Locations (1)

University of Karachi; 🇵🇰 Karachi, Sindh, Pakistan