Walking for Hypothyroidism Trial (WHT)

ConditionHypothyroidism

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age35-55

SponsorUniversity of Karachi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Walking InterventionExperimental treatment 1 intervention

Group B: Control (Usual Activity)No intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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

Other outcomes

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Karachi

Lead sponsor

Advanced Education & Research Center

Collaborator

Source ClinicalTrials.gov

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