Walking for Hypothyroidism Trial (WHT)

N/ANot Yet RecruitingNCT07205042

University of Karachi120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

120

Conditions

Hypothyroidism

Interventions

Supervised Walking ProgramBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Karachi

Karachi, Sindh, Pakistan

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.