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NCT Number: NCT07205042

Walking for Hypothyroidism Trial (WHT)

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Aerobic walking, treadmill walking, moderate-intensity exercise

Primary outcomes

  1. Change in Basal Metabolic Rate

    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.

    Baseline (Week 0) and Week 12

Secondary outcomes

  1. Change in Heart Rate Variability

    Time frame: Baseline (Week 0) and Week 12

    Resting 5-minute ECG with paced breathing; RMSSD calculated after artifact correction.

  2. Change in Heart Rate Variability

    Time frame: Baseline (Week 0) and Week 12

    Resting 5-minute ECG with paced breathing; SDNN calculated after artifact correction.

  3. Change in Morning Salivary Cortisol

    Time frame: Baseline (Week 0) and Week 12

    Triplicate saliva samples collected at 08:00 h on two weekdays, pooled and assayed via ELISA.

  4. Change in Fatigue Severity Scale

    Time frame: Baseline (Week 0) and Week 12

    Self-reported validated questionnaire; higher scores = greater fatigue.

  5. Change in Hospital Anxiety and Depression Scale

    Time frame: Baseline (Week 0) and Week 12

    Self-reported validated questionnaire; higher scores = greater anxiety or depression symptoms.

Other outcomes

  1. Adherence to Walking Program

    Time frame: Weekly throughout the 12-week intervention period

    Percentage of prescribed sessions completed, based on attendance logs and heart rate monitor data.

  2. Adverse Events

    Time frame: From Week 1 through Week 12 (study intervention period)

    Weekly surveillance of adverse events, classified by type, severity, and seriousness.

Study contacts

Contact information is provided by the study sponsor or research team.

Sadaf Ahmed, Ph.D.

CONTACT

[email protected]

+923333061127

Shamoon Noushad, Ph.D.

CONTACT

[email protected]

+923333549258

Sponsors and collaborators

Lead sponsor

University of Karachi

Other

Collaborators

  • Advanced Education & Research Center

Registry information

Official study title

A Randomized Controlled Trial of a 12-Week Walking Program on Metabolic and Psychophysiological Outcomes in Women With Hypothyroidism

Acronym: WHT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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