Walking for Hypothyroidism Trial (WHT)
WHT
A Randomized Controlled Trial of a 12-Week Walking Program on Metabolic and Psychophysiological Outcomes in Women With Hypothyroidism
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedOctober 3, 2025
September 1, 2025
6 months
September 13, 2025
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Basal Metabolic Rate
Baseline (Week 0) and Week 12
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 (5)
Change in Heart Rate Variability
Baseline (Week 0) and Week 12
Change in Heart Rate Variability
Baseline (Week 0) and Week 12
Change in Morning Salivary Cortisol
Baseline (Week 0) and Week 12
Change in Fatigue Severity Scale
Baseline (Week 0) and Week 12
Change in Hospital Anxiety and Depression Scale
Baseline (Week 0) and Week 12
Other Outcomes (2)
Adherence to Walking Program
Weekly throughout the 12-week intervention period
Adverse Events
From Week 1 through Week 12 (study intervention period)
Study Arms (2)
Walking Intervention
EXPERIMENTALParticipants 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.
Control (Usual Activity)
NO INTERVENTIONParticipants 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.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Karachilead
- Advanced Education & Research Centercollaborator
Study Sites (1)
University of Karachi
Karachi, Sindh, 78500, Pakistan
Related Publications (4)
Sundus H, Khan SA, Zaidi S, Chhabra C, Ahmad I, Khan H. Effect of long-term exercise-based interventions on thyroid function in hypothyroidism: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2025 Sep;92:103196. doi: 10.1016/j.ctim.2025.103196. Epub 2025 May 28.
PMID: 40446861BACKGROUNDDunabeitia I, Gonzalez-Devesa D, Varela-Martinez S, Diz-Gomez JC, Ayan-Perez C. Effect of physical exercise in people with hypothyroidism: systematic review and meta-analysis. Scand J Clin Lab Invest. 2023 Dec;83(8):523-532. doi: 10.1080/00365513.2023.2286651. Epub 2024 Jan 24.
PMID: 37999992BACKGROUNDMathene Koteles E, Rafael B, Korom A, Vagvolgyi A, Abraham JE, Domjan A, Szucs M, Nemes A, Barnai M, Lengyel C, Kosa I. Physiological and psychological effects of a 12-week home-based telemonitored training in metabolic syndrome. Front Cardiovasc Med. 2023 Jan 10;9:1075361. doi: 10.3389/fcvm.2022.1075361. eCollection 2022.
PMID: 36704473BACKGROUNDAhmad AM, Serry ZH, Abd Elghaffar HA, Ghazi HA, El Gayar SL. Effects of aerobic, resistance, and combined training on thyroid function and quality of life in hypothyroidism. A randomized controlled trial. Complement Ther Clin Pract. 2023 Nov;53:101795. doi: 10.1016/j.ctcp.2023.101795. Epub 2023 Aug 22.
PMID: 37659172BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sadaf Ahmed, Ph.D.
University of Karachi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The walking program cannot be blinded to participants or exercise staff. However, outcome assessors (BMR testing, HRV analysis, cortisol assays) and statisticians will be blinded to group allocation.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 13, 2025
First Posted
October 3, 2025
Study Start
November 1, 2025
Primary Completion
April 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
October 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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.