Walking for Hypothyroidism Trial (WHT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supervised Walking Program.
- Who it may be relevant to
- Registry conditions: Hypothyroidism. Basic parameters: 35 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial of a 12-Week Walking Program on Metabolic and Psychophysiological Outcomes in Women With Hypothyroidism
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.
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.
Interventions
- Behavioral Supervised Walking Program
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.
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- Change in Heart Rate Variability [Time frame: Baseline (Week 0) and Week 12]
- Change in Heart Rate Variability [Time frame: Baseline (Week 0) and Week 12]
- Change in Morning Salivary Cortisol [Time frame: Baseline (Week 0) and Week 12]
- Change in Fatigue Severity Scale [Time frame: Baseline (Week 0) and Week 12]
- Change in Hospital Anxiety and Depression Scale [Time frame: Baseline (Week 0) and Week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Pakistan · 1 center
- University of Karachi — Karachi
Publications
- 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 40446861
- Dunabeitia 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 37999992
- Mathene 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 36704473
- Ahmad 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 37659172
Identifiers
NCT: NCT07205042 · AEIRC-KU-2025-WHT01