HypothyroidismWHTNCT07205042
Walking for Hypothyroidism Trial (WHT)
A study testing Supervised Walking Program in people with Hypothyroidism, run by University of Karachi at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Supervised Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
University of Karachi
Karachi, Sindh, 78500
Shamoon Noushad, 03333549258, shamoon@aeirc-edu.com
About this study
Official title: A Randomized Controlled Trial of a 12-Week Walking Program on Metabolic and Psychophysiological Outcomes in Women With Hypothyroidism
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.
Read the 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.
- Conditions
- Hypothyroidism
- Being tested
- Supervised Walking Program
- Keywords
- Walking, Aerobic Exercise, Basal Metabolic Rate, Heart Rate Variability, Salivary Cortisol
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Walking ProgramBehavioural
Also called Aerobic walking, treadmill walking, moderate-intensity exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking Intervention | Experimental | Participants 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. Receives: Behavioral: Supervised Walking Program |
| Control (Usual Activity) | No intervention | Participants 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Basal Metabolic Rate
Baseline (Week 0) and Week 12
Measured: 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
Resting 5-minute ECG with paced breathing; RMSSD calculated after artifact correction.
Measured: Baseline (Week 0) and Week 12
Change in Heart Rate Variability
Resting 5-minute ECG with paced breathing; SDNN calculated after artifact correction.
Measured: 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.
Measured: Baseline (Week 0) and Week 12
Change in Fatigue Severity Scale
Self-reported validated questionnaire; higher scores = greater fatigue.
Measured: Baseline (Week 0) and Week 12
Change in Hospital Anxiety and Depression Scale
Self-reported validated questionnaire; higher scores = greater anxiety or depression symptoms.
Measured: Baseline (Week 0) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 into two arms: (1) a 12-week supervised walking program and (2) a control group maintaining usual activity. Each group is followed in parallel for the full duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Education & Research Center
- Responsible party
- Principal investigator, Shamoon Noushad, University of Karachi
- Investigators
- Sadaf Ahmed, Ph.D., Principal investigator, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205042
- Sponsor's protocol ID
- AEIRC-KU-2025-WHT01
- Acronym
- WHT
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 40446861Dunabeitia 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.
PubMed 37999992Mathene 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.
PubMed 36704473Ahmad 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.
PubMed 37659172
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a 12-Week Walking Program on Metabolic and Psychophysiological Outcomes in Women With Hypothyroidism
- ClinicalTrials.gov ID
- NCT07205042
- Acronym / sponsor ID
- WHT / AEIRC-KU-2025-WHT01
- Conditions
- Hypothyroidism
- Keywords
- Walking, Aerobic Exercise, Basal Metabolic Rate, Heart Rate Variability, Salivary Cortisol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Advanced Education & Research Center
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 into two arms: (1) a 12-week supervised walking program and (2) a control group maintaining usual activity. Each group is followed in parallel for the full duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Walking Intervention | Experimental | Behavioral: Supervised Walking ProgramParticipants 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 intervention | –Participants 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. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Walking ProgramAlso: Aerobic walking, treadmill walking, moderate-intensity exerciseA 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. | Behavioural | Walking Intervention |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 40446861Sundus 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.
- Background: PubMed 37999992Dunabeitia 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.
- Background: PubMed 36704473Mathene 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.
- Background: PubMed 37659172Ahmad 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.
- Individual participant dataSharing planned: No. 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.
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Hypothyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sadaf Ahmed, Ph.D. principal investigator
University of Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Walking Program in people with Hypothyroidism, run by University of Karachi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shamoon Noushad, Ph.D. (+923333549258, shamoon@aeirc-edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07205042, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.