Walking for Hypothyroidism Trial (WHT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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

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Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Walking Intervention

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.

Group Type EXPERIMENTAL

Supervised Walking Program

Intervention Type 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.

Control (Usual Activity)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Aerobic walking, treadmill walking, moderate-intensity exercise

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No