Walking for Hypothyroidism Trial (WHT)

University of Karachi

Status: Not yet enrolling

Conditions: Hypothyroidism

Treatments: Behavioral: Supervised Walking Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07205042

AEIRC-KU-2025-WHT01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Walking Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Supervised Walking Program

Control (Usual Activity)

No Intervention group

Description:

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.