Hypothyroidism
Conditions
Keywords
Walking, Aerobic Exercise, Basal Metabolic Rate, Heart Rate Variability, Salivary Cortisol
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.
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
BEHAVIORALSupervised 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.
Sponsors
Advanced Education & Research Center
University of Karachi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Basal Metabolic Rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability | Baseline (Week 0) and Week 12 | Resting 5-minute ECG with paced breathing; RMSSD calculated after artifact correction. |
| Change in Morning Salivary Cortisol | Baseline (Week 0) and Week 12 | Triplicate saliva samples collected at 08:00 h on two weekdays, pooled and assayed via ELISA. |
| Change in Fatigue Severity Scale | Baseline (Week 0) and Week 12 | Self-reported validated questionnaire; higher scores = greater fatigue. |
| Change in Hospital Anxiety and Depression Scale | Baseline (Week 0) and Week 12 | Self-reported validated questionnaire; higher scores = greater anxiety or depression symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Walking Program | Weekly throughout the 12-week intervention period | Percentage of prescribed sessions completed, based on attendance logs and heart rate monitor data. |
| Adverse Events | From Week 1 through Week 12 (study intervention period) | Weekly surveillance of adverse events, classified by type, severity, and seriousness. |
Countries
Pakistan
Contacts
Primary ContactShamoon Noushad, Ph.D.
Backup ContactSadaf Ahmed, Ph.D.
Outcome results
None listed