A Randomized Controlled Trial of a 12-Week Walking Program on Metabolic and Psychophysiological Outcomes in Women With Hypothyroidism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Basal Metabolic Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Basal Metabolic Rate
时间窗: 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
Change in Basal Metabolic Rate
时间窗: 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
次要结局
- Change in Heart Rate Variability(Baseline (Week 0) and Week 12)
- Change in Morning Salivary Cortisol(Baseline (Week 0) and Week 12)
- Change in Fatigue Severity Scale(Baseline (Week 0) and Week 12)
- Change in Hospital Anxiety and Depression Scale(Baseline (Week 0) and Week 12)
- Change in Heart Rate Variability(Baseline (Week 0) and Week 12)
- Change in Hospital Anxiety and Depression Scale(Baseline (Week 0) and Week 12)
- Change in Morning Salivary Cortisol(Baseline (Week 0) and Week 12)
- Change in Fatigue Severity Scale(Baseline (Week 0) and Week 12)
研究者
Shamoon Noushad
Professor
University of Karachi