Comparative Effects of Aerobic and Muscle Relaxation Exercises in Pregnant Women With Restless Leg Syndrome
Comparative Effects of Aerobic and Muscle Relaxation Exercises to Improve Sleep Quality, Fatigue Level, Pain Intensity and Quality of Life in Pregnant Women With Restless Leg Syndrome
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Imran Amjad, PhD
- 电话号码:03324390125
- 邮箱:imran.amjad@riphah.edu.pk
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54770
- 招聘中
- Valencia health clinic
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首席研究员:
- Sadia Gulzar, MSWHPT
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
Pregnant women diagnosed with Restless Leg Syndrome based on clinical criteria.
- Gestational age between 20 to 34 weeks.
- Age range between 20-40 years.
- Experiencing moderate to severe sleep disturbance as per Pittsburgh Sleep Quality Index (PSQI score >5).
- Complaints of fatigue and generalized discomfort during pregnancy.
Exclusion Criteria:
High-risk pregnancy or obstetric complications (e.g., preeclampsia, placenta previa).
- History of neurological or musculoskeletal disorders unrelated to pregnancy.
- Any psychiatric disorder or currently taking sedative medications.
- History of uncontrolled diabetes mellitus or thyroid dysfunction.
- Participation in any structured exercise program or physiotherapy within the last 3 months.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:aerobic exercises
supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks
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Participants in Group A will receive supervised aerobic exercise in addition to conventional therapy.
Mode: Treadmill walking or stationary cycling (based on participant preference and safety).
Intensity: Moderate intensity at 50-60% of maximum heart rate (HRmax), calculated as HRmax = 220 - age.
Duration: 30 minutes per session.
Frequency: 3 sessions per week.
Total Duration: 8 weeks.
Monitoring: Heart rate monitors will be used to ensure target heart rate is maintained.
Each session will be supervised by a qualified physiotherapist.
Warm-up and Cool-down: 5-minute warm-up and 5-minute cool-down before and after each session.
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实验性的:progressive muscle relaxation
progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.
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Participants in Group B will receive supervised progressive muscle relaxation (PMR) in addition to conventional therapy. Muscle Groups: 16 major muscle groups will be targeted sequentially, including feet, calves, thighs, hips, abdomen, chest, arms, hands, shoulders, neck, jaw, eyes, forehead, and face. Technique: Each muscle group will be tensed for 5-7 seconds followed by relaxation for 20-30 seconds. Duration: 30 minutes per session. Frequency: 3 sessions per week. Total Duration: 8 weeks. Monitoring: Sessions will be conducted under supervision to ensure proper technique and participant comfort. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pittsburgh Sleep Quality Index
大体时间:8 weeks
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
This self-rated questionnaire evaluates sleep quality over a 1-month period.
It includes 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
These components are summed to yield a global PSQI score ranging from 0 to 21.
A score greater than 5 indicates poor sleep quality.
(39)
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8 weeks
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Fatigue Severity Scale
大体时间:8 weeks
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Fatigue levels will be assessed using the Fatigue Severity Scale (FSS). The scale includes 9 statements rated on a 7-point Likert scale, where higher scores indicate greater fatigue severity. The scale focuses on the impact of fatigue on motivation, exercise, physical functioning, and social life. |
8 weeks
|
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Numerical Pain Rating Scale
大体时间:8 weeks
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Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS), a scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will rate their average pain during the past week.
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8 weeks
|
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WHOQOL-BREF (Quality of Life)
大体时间:8 weeks
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Quality of life will be assessed using the WHOQOL-BREF questionnaire.
It consists of 26 items covering four domains: physical health, psychological health, social relationships, and environment.
Higher scores represent better quality of life.
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8 weeks
|
合作者和调查者
调查人员
- 首席研究员:Hafiza Iqra Rubab, MSWHPT、Riphah International University
出版物和有用的链接
一般刊物
- Mislu E, Assalfew B, Arage MW, Chane F, Hailu T, Tenaw LA, Kidie AA, Kumsa H. Prevalence and factors associated with restless legs syndrome among pregnant women in middle-income countries: a systematic review and meta-analysis. Front Med (Lausanne). 2023 Dec 21;10:1326337. doi: 10.3389/fmed.2023.1326337. eCollection 2023.
- Dewald-Kaufmann J, de Bruin E, Michael G. Cognitive Behavioral Therapy for Insomnia in School-Aged Children and Adolescents. Sleep Med Clin. 2022 Sep;17(3):355-365. doi: 10.1016/j.jsmc.2022.06.003.
- Luo Y, Du J, Wang J, Liu P, Shi Z, He Y, Che G, Huang K, Wang J. Progressive muscle relaxation alleviates anxiety and improves sleep quality among healthcare practitioners in a mobile cabin hospital: a pre-post comparative study in China. Front Psychol. 2024 Apr 30;15:1337318. doi: 10.3389/fpsyg.2024.1337318. eCollection 2024.
- Sweet L, O'Driscoll K, Blums T, Sommeling M, Kolar R, Teale G, Wynter K. Relationships are the key to a successful publicly funded homebirth program, a qualitative study. Women Birth. 2023 Jul;36(4):377-384. doi: 10.1016/j.wombi.2022.12.005. Epub 2023 Jan 4.
- Khan IA, Khan M, Raza F, Sheikh MLJMJoN. Enhancing Management of Restless Legs Syndrome through Complementary Physical Therapy: Toward Better Outcomes in a Distressing Sensorimotor Disorder. 2025;9(1):1-17.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- REC/RCR & AHS/25/0511
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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