Comparative Effects of Aerobic and Muscle Relaxation Exercises in Pregnant Women With Restless Leg Syndrome
2026年6月4日 更新者：Riphah International University
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
This study will be a randomized controlled trial and will be conducted in the Gynecology and Physiotherapy departments of Valencia Health Clinic, Lahore.
Non-probability purposive sampling will be used to collect data.
A total of 40 pregnant women aged between 20-35 years, in their 2nd or 3rd trimester and clinically diagnosed with RLS, will be included after fulfilling inclusion and exclusion criteria and giving informed consent.
Subjects will be randomly divided into two groups using a random number generator table.
Group A will receive supervised aerobic exercises for 8 weeks while Group B will undergo progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.
Both groups will be assessed at baseline and after the 8-week intervention.
調査の概要
詳細な説明
Restless Legs Syndrome (RLS) is a neurological disorder that often worsens during pregnancy, particularly in the second and third trimesters.
It is characterized by an uncontrollable urge to move the legs, often accompanied by discomfort or pain, and is known to disrupt sleep, increase fatigue, and negatively affect the quality of life.
Pharmacological treatments for RLS during pregnancy are limited due to safety concerns, creating a need for effective, non-drug interventions.
Aerobic exercise and progressive muscle relaxation (PMR) are two physiotherapeutic approaches that have shown promise in improving sleep quality and reducing discomfort in various populations, but limited evidence exists regarding their impact on pregnant women with RLS.
This study will be a randomized controlled trial and will be conducted in the Gynecology and Physiotherapy departments of Valencia Health Clinic, Lahore.
Non-probability purposive sampling will be used to collect data.
A total of 40 pregnant women aged between 20-35 years, in their 2nd or 3rd trimester and clinically diagnosed with RLS, will be included after fulfilling inclusion and exclusion criteria and giving informed consent.
Subjects will be randomly divided into two groups using a random number generator table.
Group A will receive supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks.
Group B will undergo progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.
Both groups will be assessed at baseline and after the 8-week intervention.
Outcome measures will be evaluated using the Pittsburgh Sleep Quality Index (PSQI) for sleep, Fatigue Severity Scale (FSS), Visual Analogue Scale (VAS) for pain, and WHOQOL-BREF for quality of life.
Data analysis will be performed using SPSS version 26.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Imran Amjad, PhD
- 電話番号：03324390125
- メール：imran.amjad@riphah.edu.pk
研究場所
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、54770
- 募集
- Valencia health clinic
-
主任研究者：
- Sadia Gulzar, MSWHPT
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：aerobic exercises
supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks
|
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.
|
|
実験的：progressive muscle relaxation
progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pittsburgh Sleep Quality Index
時間枠：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)
|
8 weeks
|
|
Fatigue Severity Scale
時間枠：8 weeks
|
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
|
|
Numerical Pain Rating Scale
時間枠：8 weeks
|
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.
|
8 weeks
|
|
WHOQOL-BREF (Quality of Life)
時間枠：8 weeks
|
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.
|
8 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Hafiza Iqra Rubab, MSWHPT、Riphah International University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月1日
一次修了 (推定)
2026年7月1日
研究の完了 (推定)
2026年7月1日
試験登録日
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- REC/RCR & AHS/25/0511
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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