- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07628387
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
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Imran Amjad, PhD
- 전화번호: 03324390125
- 이메일: imran.amjad@riphah.edu.pk
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 54770
- 모병
- Valencia health clinic
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수석 연구원:
- Sadia Gulzar, MSWHPT
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pittsburgh Sleep Quality Index
기간: 8 weeks
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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
기간: 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
기간: 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)
기간: 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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hafiza Iqra Rubab, MSWHPT, Riphah International University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- REC/RCR & AHS/25/0511
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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-
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