Restless Leg SyndromeNCT07642089
Effects of Static Stretching and Strength Training on Antenatal Restless Leg Syndrome
A study testing Static Stretching and Static Stretching + Strength Training in people with Restless Leg Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Restless Legs Syndrome (RLS) is a prevalent sensorimotor disorder affecting pregnant women, particularly in the third trimester, and is associated with sleep disturbances, fatigue and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Restless Leg Syndrome
- What is being tested?
- Static Stretching and Static Stretching + Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Apr 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18-35 years.
- Gestational age between 24 and 32 weeks.
- Diagnosed with RLS based on the International Restless Legs Syndrome Study Group (IRLSSG) criteria.
- Experiencing sleep disturbances and fatigue related to RLS.
Who cannot join
- High-risk pregnancies or obstetric complications.
- Pre-existing neurological or musculoskeletal disorders.
- Engagement in regular exercise routines prior to the study.
- Contraindications to exercise as determined by a healthcare provider.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
National Hospital
Lahore, Punjab Province, 54000
Ghulam Fatima, PhD*, 03034073057
About this study
Official title: Effects of Statics Stretching With and Without Strength Training on Symptom Severity, Fatigue and Sleep Quality in Antenatal Restless Leg Syndrome
Restless Legs Syndrome (RLS) is a prevalent sensorimotor disorder affecting pregnant women, particularly in the third trimester, and is associated with sleep disturbances, fatigue and reduced quality of life. Non-pharmacological strategies such as stretching and strength training offer promising alternatives during pregnancy. This randomized controlled trial aims to compare the effects of static stretching alone and static stretching combined with strength training on sleep quality, symptom severity and fatigue in antenatal women with RLS.
Thirty pregnant women meeting the diagnostic criteria for RLS will be recruited from National Hospital and medical center and randomly assigned into two groups. Group A will receive static stretching exercises, while Group B will receive static stretching and lower limb strength training exercises for 6 weeks, three sessions per week. Data will be analyzed using SPSS, with a p-value < 0.05 considered statistically significant.
Read the detailed description
Restless Legs Syndrome (RLS) is a prevalent sensorimotor disorder affecting pregnant women, particularly in the third trimester and is associated with sleep disturbances, fatigue and reduced quality of life. Although pharmacological treatments are limited during pregnancy due to safety concerns, non-pharmacological strategies such as stretching and strength training offer promising alternatives. This randomized controlled trial aims to evaluate and compare the effects of static stretching alone and static stretching combined with strength training on sleep quality, symptom severity and fatigue in antenatal women diagnosed with RLS. A total of 30 pregnant women in their second or third trimester, meeting the diagnostic criteria for Restless Legs Syndrome (RLS), will be recruited for the study. The data will be collected from National Hospital and medical center and participants will be randomly assigned into two equal groups. Group A will receive a static stretching exercise regimen, while Group B will receive both static stretching and lower limb strength training exercises. The intervention will be carried out over a 6-week period, with three supervised sessions per week. Data will be analyzed using SPSS. Descriptive statistics will summarize demographic details. Paired t-tests or non-parametric tests will compare baseline and post-intervention scores using validated tools: IRLS-RS, PSQI, and FSS. A p-value < 0.05 will indicate statistical significance.
- Conditions
- Restless Leg Syndrome
- Being tested
- Static Stretching, Static Stretching + Strength Training
- Keywords
- Resistance training, Sleep quality, Muscle Stretching Exercise
- Medical subject headings
- Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static StretchingOther
Each session for Group A will begin with a brief warm-up consisting of five minutes of light walking, followed by static stretching of major lower limb muscles including the hamstrings, quadriceps, calf muscles, hip flexors, tibialis anterior, and lower back muscles. The hamstrings can be stretched by sitting or standing forward bends; the quadriceps can be extended by standing from heel to buttocks; and the calf muscles can be stretched by lunging against a wall.
Additionally, a kneeling lunge position will be used to stretch the hip flexors, and toe-point or sitting plantarflexion stretches will be used to target the tibialis anterior muscles. The Cat-Cow movement and Child's Pose will help increase lower back flexibility. Each stretch will be held for 20-30 seconds and repeated 2-3 times per muscle group.
Static Stretching + Strength TrainingOther
Group B will receive the same stretching protocol as Group A but will also engage in a structured strength training program targeting the lower limbs. Each strengthening exercise session will include seated ankle dorsiflexion using resistance bands to activate the tibialis anterior muscle, standing calf raises to strengthen the gastrocnemius and soleus muscles and glute bridges to target the gluteal and hamstring groups. Additionally, participants will perform wall squats to engage the quadriceps and core muscles in a low-impact manner, and seated leg extensions using resistance bands to strengthen the knee extensors. Each exercise will be performed in 2-3 sets of 10-12 repetitions, with 30-60 seconds rest between sets. Resistance bands will be used and progressively upgraded over the weeks based on individual tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Static Stretching) | Experimental | Group A will perform static stretching exercises targeting the lower limb muscles Receives: Other: Static Stretching |
| Group B (Static Stretching + Strength Training) | Active comparator | group B will perform the same static stretching exercises as Group A. along with that they will also engage in strength training exercises using resistance bands focusing on lower limb muscles. Receives: Other: Static Stretching + Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome Rating Scale (IRLS-RS)
The IRLS-RS is a 10-item self-reported questionnaire developed by the International Restless Legs Syndrome Study Group to assess the severity of RLS symptoms. Each item is rated on a 5-point Likert scale from 0 (no symptoms) to 4 (very severe symptoms), with a total possible score of 40.
Scores between 0-10 are classified as mild, 11-20 moderate, 21-30 severe, and 31-40 very severe RLS. The IRLS-RS has demonstrated strong internal consistency (Cronbach's α = 0.81) and interrater reliability (ICC = 0.87), making it suitable for use in antenatal populations.
Measured: 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire that measures seven domains of sleep, including sleep latency, duration, efficiency, disturbances, and daytime dysfunction. The total score ranges from 0 to 21, with scores above 5 indicating poor sleep quality. The PSQI is widely used in both clinical and research settings and has demonstrated strong psychometric properties, including a Cronbach's alpha of 0.83 and test retest reliability of 0.85. It is also validated for use in pregnant populations
Measured: 6 weeks
Fatigue Severity Scale (FSS)
Fatigue levels will be measured using the Fatigue Severity Scale (FSS), a 9-item instrument assessing the impact of fatigue on daily life. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), and the final score is the average of all items. A score of ≥4 indicates clinically significant fatigue. The FSS has high internal consistency (Cronbach's α ranging from 0.88 to 0.93) and has been validated in various populations, including pregnant and neurological patients.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start2 Apr 2025
- Primary completion2 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Restless Leg SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Javed, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642089
- Sponsor's protocol ID
- REC/RCR & AHS/25/0524
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krauthammer C, Klerman GL. Mania secondary to thyroid disease. Lancet. 1979 Apr 14;1(8120):827-8. doi: 10.1016/s0140-6736(79)91348-5. No abstract available.
PubMed 86073Brodsky L, Zuniga J. Nitrous oxide: a psychotogenic agent. Compr Psychiatry. 1975 Mar-Apr;16(2):185-8. doi: 10.1016/0010-440x(75)90065-6. No abstract available.
PubMed 1120420Freyschmidt J, Saure D, Hagemann G. [New intensifying screens in clinical radiology. II. Examinations in clinical practice]. Rofo. 1976 Sep;125(3):279-84. doi: 10.1055/s-0029-1230462. German.
PubMed 134959Cuttino JT, Scatliff JH. First year radiology residents: PGI vs. PGII. AJR Am J Roentgenol. 1979 May;132(5):855-6. doi: 10.2214/ajr.132.5.855. No abstract available.
PubMed 107768
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Statics Stretching With and Without Strength Training on Symptom Severity, Fatigue and Sleep Quality in Antenatal Restless Leg Syndrome
- ClinicalTrials.gov ID
- NCT07642089
- Acronym / sponsor ID
- REC/RCR & AHS/25/0524
- Conditions
- Restless Leg Syndrome
- Keywords
- Resistance training, Sleep quality, Muscle Stretching Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 2 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Restless Legs Syndrome (RLS) is a prevalent sensorimotor disorder affecting pregnant women, particularly in the third trimester, and is associated with sleep disturbances, fatigue and reduced quality of life. Non-pharmacological strategies such as stretching and strength training offer promising alternatives during pregnancy. This randomized controlled trial aims to compare the effects of static stretching alone and static stretching combined with strength training on sleep quality, symptom severity and fatigue in antenatal women with RLS.
Thirty pregnant women meeting the diagnostic criteria for RLS will be recruited from National Hospital and medical center and randomly assigned into two groups. Group A will receive static stretching exercises, while Group B will receive static stretching and lower limb strength training exercises for 6 weeks, three sessions per week. Data will be analyzed using SPSS, with a p-value < 0.05 considered statistically significant.
Detailed description
Restless Legs Syndrome (RLS) is a prevalent sensorimotor disorder affecting pregnant women, particularly in the third trimester and is associated with sleep disturbances, fatigue and reduced quality of life. Although pharmacological treatments are limited during pregnancy due to safety concerns, non-pharmacological strategies such as stretching and strength training offer promising alternatives. This randomized controlled trial aims to evaluate and compare the effects of static stretching alone and static stretching combined with strength training on sleep quality, symptom severity and fatigue in antenatal women diagnosed with RLS. A total of 30 pregnant women in their second or third trimester, meeting the diagnostic criteria for Restless Legs Syndrome (RLS), will be recruited for the study. The data will be collected from National Hospital and medical center and participants will be randomly assigned into two equal groups. Group A will receive a static stretching exercise regimen, while Group B will receive both static stretching and lower limb strength training exercises. The intervention will be carried out over a 6-week period, with three supervised sessions per week. Data will be analyzed using SPSS. Descriptive statistics will summarize demographic details. Paired t-tests or non-parametric tests will compare baseline and post-intervention scores using validated tools: IRLS-RS, PSQI, and FSS. A p-value < 0.05 will indicate statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Static Stretching) | Experimental | Other: Static StretchingGroup A will perform static stretching exercises targeting the lower limb muscles |
| Group B (Static Stretching + Strength Training) | Active comparator | Other: Static Stretching + Strength Traininggroup B will perform the same static stretching exercises as Group A. along with that they will also engage in strength training exercises using resistance bands focusing on lower limb muscles. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women aged 18-35 years.
- Gestational age between 24 and 32 weeks.
- Diagnosed with RLS based on the International Restless Legs Syndrome Study Group (IRLSSG) criteria.
- Experiencing sleep disturbances and fatigue related to RLS.
Key exclusion criteria (4 listed)
- High-risk pregnancies or obstetric complications.
- Pre-existing neurological or musculoskeletal disorders.
- Engagement in regular exercise routines prior to the study.
- Contraindications to exercise as determined by a healthcare provider.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static StretchingEach session for Group A will begin with a brief warm-up consisting of five minutes of light walking, followed by static stretching of major lower limb muscles including the hamstrings, quadriceps, calf muscles, hip flexors, tibialis anterior, and lower back muscles. The hamstrings can be stretched by sitting or standing forward bends; the quadriceps can be extended by standing from heel to buttocks; and the calf muscles can be stretched by lunging against a wall. Additionally, a kneeling lunge position will be used to stretch the hip flexors, and toe-point or sitting plantarflexion stretches will be used to target the tibialis anterior muscles. The Cat-Cow movement and Child's Pose will help increase lower back flexibility. Each stretch will be held for 20-30 seconds and repeated 2-3 times per muscle group. | Other | Group A (Static Stretching) |
| Static Stretching + Strength TrainingGroup B will receive the same stretching protocol as Group A but will also engage in a structured strength training program targeting the lower limbs. Each strengthening exercise session will include seated ankle dorsiflexion using resistance bands to activate the tibialis anterior muscle, standing calf raises to strengthen the gastrocnemius and soleus muscles and glute bridges to target the gluteal and hamstring groups. Additionally, participants will perform wall squats to engage the quadriceps and core muscles in a low-impact manner, and seated leg extensions using resistance bands to strengthen the knee extensors. Each exercise will be performed in 2-3 sets of 10-12 repetitions, with 30-60 seconds rest between sets. Resistance bands will be used and progressively upgraded over the weeks based on individual tolerance. | Other | Group B (Static Stretching + Strength Training) |
Primary outcome
International Restless Legs Syndrome Rating Scale (IRLS-RS)
Time frame: 6 weeks
The IRLS-RS is a 10-item self-reported questionnaire developed by the International Restless Legs Syndrome Study Group to assess the severity of RLS symptoms. Each item is rated on a 5-point Likert scale from 0 (no symptoms) to 4 (very severe symptoms), with a total possible score of 40. Scores between 0-10 are classified as mild, 11-20 moderate, 21-30 severe, and 31-40 very severe RLS. The IRLS-RS has demonstrated strong internal consistency (Cronbach's α = 0.81) and interrater reliability (ICC = 0.87), making it suitable for use in antenatal populations.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire that measures seven domains of sleep, including sleep latency, duration, efficiency, disturbances, and daytime dysfunction. The total score ranges from 0 to 21, with scores above 5 indicating poor sleep quality. The PSQI is widely used in both clinical and research settings and has demonstrated strong psychometric properties, including a Cronbach's alpha of 0.83 and test retest reliability of 0.85. It is also validated for use in pregnant populations
Fatigue Severity Scale (FSS)
Time frame: 6 weeks
Fatigue levels will be measured using the Fatigue Severity Scale (FSS), a 9-item instrument assessing the impact of fatigue on daily life. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), and the final score is the average of all items. A score of ≥4 indicates clinically significant fatigue. The FSS has high internal consistency (Cronbach's α ranging from 0.88 to 0.93) and has been validated in various populations, including pregnant and neurological patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 86073Krauthammer C, Klerman GL. Mania secondary to thyroid disease. Lancet. 1979 Apr 14;1(8120):827-8. doi: 10.1016/s0140-6736(79)91348-5. No abstract available.
- Background: PubMed 1120420Brodsky L, Zuniga J. Nitrous oxide: a psychotogenic agent. Compr Psychiatry. 1975 Mar-Apr;16(2):185-8. doi: 10.1016/0010-440x(75)90065-6. No abstract available.
- Background: PubMed 134959Freyschmidt J, Saure D, Hagemann G. [New intensifying screens in clinical radiology. II. Examinations in clinical practice]. Rofo. 1976 Sep;125(3):279-84. doi: 10.1055/s-0029-1230462. German.
- Background: PubMed 107768Cuttino JT, Scatliff JH. First year radiology residents: PGI vs. PGII. AJR Am J Roentgenol. 1979 May;132(5):855-6. doi: 10.2214/ajr.132.5.855. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatima Javed, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Stretching and Static Stretching + Strength Training in people with Restless Leg Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PHD* (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Legs Syndrome Rating Scale (IRLS-RS) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07642089, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.