An interventional study of stretching and novel exercises and novel exercises in Restless Leg Syndrome, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
Restless leg syndrome is a sensorimotor condition .It usually affects more women than in males. Typically the symptoms arise during periods of inactivity and improve with movement. It is assumed to be related to hormonal changes that occur during pregnancy, occurs during 3rd trimester of pregnant female. Progressive muscle relaxation exercise reduces the severity of RLS symptoms and enhances the sleep and quality of life. The aim of this study is to determine the combined effects of novel exercise and stretching exercise on Sleep, Quality of Life and pain in pregnant females with restless leg syndrome.
The study will be randomized control trial and will be conducted in Bashir medical complex and Shahdeen hospital Gujranwala. Non-probability convenience sampling technique will be used and 44 participants of pregnant females will be recruited in study after It will be a single-blinded study in which the assessor will be blinded and will assess the patients and measure the outcomes. Data will be collected from pregnant women aged between 18 and 40 years, with a gestational period of 27 to 34 weeks, who are clinically diagnosed with Restless Leg Syndrome. Participants will be randomly assigned into two groups: Group A (Experimental), which combines Stretching Exercise and Novel Exercise. Group B (Control group) only Perform Novel Exercise Each exercise of the Duration is 8 weeks ,Frequency: 3-5 sessions per week (30-45 minutes/session)The baseline treatment included Myofascial Massage, Thermotherapy, Compressive socks, Acupuncture Participants were advised to apply hot and cold water to their legs before bedtime for seven days. Apply compression stockings when they got up in the morning for 3 weeks and took them off at bedtime. Massage and acupressure reduced the severity of restless legs syndrome The subjects will be divided into two groups.
. Group A (Experimental group) Perform combine stretching exercise and novel exercise on each 22 pregnant women with restless leg syndrome Stretching exercises are calf muscle stretch, hamstring stretch and quadriceps stretch front thigh, hip flexor stretches, and ankle rotations. The duration of each stretch is 20 to 30 seconds holds repetition two to three times per session. Each session performs at least 15 to 20 minutes. Repetition 10 times more and other hand Novel exercise includes Ankle Pronation and supination, Calf Raises, Leg lifts, ankle pumps, quadriceps exercise, wall squat etc. Duration of exercise Includes both stretching and novel exercises (each 15-20 minutes) three days per week. Group B (Control group) perform Novel exercise on each 22 pregnant women. The tool will be used for restless leg syndrome, sleep, quality of life is RLS intensity Scale, Numeric Pain rating scale, SF-12 Quality of life. Data will be analyzed by IBMM SPSS version 25.
259 studies on the registry are indexed under Restless Legs Syndrome; 38 are open to participants now.
This study's enrollment of 44 is below the median of 53 across 200 interventional studies indexed under Restless Legs Syndrome.
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The following rules will be followed for the inclusion of participants in the study:
Exclusion Criteria:
The following rules will exclude some patients from this study:
COMBINE stretching exercises and novel exercises
Other: stretching and novel exercises
novel exercises
Other: novel exercises
Perform combine stretching exercise and novel exercise on each 22 pregnant women with restless leg syndrome Stretching exercises are calf muscle stretch, hamstring stretch and quadriceps stretch front thigh, hip flexor stretches, and ankle rotations. The duration of each stretch is 20 to 30 seconds holds repetition two to three times per session. Each session performs at least 15 to 20 minutes. Repetition 10 times more and other hand Novel exercise includes Ankle Pronation and supination, Calf Raises, Leg lifts, ankle pumps, quadriceps exercise, wall squat etc. Duration of exercise Includes both stretching and novel exercises (each 15-20 minutes) three days per week.
Novel exercise on each 22 pregnant women. The tool will be used for restless leg syndrome, sleep, quality of life is RLS intensity Scale, Numeric Pain rating scale, SF-12 Quality of life.
NUMERIC PAIN RATING SCALE
This tool is used to measure the pain intensity in individuals. It has eleven-point numeric scale ranges from zero to ten. If zero is no pain, then ten is severe pain. It has four levels to assess the pain quality: 0 is considered as no pain, one to 3 is considered as minor pain, four to six is moderate pain, and seven to 10 is considered as severe pain
Time frame: 6 weeks
QUALITY OF LIFE SCALE -SHORT FORM-12
SF-12 has 12 different items composed of eight separate headings consisting of subdivisions such as limitations related to physical restrictions, physical performance, ache vitality, emotional issues difficulty, social performance and mental wellness. It has two scores: the physical component summary score (PCS12) and the mental component summary score (MCS12. include general health physical functioning role physical and pain.
Time frame: 6 weeks
GRONINGEN SLEEP QUALITY SCALE
The Participant sleep routines and general quality of sleep are evaluated by using this measure. It has fifteen items with true or false values. All true things received one point, with the expectation of items eight, ten,\& twelve which had scores that were inverted .This scale scoring method is scores ranges from zero to fourteen 14 with the first question not being part of final value. It has three categories were created based on the total value normal refreshing sleep (score 0 to 2), slightly disturbed sleep" (value 3-9), \& poor quality of Sleep (10 to 14) significance
Time frame: 6 weeks
RESTLESS LEG SYNDROME RATING SCALE
It is a gold standard Scale. Each have ten questions on the test has a grade ranging from 0 to 4. The last five questions evaluate how affects the RLS on daily living activities or quality of life, while the first five questions should concentrate on the intensity of symptoms. The severity of disease is reflected in the total score. 40 are the highest possible score. Mild (1-10), moderate (11-20), severe (21-30), and extremely severe (31-40) are the total RLS severity scores significance
Time frame: 6 weeks
Plan to share: No
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Ran from Sep 2025 to primary completion in Feb 2026, 4 months.
Of 46 non-industry interventional studies with no phase under Restless Legs Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 42. This study's 4 months is below that.
Counting every sponsor, half of 53 studies reached it within 12 months; a quarter within 5 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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