EFFICACY OF MULTIMODAL EXERCISE INTERVENTION ON PAIN, BALANCE, SLEEP QUALITY, COGNITIVE FUNCTION, ANXIETY LEVELS AND OVERALL QUALITY OF LIFE FOR RESTLESS LEG SYNDROME IN INDIAN ELDERLY POPULATION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 2
研究概览
简要总结
Efficacy of multimodal exercise intervention on pain, balance, sleep quality, cognitive function, anxiety levels and overall quality of life for restless leg syndrome in Indian elderly population.
The study highlights that although exercise is known to improve sleep and well-being, research specific to Indian elderly with RLS is limited. Therefore, this research aims to determine whether a structured multimodal program—combining strengthening, aerobic training, stretching, balance exercises, foot massage, and relaxation—can improve pain, balance, sleep quality, cognitive function, anxiety levels, and overall quality of life.
This will be an experimental pre–post controlled study involving participants aged 65+ already diagnosed with RLS, screened using IRLSSG criteria and KPS. The intervention will run for 4 weeks with regular supervised exercise sessions. Outcomes will be assessed using validated tools such as International Restless Leg Syndrome Study Group Rating Scale (IRLS), Pittsburgh Sleep Quality Index (PSQI),Shor form McGill Pain Questionnaire(SF-MPQ), TUG and Berg balance Scale (BBS), Mini-Mental Scale Examination (MMSE), Hospital Anxiety and Depression Scale (HADS), SF 36, karnofsky Performance Status (KPS) Scale, etc.
The study expects that multimodal exercise will significantly reduce RLS symptoms and enhance functional, psychological, and sleep-related outcomes in the elderly population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 74.00 Year(s)（—）
- 性别
- All
入选标准
- •People who have already been diagnosed with restless leg syndrome (RLS) by a physician or doctor.
- •Screening criteria that meet all five of the International Restless Leg Syndrome Study Group Rating Scale (IRLS) Urge to Move the Legs.
- •Symptoms Triggered or Worsened by Rest/Inactivity.
- •Relief with Movement.
- •Worse in the Evening or Night.
- •Neither these symptoms nor those of other disorders are the primary markers of the sickness.
- •RLS symptoms at least once a week in the past 3 months.
- •By using the Karnofsky Performance Status (KPS) Scale on RLS in Elderly Individuals, included only those individual functional status and ability to perform daily activities Equal to or more than 70 percent.
- •Ability to walk for 3 meters distance.
排除标准
- •Exclusion Criteria: The person with uncontrolled hypertension.
- •The person with diagnosed with sleep apnea or with diabetes, cancer, heart failure or serious chronic disorder.
- •The person with any orthopedic, neurological, or other condition that might prevent them from safety completing exercise program Ongoing antipsychotic medication Recently diagnosed with renal disease, anemia, neuropathy, RA.
- •Patients diagnosed with Parkinson disease.
- •Pregnant women or within 6 months postpartum.
研究者
Loge Ngomle
SGT University, Gurugram, Haryana