Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Fall risk score
研究概览
简要总结
The disease burden of Diabetes Mellitus (DM) is growing rapidly, and multiple complications have been reported including cardiopulmonary and high fall risk which declines the overall quality of life. IMT can be useful technique to improve the physical and functional performance, reduce the severity of complications and enable the individuals to become active members of community. The current study is intended to evaluate the dual effects of IMT on postural stability and pulmonary function of diabetic patients.
详细描述
Diabetes Mellitus (DM) is a chronic metabolic disease characterized by hyperglycemia due to either deficiency of insulin or the inability of the body to utilize it. Hyperglycemia ultimately leads to multiple organ damage in patients with uncontrolled diabetes. The incidence occurs mostly at the age of 55 years equally affecting both genders. The prevalence of diabetes has been increased four times in the last three decades worldwide and global prevalence is increasing alarmingly with about 1 out of every 11 individuals having diabetes mellitus with 90% patients having type 2 diabetes mellitus. The statistical data depicts a huge burden of disease both in morbidity and mortality globally and an anticipated threat on health care system in future. (1) The complications of diabetes have been reported higher in the South Asia region as compared to western counterparts. In Pakistan, according to National Diabetes Survey of Pakistan (NDSP 2016 - 2017), the pooled prevalence of diabetes was projected to be 26.3% affecting 27.4 million people above 20 years of age. These high numbers are directly and indirectly linked with the economic burden on society and ultimately affect the quality of life of diabetics, families, and community.
Clinically, there are different complications (micro & macro vascular) associated with DM and these are main sources of morbidity and mortality. Neuropathy, nephropathy, and retinopathy are the microvascular complications whereas macrovascular complications include cardiovascular diseases, stroke as well as other vascular diseases. Apart from these complications, there are few other complications including decreased resistance to infections, dental issues, birth complications in gestational diabetes, poor balance, sarcopenia and increased risk of fall and fractures. The reduced strength and endurance of diaphragm the vital muscle of respiration lead to compromised respiratory functions.
Peripheral neuropathy, retinopathy and vestibular impairments alter the biomechanical stability and strength of postural control in individuals with DM. The instability generates disparity among muscular and neural structures to execute locomotion abilities, so abnormal gait pattern, weakness in lower limb musculature, impair sensory function, diminished reflexes and high fall risk have been observed.
These musculoskeletal complications compromise the mobility level and impede the performance of functional tasks and Activities of Daily Life (ADLs) in patients with DM. The limited movements and participation restrictions in social activities create inaccessibility and dependence on caregiver has been increased. The overall activity level has been declined and decreases the quality of life of individuals and ultimately developing social and economic burden on community.
Management of DM always emphases to improve the current health status and prevent further complications due to uncontrolled DM. Multiple management approaches have been reported in the literature to maintain adequate glycemic control and manage diabetes related complications and co morbidities. Treatment strategies also focus to maximize the quality of life and minimize the risk of treatment related complications including hypoglycemia. Balance and postural impairments are common in DM due to neuropathic changes and there are different training strategies have been documented in literature to improve postural stability and reduce fall risk. The training approaches include Tai Chi, Wii Fit based training, circuit training, strengthening exercises of lower limbs, gait training and task oriented dynamic training to enhance the overall balance abilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mini Mental State Examination (MMSE) score >24
- •Type II diabetes: Post 5-8 years diagnosis
- •Berg Balance score (30-40)
- •Presence of polyneuropathy confirmed through Modified Toronto Clinical Scoring System.
排除标准
- •Patients on oxygen therapy
- •Uncontrolled diabetes (Confirmed through HbA1C) or disease exacerbation in last 3 months.
- •Patients practicing regular physical activity, any balance training in the last 6 months and previous or current experience with IMT
- •Patients with musculoskeletal comorbidities that may impair exercise performance
- •Peripheral oxygen saturation (SpO2) < 90% during the Six-Minute Walk Test (6MWT)
- •Patients with long COVID syndrome
- •Hypertensive subjects without control medication as well as those presenting with a hypertensive peak (> 140/90 mmHg) for more than 3 consecutive days
- •Patients with cardiorespiratory diseases or patients taking drugs that effect balance e.g., beta blockers, anti-anxiety and anti-depressant drugs.
研究组 & 干预措施
Sham IMT
-
Standard exercise protocol according to ACSM's guidelines Standard exercise protocol according to ACSM's guidelines
-
Balance training - OEP
-
warm-up (10-15 min)
-
strengthening exercises (~20 min)
-
balance activities (~20 min)
-
cool-down (5-10 min) Balance training - OEP
-
warm-up (10-15 min)
-
strengthening exercises (~20 min)
-
balance activities (~20 min)
-
cool-down (5-10 min)
-
IMT through POWERBREATHE
-
30 quick breaths twice daily at an adjustable resistance (equivalent to ~50% of [baseline] MIP).
-
Will be increased up to 35 breaths as per patient's tolerance Sham IMT
-
60 slow breaths once daily at a load setting of 0 (corresponding to ~15% [baseline] MIP)
-
training load adjustment will be prevented using sticky tape applied to the device's load adjuster.
干预措施: Sham IMT (Device)
IMT group
-
Standard exercise protocol according to ACSM's guidelines Standard exercise protocol according to ACSM's guidelines
-
Balance training - Otago Exercise Program (OEP)
-
warm-up (10-15 min)
-
strengthening exercises (~20 min)
-
balance activities (~20 min)
-
cool-down (5-10 min) Balance training - OEP
-
warm-up (10-15 min)
-
strengthening exercises (~20 min)
-
balance activities (~20 min)
-
cool-down (5-10 min)
-
IMT through POWERBREATHE
-
30 quick breaths twice daily at an adjustable resistance (equivalent to ~50% of [baseline] MIP).
-
Will be increased up to 35 breaths as per patient's tolerance Sham IMT
-
60 slow breaths once daily at a load setting of 0 (corresponding to ~15% [baseline] MIP)
-
training load adjustment will be prevented using sticky tape applied to the device's load adjuster.
干预措施: Inspiratory Muscle Training (Device)
结局指标
主要结局
Fall risk score
时间窗: After 12 weeks of intervention
Fall risk score will be calculated by Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. Higher scores of fall risk score indicate greater balance deterioration and thus increase risk of fall. It would be assessed at baseline, after 12 weeks and after 6months of intervention.
Medial / lateral index
时间窗: After 12 weeks of intervention
Medial / lateral index will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.
Audit of Diabetes Dependent Quality of Life:
时间窗: After 12 weeks of intervention
Audit of Diabetes Dependent Quality of Life (ADDQOL) is a reliable questionnaire used to measure individual's perception of the impact of diabetes on their quality of life. The scales range from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Lower scores reflect poorer quality of life. It would be assessed ay baseline, after 12 weeks and after 6months of intervention.
Overall stability index
时间窗: After 12 weeks of intervention
Overall stability index will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.
Modified Clinical Test of Sensory Interaction in Balance (M - CTSIB) (composite score)
时间窗: After 12 weeks of intervention
Modified Clinical Test of Sensory Interaction in Balance (M - CTSIB) will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.
Anterior / Posterior index
时间窗: After 12 weeks of intervention
Anterior / Posterior index will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.
次要结局
- Sit up test(After 12 weeks of intervention)
- Six Minute Walk test (6MWT)(After 12 weeks of intervention)
- Forced expiratory volume in 1sec (FEV1)(After 12 weeks of intervention)
- Peak expiratory flow rate (PEFR)(After 12 weeks of intervention)
- Forced vital capacity (FVC)(After 12 weeks of intervention)
- FVC/FEV1(After 12 weeks of intervention)
- 30sec sit-to-stand (30secSTS)(After 12 weeks of intervention)
- Biering-Sørensen tests(After 12 weeks of intervention)
