Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes Mellitus Patients
Condition: Diabetes Mellitus
MeSH terms: Respiratory Aspiration; Diabetes Mellitus
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The central trunk stability and core strength are integral part of postural stability and
      balance but there is limited evidence to address these for balance training in DM. There is
      lacking evidence in literature on specific training targeting the central trunk and core
      strength to improve the balance ability, reduces fall risk and improve quality of life in DM
      patients.

      Inspiratory Muscle Training (IMT) is a device-based training and widely used therapeutic
      technique for improving inspiratory muscle strength and endurance, thoracic mobility,
      exercise capacity, reducing dyspnea and increasing quality of life. Recently, IMT has been
      used to improve balance and physical performance among elderly.

      How IMT is a useful intervention to improve cardiopulmonary function, postural control and
      quality of life? The underlying mechanism of IMT principal and clinical implications has
      three-fold mechanisms:

      First: Diaphragm thickness and strength enhances balance in two ways. Firstly, there is
      activation of diaphragm during upper limb movements indicating that the co-activation of
      diaphragm assists in the mechanical stabilization of the spine. Secondly, it plays a major
      role in the generation of intra-abdominal pressure which helps in the stabilization of lumbar
      spine during movements like shoulder abduction and adduction i.e., balance perturbations.
      These changes will improve the lower limb mobility, quadriceps strength, functional
      performance, postural control response and exercise tolerance among individuals. It creates
      an overall impact on enhanced balance strategies, physical performance and postural stability
      in elderly and other pathological conditions including chronic obstructive pulmonary disease
      (COPD), cystic fibrosis and stroke.

      Second: Increases in diaphragmatic mobility and hypertrophy as well as improved neural
      control and thickness of respiratory muscles including transversus abdominus and internal
      obliques leads to increase in exercise capacity, pulmonary function and decreased perceived
      breathlessness and exertion in the patients. It will increase the strength of respiratory
      muscles ultimately proving it to be an effective treatment strategy in COPD, chronic heart
      failure, multiple sclerosis and various respiratory diseases.

      Third: IMT exerts certain ergogenic effects through increasing diaphragmatic mobility and
      strength thereby improving the recovery time in sprinters, limiting cardiac sympathetic
      hyperactivity in cyclists and enhance rowing performance.

      Therefore, it can be hypothesized that IMT is not only effective for improving
      cardiopulmonary function but is also strongly linked with postural stability. The disease
      burden of 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.
    

Intervention name(s): Inspiratory Muscle Training; Sham IMT
Intervention type(s): Device; Device
Intervention description(s): Participants will perform home-based IMT twice daily [once in the morning (between 7:00 and 12:00 am) and once in the evening (between 16:00 and 21:00 pm)], for 8 consecutive weeks, using a mechanical pressure threshold loading device. In addition, participants in this group will try to increase the inspiratory resistance when the participants feel that 30 breaths are achievable with ease or if the participants could reach 35 consecutive breaths.; Participants will perform 60 slow breaths once daily at a load setting of 0 (corresponding to ~15% [baseline] MIP), using the same device as the IMT group. For the sham group, the ability to adjust the training load will be prevented using sticky tape applied to the device's load adjuster.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Balance; Diabetes Mellitus; Inspiratory Muscle Training; Quality of life