Clinical trial NCT04127448: Exergaming Versus Aerobic Exercises on Mild Cognitive Impairment
Official title: Effect of Virtual Reality Based Exercise Training v/s Aerobic Exercises on Cognitive Function in Adults With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Cognitive Impairment
Keywords: Aerobic Exercise
Cognitive dysfunction
Exergaming
T2DM.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ain to this study was to determine the effects of Exergaming and Aerobic exercise on mild cognitive impairment (MCI) and random blood sugar levels (RBS) in adults with type 2 diabetes mellitus (T2DM) and to compare the effects between both treatments.This Randomized Control Trial (RCT) enrolled 33 diabetics to Aerobic group (AG) (n=18) and Exergaming training group (ER) (n=15) who completed the six weeks of aerobics or ER training. Aerobic group followed intervention using treadmill for 30 mins/day for 3 days/week maintaining intensity of 40-60% heart rate reserve (HRR). The ER group did physical activity using X-box 360 for 30 mins/day, 3 days/week. The cognitive testing included MMSE, MOCA, Trail-A/B and verbal fluency test (VF). The random blood sugar levels (RBS) of the participants were also monitored. Data was analyzed on IBM SPSS Statistics 20.

Detailed description: The American Diabetes Association define diabetes as a metabolic disorder characterized by decreased production of insulin and/or the development of insulin resistance which results in hyperglycemia. The most common types of DM are type 1 and type 2. Type 2 diabetes mellitus (T2DM) is more commonly observed in adults and represents 90-95% cases worldwide. According to WHO, Pakistan is ranked 7th among countries with high prevalence rate of T2DM. A review done in December 2016 stated that the prevalence rate of T2DM in Pakistan is 11.77%. (Males =11.20% /females=9.19%).

Diabetes mellitus is found to be associated with a vast majority of co-morbidities that have devastating impact on the health and quality of life of the patients. Among diabetics the development of cardiovascular dysfunctions is a well known cause of mortality and morbidity. Around 80% diabetic populations develop the metabolic syndrome, characterized by the development of insulin resistance along with hypertension, Dyslipidemia and visceral obesity. Obesity is very commonly observed among diabetics and the occurrence of visceral adiposity contributes to the increment of the pathogenesis of insulin resistance. Other co-morbidities associated with diabetes are diabetic retinopathy, neuropathy, nephropathy, psychosocial impairments and cognitive dysfunction.

It is well known that diabetes mellitus is found to be associated with many co-morbidities. Recent evidences show that it is also a risk factor for the development of cognitive impairment. Studies show that diabetics have a 1.2- to 1.5-fold greater rate of developing decline in cognitive function compared to those without diabetes. A 15 year follow up study done in Japan in 2011 also reported increased prevalence of dementia among the diabetics. It is becoming evident that diabetes affects the nervous system causing diabetic encephalopathy which results in the neuronal damage and loss contributing to cognitive dysfunction. A review published in 2009 stated that mild to moderate cognitive declines were observed among diabetics. Reduced performance was observed on the tests of multiple cognitive domains including episodic memory, information processing speeds and task executive functioning. A little decline was also observed on the tests concerning mental flexibility. It is becoming evident from the data of epidemiological studies that there is strong association between diabetes and increased risk of pathological changes in central nervous system resulting in cognitive dysfunction and later on developing into dementia. A review states that it is evident from the neurocognitive testing that cognitive decline should be listed among the many diabetes associated complications. The factors like the end organ damage influenced by hyperglycemia, vascular and neuronal damage, hypoglycemia and the presence of amyloid lesions may be held responsible for the changes and damages to cerebral structure. Literature shows that cognitive dysfunction is also related with the diabetes associated co-morbidities including Increased obesity, Low muscle mass, depression, cardiovascular diseases, chronic inflammation and cerebrovascular diseases.

Diet and exercise represent the initial treatment approaches in clinical practice to slow progression of metabolic disturbance associated with prediabetes and to assist with pharmacological treatment in established T2DM. Increased physical activity has clear beneficial physiological effects for older adults with T2DM or glucose intolerance or insulin resistance and more recently has been shown to benefit cognition as well.Epidemiological evidence consistently links physical exercise with better cognitive performance, lower risks for dementia, and reduced pathological changes in the central nervous system (CNS). Experimental studies have also reported benefits of aerobic and resistance training on cognitive function in older adults.

The trend towards using the virtual reality as a platform for rehabilitation among many neurological deficits is increasing tremendously. Researches show that VR training may be helpful in improving the physical, cognitive and emotional impairments faced by the patients experiencing some neurological deficit. It has been seen that when patients following brain insult after stroke are involved in VR related rehabilitation programs their functional performance was improved. The improvements were seen in balance, walking speeds and mobility.

Although no trials have been done to our knowledge concerning the use of virtual reality and cognitive dysfunctions in adults with T2DM but a variety of researches indicate that VR can be useful in treating cognitive impairments. Undoubtedly VR training has potential to simulate many real life or imaginary situations, hence providing the platform for more valid and dynamic assessment and training. It also provides a constant environment with the prospective for multiple repetitions of the same task to be assessed. Furthermore in contrast to many conventional methods, VR-based assessment and training provides accurate performance measurements and exact replays of task performance. Currently VR is being used as a supportive intervention after brain damage to deal with multiple aspects of cognitive impairments including memory impairment, executive dysfunctions, visio-spatial and attention deficit. The use of VR brain damage rehabilitation is exceedingly expanding and will become an important part of cognitive assessment and rehabilitation in future. Studies also show VR as a beneficial tool for treating anxiety disorders.

Eligibility criteria: Inclusion Criteria:

* subjects scoring \<25 on MMSE
* subjects being treated with diet alone, oral medications, insulin or combination at the time of enrolment, without recent changes in medication (\<3 months)
* sedentary adults (self-reporting of \< 30 min of structured physical activity for \< 3 times/week during last 6 months)

Exclusion Criteria:

* if they had any co-morbidity that presented contraindications to moderate to vigorous type of physical activity.
* Subjects with any unstable chronic diseases or significant cognitive impairment (diagnosed dementia) were also excluded.

Primary outcomes:
measure: Change in Standardized Mini-mental State Examination (SMMSE) from baseline to 6th week.
timeFrame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
measure: Change in Montreal cognitive assessment scale (MOCA, Urdu version) from baseline to 6th week.
timeFrame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
measure: Change in Trail Making Test-A (TMT-A) from baseline to 6th week
timeFrame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
measure: Change in Trail Making Test-B (TMT-B) from baseline to 6th week
timeFrame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
measure: Change in Verbal fluency test (VFT) from baseline to 6th week
timeFrame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Secondary outcomes:
measure: Change in Random Blood sugar (RBS) from baseline to 6th week
timeFrame: The score were recorded for 6 weeks before the start of each session.
Other outcomes:
measure: Change in Blood pressure in mm Hg from baseline to 6 week
timeFrame: The score were recorded for 6 weeks before and after each session.
measure: Change in pulse rate in beats/min from baseline to 6 week
timeFrame: The score were recorded for 6 weeks before and after each session.
measure: Change in oxygen saturation (O2 sat) in percentage from baseline to 6th week.
timeFrame: The score were recorded for 6 weeks before and after each session.
measure: Change in respiratory rate in breaths/min from baseline to 6th week.
timeFrame: The score were recorded for 6 weeks before and after each session.
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Irum Yaqoob, MSNMPT
role: PRINCIPAL_INVESTIGATOR
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