Type 2 DiabetesNCT04127448
Exergaming Versus Aerobic Exercises on Mild Cognitive Impairment
A study testing Exergaming Training Group and Aerobic Exercise Group in people with Type 2 Diabetes and Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes, Cognitive Impairment
- What is being tested?
- Exergaming Training Group and Aerobic Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2017to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Based Exercise Training v/s Aerobic Exercises on Cognitive Function in Adults With Type 2 Diabetes Mellitus.
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Cognitive Impairment
- Being tested
- Exergaming Training Group, Aerobic Exercise Group
- Keywords
- Aerobic Exercise, Cognitive dysfunction, Exergaming, T2DM.
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming Training GroupOther
Training was given using X-box 360 Kinect. Dr. Kawashima's brain and body exercise game comprising of multiple cognitive games out of which 4 selected games were played by the participants. These games were "Traffic control" (participants have to guide the colored cars into their matching colored tunnels by using their arms), "balloon buster" (players pop numbered balloons in order from the lowest to the highest), "pop till u drop", (match the color that appears on screen with the balloon of same color) and "strike a pose" (participant have to remember the poses shown and then copy them after few seconds). Games were played for 10 minutes initially then the duration was gradually increased to 30 minutes each session for 3 days/week and duration of 6 weeks. The session included 5-minute warm up, 20-minute interactive gaming, and 5-minute cool down.
Aerobic Exercise GroupOther
Session of 30-35 minutes, 3 days a week for 6 weeks was given using treadmill (model no TMX58 220). Time and intensity was gradually increased over the duration of 6 weeks. Starting from 10 minutes in 1st week, every 5 minutes was added to aerobics phase to each week until patient reached to 35 minutes in week 6 maintaining the intensity of 40-60% of heart rate reserve (%HRR).
| Study group | Role | What they receive |
|---|---|---|
| Exergaming Training Group | Experimental | Training was given using X-box 360 Kinect. Receives: Other: Exergaming Training Group |
| Aerobic Exercise Group | Active comparator | Session using treadmill (model no TMX58 220). Receives: Other: Aerobic Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Standardized Mini-mental State Examination (SMMSE) from baseline to 6th week.
Among diabetics it is an effective tool for the assessment of global cognition. It is a 30 points questionnaire with 20 separate tests. The twenty individual tests consist of eleven main areas of construction, writing, orientation, attention, registration, calculation, repetition, recalls. Scores of less then 25 are considered as person having impaired cognition.
Measured: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Change in Montreal cognitive assessment scale (MOCA, Urdu version) from baseline to 6th week.
It is a 30-point test administered in approximately 10 minutes. Thirty items assessing multiple cognitive domains include short-term memory, executive function, verbal ability, visuospatial abilities, sustained-attention task etc. The scores of less the 26 are considered to be abnormal.
Measured: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Change in Trail Making Test-A (TMT-A) from baseline to 6th week
Twenty-five circles are distributed over a piece of paper, and the circles enclose a number ranging from 1 to 25. Subjects are asked to connect the circles in numerical sequence as quickly and accurately as possible without lifting their pencil from the paper.
Measured: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Change in Trail Making Test-B (TMT-B) from baseline to 6th week
Trail making Test-B (TMT-B): There are 25 circles with numbers from 1 to 12 along with 12 Urdu alphabets in them. Participants are required to connect the circles in an alternating progressive sequence as quickly and accurately as possible without lifting their pencil from the paper. Trail-B is a pure test of assessing the executive functioning.
Measured: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Change in Verbal fluency test (VFT) from baseline to 6th week
It is a test to assess the verbal ability and executive control ability. It consists of 2 tasks: semantic fluency and phonemic fluency and the participants are given 1 min to produce as many unique words as possible within these categories. In semantic category participants have to produce name of objects for example fruits or animals. In phonemic words starting from a specific letter like 'f' are produced. The participant's score in each task is the number of unique correct words.
Measured: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Secondary outcomes (1)
Change in Random Blood sugar (RBS) from baseline to 6th week
Blood sugar (RBS) was measured using glucometer (ACCU-CHECK Performa, model= NC (mg/dl) Sr no: 68802207857) before each session.
Measured: The score were recorded for 6 weeks before the start of each session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Mar 2017
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irum Yaqoob, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127448
- Sponsor's protocol ID
- Riphah IU Raana Ali
- Status last verified
- Oct 2019
- First submitted
- 25 Sep 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015 Apr;33(2):97-111. doi: 10.2337/diaclin.33.2.97. No abstract available.
PubMed 25897193Meo SA, Zia I, Bukhari IA, Arain SA. Type 2 diabetes mellitus in Pakistan: Current prevalence and future forecast. J Pak Med Assoc. 2016 Dec;66(12):1637-1642.
PubMed 27924966Greenberg AS, Obin MS. Obesity and the role of adipose tissue in inflammation and metabolism. Am J Clin Nutr. 2006 Feb;83(2):461S-465S. doi: 10.1093/ajcn/83.2.461S.
PubMed 16470013Cukierman T, Gerstein HC, Williamson JD. Cognitive decline and dementia in diabetes--systematic overview of prospective observational studies. Diabetologia. 2005 Dec;48(12):2460-9. doi: 10.1007/s00125-005-0023-4. Epub 2005 Nov 8.
PubMed 16283246Luchsinger JA. Type 2 diabetes and cognitive impairment: linking mechanisms. J Alzheimers Dis. 2012;30 Suppl 2(0):S185-98. doi: 10.3233/JAD-2012-111433.
PubMed 22433668S Roriz-Filho J, Sa-Roriz TM, Rosset I, Camozzato AL, Santos AC, Chaves ML, Moriguti JC, Roriz-Cruz M. (Pre)diabetes, brain aging, and cognition. Biochim Biophys Acta. 2009 May;1792(5):432-43. doi: 10.1016/j.bbadis.2008.12.003. Epub 2008 Dec 16.
PubMed 19135149Roberts RO, Geda YE, Knopman DS, Christianson TJ, Pankratz VS, Boeve BF, Vella A, Rocca WA, Petersen RC. Association of duration and severity of diabetes mellitus with mild cognitive impairment. Arch Neurol. 2008 Aug;65(8):1066-73. doi: 10.1001/archneur.65.8.1066.
PubMed 18695056Kodl CT, Seaquist ER. Cognitive dysfunction and diabetes mellitus. Endocr Rev. 2008 Jun;29(4):494-511. doi: 10.1210/er.2007-0034. Epub 2008 Apr 24.
PubMed 18436709Awad N, Gagnon M, Messier C. The relationship between impaired glucose tolerance, type 2 diabetes, and cognitive function. J Clin Exp Neuropsychol. 2004 Nov;26(8):1044-80. doi: 10.1080/13803390490514875.
PubMed 15590460Kawamura T, Umemura T, Hotta N. Cognitive impairment in diabetic patients: Can diabetic control prevent cognitive decline? J Diabetes Investig. 2012 Oct 18;3(5):413-23. doi: 10.1111/j.2040-1124.2012.00234.x. Epub 2012 Aug 29.
PubMed 24843599Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
PubMed 12453955Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
PubMed 12661673Suzuki T, Shimada H, Makizako H, Doi T, Yoshida D, Tsutsumimoto K, Anan Y, Uemura K, Lee S, Park H. Effects of multicomponent exercise on cognitive function in older adults with amnestic mild cognitive impairment: a randomized controlled trial. BMC Neurol. 2012 Oct 31;12:128. doi: 10.1186/1471-2377-12-128.
PubMed 23113898Nagamatsu LS, Handy TC, Hsu CL, Voss M, Liu-Ambrose T. Resistance training promotes cognitive and functional brain plasticity in seniors with probable mild cognitive impairment. Arch Intern Med. 2012 Apr 23;172(8):666-8. doi: 10.1001/archinternmed.2012.379. No abstract available.
PubMed 22529236Rose FD, Brooks BM, Rizzo AA. Virtual reality in brain damage rehabilitation: review. Cyberpsychol Behav. 2005 Jun;8(3):241-62; discussion 263-71. doi: 10.1089/cpb.2005.8.241.
PubMed 15971974
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Based Exercise Training v/s Aerobic Exercises on Cognitive Function in Adults With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04127448
- Acronym / sponsor ID
- Riphah IU Raana Ali
- Conditions
- Type 2 Diabetes, Cognitive Impairment
- Keywords
- Aerobic Exercise, Cognitive dysfunction, Exergaming, T2DM.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming Training Group | Experimental | Other: Exergaming Training GroupTraining was given using X-box 360 Kinect. |
| Aerobic Exercise Group | Active comparator | Other: Aerobic Exercise GroupSession using treadmill (model no TMX58 220). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergaming Training GroupTraining was given using X-box 360 Kinect. Dr. Kawashima's brain and body exercise game comprising of multiple cognitive games out of which 4 selected games were played by the participants. These games were "Traffic control" (participants have to guide the colored cars into their matching colored tunnels by using their arms), "balloon buster" (players pop numbered balloons in order from the lowest to the highest), "pop till u drop", (match the color that appears on screen with the balloon of same color) and "strike a pose" (participant have to remember the poses shown and then copy them after few seconds). Games were played for 10 minutes initially then the duration was gradually increased to 30 minutes each session for 3 days/week and duration of 6 weeks. The session included 5-minute warm up, 20-minute interactive gaming, and 5-minute cool down. | Other | Exergaming Training Group |
| Aerobic Exercise GroupSession of 30-35 minutes, 3 days a week for 6 weeks was given using treadmill (model no TMX58 220). Time and intensity was gradually increased over the duration of 6 weeks. Starting from 10 minutes in 1st week, every 5 minutes was added to aerobics phase to each week until patient reached to 35 minutes in week 6 maintaining the intensity of 40-60% of heart rate reserve (%HRR). | Other | Aerobic Exercise Group |
Primary outcome
Change in Standardized Mini-mental State Examination (SMMSE) from baseline to 6th week.
Time frame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Among diabetics it is an effective tool for the assessment of global cognition. It is a 30 points questionnaire with 20 separate tests. The twenty individual tests consist of eleven main areas of construction, writing, orientation, attention, registration, calculation, repetition, recalls. Scores of less then 25 are considered as person having impaired cognition.
Change in Montreal cognitive assessment scale (MOCA, Urdu version) from baseline to 6th week.
Time frame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
It is a 30-point test administered in approximately 10 minutes. Thirty items assessing multiple cognitive domains include short-term memory, executive function, verbal ability, visuospatial abilities, sustained-attention task etc. The scores of less the 26 are considered to be abnormal.
Change in Trail Making Test-A (TMT-A) from baseline to 6th week
Time frame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Twenty-five circles are distributed over a piece of paper, and the circles enclose a number ranging from 1 to 25. Subjects are asked to connect the circles in numerical sequence as quickly and accurately as possible without lifting their pencil from the paper.
Change in Trail Making Test-B (TMT-B) from baseline to 6th week
Time frame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
Trail making Test-B (TMT-B): There are 25 circles with numbers from 1 to 12 along with 12 Urdu alphabets in them. Participants are required to connect the circles in an alternating progressive sequence as quickly and accurately as possible without lifting their pencil from the paper. Trail-B is a pure test of assessing the executive functioning.
Change in Verbal fluency test (VFT) from baseline to 6th week
Time frame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.
It is a test to assess the verbal ability and executive control ability. It consists of 2 tasks: semantic fluency and phonemic fluency and the participants are given 1 min to produce as many unique words as possible within these categories. In semantic category participants have to produce name of objects for example fruits or animals. In phonemic words starting from a specific letter like 'f' are produced. The participant's score in each task is the number of unique correct words.
1 secondary outcome
Change in Random Blood sugar (RBS) from baseline to 6th week
Time frame: The score were recorded for 6 weeks before the start of each session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 25897193American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015 Apr;33(2):97-111. doi: 10.2337/diaclin.33.2.97. No abstract available.
- Background: PubMed 27924966Meo SA, Zia I, Bukhari IA, Arain SA. Type 2 diabetes mellitus in Pakistan: Current prevalence and future forecast. J Pak Med Assoc. 2016 Dec;66(12):1637-1642.
- Background: PubMed 16470013Greenberg AS, Obin MS. Obesity and the role of adipose tissue in inflammation and metabolism. Am J Clin Nutr. 2006 Feb;83(2):461S-465S. doi: 10.1093/ajcn/83.2.461S.
- Background: PubMed 16283246Cukierman T, Gerstein HC, Williamson JD. Cognitive decline and dementia in diabetes--systematic overview of prospective observational studies. Diabetologia. 2005 Dec;48(12):2460-9. doi: 10.1007/s00125-005-0023-4. Epub 2005 Nov 8.
- Background: PubMed 22433668Luchsinger JA. Type 2 diabetes and cognitive impairment: linking mechanisms. J Alzheimers Dis. 2012;30 Suppl 2(0):S185-98. doi: 10.3233/JAD-2012-111433.
- Background: PubMed 19135149S Roriz-Filho J, Sa-Roriz TM, Rosset I, Camozzato AL, Santos AC, Chaves ML, Moriguti JC, Roriz-Cruz M. (Pre)diabetes, brain aging, and cognition. Biochim Biophys Acta. 2009 May;1792(5):432-43. doi: 10.1016/j.bbadis.2008.12.003. Epub 2008 Dec 16.
- Background: PubMed 18695056Roberts RO, Geda YE, Knopman DS, Christianson TJ, Pankratz VS, Boeve BF, Vella A, Rocca WA, Petersen RC. Association of duration and severity of diabetes mellitus with mild cognitive impairment. Arch Neurol. 2008 Aug;65(8):1066-73. doi: 10.1001/archneur.65.8.1066.
- Background: PubMed 18436709Kodl CT, Seaquist ER. Cognitive dysfunction and diabetes mellitus. Endocr Rev. 2008 Jun;29(4):494-511. doi: 10.1210/er.2007-0034. Epub 2008 Apr 24.
- Background: PubMed 15590460Awad N, Gagnon M, Messier C. The relationship between impaired glucose tolerance, type 2 diabetes, and cognitive function. J Clin Exp Neuropsychol. 2004 Nov;26(8):1044-80. doi: 10.1080/13803390490514875.
- Background: PubMed 24843599Kawamura T, Umemura T, Hotta N. Cognitive impairment in diabetic patients: Can diabetic control prevent cognitive decline? J Diabetes Investig. 2012 Oct 18;3(5):413-23. doi: 10.1111/j.2040-1124.2012.00234.x. Epub 2012 Aug 29.
- Background: PubMed 12453955Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
- Background: PubMed 12661673Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irum Yaqoob, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming Training Group and Aerobic Exercise Group in people with Type 2 Diabetes and Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Standardized Mini-mental State Examination (SMMSE) from baseline to 6th week. (time frame: The score were recorded at baseline before intervention start and at the 6th week i.e. at the end of intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127448, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.