Exergaming Versus Aerobic Exercises on Mild Cognitive Impairment

NCT04127448 | Completed

• 1 other identifier: Riphah IU Raana Ali
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Cognitive Impairment

Keywords

Aerobic Exercise; Cognitive dysfunction; Exergaming; T2DM.

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  The score were recorded for 6 weeks before the start of each session.

Other Outcomes (4)

• Change in Blood pressure in mm Hg from baseline to 6 week

  The score were recorded for 6 weeks before and after each session.

• Change in pulse rate in beats/min from baseline to 6 week

  The score were recorded for 6 weeks before and after each session.

• Change in oxygen saturation (O2 sat) in percentage from baseline to 6th week.

  The score were recorded for 6 weeks before and after each session.

Study Arms (2)

Exergaming Training Group

EXPERIMENTAL

Training was given using X-box 360 Kinect.

Other: Exergaming Training Group

Aerobic Exercise Group

ACTIVE COMPARATOR

Session using treadmill (model no TMX58 220).

Other: Aerobic Exercise Group

Interventions

Exergaming Training Group OTHER

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.

Exergaming Training Group

Aerobic Exercise Group OTHER

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).

Aerobic Exercise Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 46000, Pakistan

Location

Related Publications (16)

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• Meo 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.

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• Greenberg 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.

  PMID: 16470013 BACKGROUND

• Cukierman 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.

  PMID: 16283246 BACKGROUND

• Luchsinger 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.

  PMID: 22433668 BACKGROUND

• S 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.

  PMID: 19135149 BACKGROUND

• Roberts 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.

  PMID: 18695056 BACKGROUND

• Kodl 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.

  PMID: 18436709 BACKGROUND

• Awad 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.

  PMID: 15590460 BACKGROUND

• Kawamura 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.

  PMID: 24843599 BACKGROUND

• Diabetes 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.

  PMID: 12453955 BACKGROUND

• Colcombe 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.

  PMID: 12661673 BACKGROUND

• Suzuki 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.

  PMID: 23113898 BACKGROUND

• Nagamatsu 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.

  PMID: 22529236 BACKGROUND

• Rose 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.

  PMID: 15971974 BACKGROUND

• Corbetta D, Imeri F, Gatti R. Rehabilitation that incorporates virtual reality is more effective than standard rehabilitation for improving walking speed, balance and mobility after stroke: a systematic review. J Physiother. 2015 Jul;61(3):117-24. doi: 10.1016/j.jphys.2015.05.017. Epub 2015 Jun 18.

  PMID: 26093805 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Irum Yaqoob, MSNMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 15, 2019
• Study Start: March 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)