Intensive Cognitive and Physical Rehabilitation Program

NCT02764905 | Completed

• 1 other identifier: SHEBA-16-2953-TCY-CTIL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a feasibility study. Individuals that have undergone an evaluation day at the center for successful aging with diabetes with a Glycosylated hemoglobin (A1C) of \>=7.5 and a Montreal Cognitive Assessment (MoCA)\<26 will be approached and invited to participate. The participants will be divided into 2 groups: 1) information communication technology (ICT) group - an intervention based on weekly SMS that will remind the individual to implement his personal treatment plan and will raise the awareness to the importance of self-care in diabetes; 2) intensive cognitive-physical rehabilitation group that will include a 2 phase multi-disciplinary intervention. The 2 phases: a) Intensive phase: weekly 4 hour group meeting which will include computerized cognitive training, aerobic, balance and strength exercise and group discussion that will be dedicated to cognitive rehabilitation strategies development and implementation with emphasis on disease management and physical activity as well as psycho-education on various disease management aspects (medical and nutritional) b) a consolidation phase: monthly 2 hour group discussions on challenges of implementation and coping strategies. Outcomes will include change in A1C (primary), change in strength, aerobic capacity as well as quality of life and cognitive function (secondary). Additionally, team members and participants will fill out a structured questionnaire regarding their evaluation of the program aiming at refinement of the intervention.

Conditions

Cognitive Rehabilitation; Physical Rehabilitation

Keywords

Diabetes; Cognitive-physical rehabilitation; Self care management

Outcome Measures

Primary Outcomes (1)

• change in A1C

  obtained from the results of routine lab tests conducted in the individual's respective health maintenance organization (HMO)

  3 months, 12 months

Secondary Outcomes (3)

• change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months

  3 months, 12 months

• change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months

  3 months, 12 months

• change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months

  3 months, 12 months

Study Arms (1)

intensive cognitive-physical rehabilitation group

will include a 2 phase multi-disciplinary intervention. The 2 phases: a) Intensive phase: weekly 4 hour group meeting which will include computerized cognitive training, aerobic, balance and strength exercise and group discussion that will be dedicated to cognitive rehabilitation strategies development and implementation with emphasis on disease management and physical activity as well as psycho-education on various disease management aspects (medical and nutritional) b) a consolidation phase: monthly 2 hour group discussions on challenges of implementation and coping strategies

Behavioral: intensive cognitive physical rehabilitation program

Interventions

intensive cognitive physical rehabilitation program BEHAVIORAL

include 2 phases: a) Intensive phase: weekly 4 hour group meeting which will include computerized cognitive training, aerobic, balance and strength exercise and group discussion that will be dedicated to cognitive rehabilitation strategies development and implementation with emphasis on disease management and physical activity as well as psycho-education on various disease management aspects (medical and nutritional) b) a consolidation phase: monthly 2 hour group discussions on challenges of implementation and coping strategies.

intensive cognitive-physical rehabilitation group

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

people with type 2 diabetes with below the norm cognitive function

You may qualify if:

• Individuals with diabetes above the age of 65 and
• with a MoCA score of below 26
• with a A1C\>=7.5% .
• All the individuals will be Hebrew speaking without significant hearing or visual disability.

You may not qualify if:

• Diagnosed dementia or cognitive impairment
• Any major non-diabetes related illness expected to reduce life expectancy substantially or interfere with study participation and illiterate individuals to participate in the study.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

Location

Related Publications (18)

• 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

• Biessels GJ, Deary IJ, Ryan CM. Cognition and diabetes: a lifespan perspective. Lancet Neurol. 2008 Feb;7(2):184-90. doi: 10.1016/S1474-4422(08)70021-8.

  PMID: 18207116 BACKGROUND

• Reijmer YD, van den Berg E, Ruis C, Kappelle LJ, Biessels GJ. Cognitive dysfunction in patients with type 2 diabetes. Diabetes Metab Res Rev. 2010 Oct;26(7):507-19. doi: 10.1002/dmrr.1112.

  PMID: 20799243 BACKGROUND

• Exalto LG, Biessels GJ, Karter AJ, Huang ES, Katon WJ, Minkoff JR, Whitmer RA. Risk score for prediction of 10 year dementia risk in individuals with type 2 diabetes: a cohort study. Lancet Diabetes Endocrinol. 2013 Nov;1(3):183-90. doi: 10.1016/S2213-8587(13)70048-2. Epub 2013 Aug 20.

  PMID: 24622366 BACKGROUND

• Volpato S, Leveille SG, Blaum C, Fried LP, Guralnik JM. Risk factors for falls in older disabled women with diabetes: the women's health and aging study. J Gerontol A Biol Sci Med Sci. 2005 Dec;60(12):1539-45. doi: 10.1093/gerona/60.12.1539.

  PMID: 16424285 BACKGROUND

• Kirkman MS, Briscoe VJ, Clark N, Florez H, Haas LB, Halter JB, Huang ES, Korytkowski MT, Munshi MN, Odegard PS, Pratley RE, Swift CS. Diabetes in older adults. Diabetes Care. 2012 Dec;35(12):2650-64. doi: 10.2337/dc12-1801. Epub 2012 Oct 25. No abstract available.

  PMID: 23100048 BACKGROUND

• Punthakee Z, Miller ME, Launer LJ, Williamson JD, Lazar RM, Cukierman-Yaffee T, Seaquist ER, Ismail-Beigi F, Sullivan MD, Lovato LC, Bergenstal RM, Gerstein HC; ACCORD Group of Investigators; ACCORD-MIND Investigators. Poor cognitive function and risk of severe hypoglycemia in type 2 diabetes: post hoc epidemiologic analysis of the ACCORD trial. Diabetes Care. 2012 Apr;35(4):787-93. doi: 10.2337/dc11-1855. Epub 2012 Feb 28.

  PMID: 22374637 BACKGROUND

• Sinclair AJ, Girling AJ, Bayer AJ. Cognitive dysfunction in older subjects with diabetes mellitus: impact on diabetes self-management and use of care services. All Wales Research into Elderly (AWARE) Study. Diabetes Res Clin Pract. 2000 Dec;50(3):203-12. doi: 10.1016/s0168-8227(00)00195-9.

  PMID: 11106835 BACKGROUND

• Anderson RM, Funnell MM, Butler PM, Arnold MS, Fitzgerald JT, Feste CC. Patient empowerment. Results of a randomized controlled trial. Diabetes Care. 1995 Jul;18(7):943-9. doi: 10.2337/diacare.18.7.943.

  PMID: 7555554 BACKGROUND

• Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.

  PMID: 12435261 BACKGROUND

• Stellefson M, Dipnarine K, Stopka C. The chronic care model and diabetes management in US primary care settings: a systematic review. Prev Chronic Dis. 2013;10:E26. doi: 10.5888/pcd10.120180.

  PMID: 23428085 BACKGROUND

• Liang X, Wang Q, Yang X, Cao J, Chen J, Mo X, Huang J, Wang L, Gu D. Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. Diabet Med. 2011 Apr;28(4):455-63. doi: 10.1111/j.1464-5491.2010.03180.x.

  PMID: 21392066 BACKGROUND

• Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.

  PMID: 12422327 BACKGROUND

• Ropponen A, Silventoinen K, Tynelius P, Rasmussen F. Association between hand grip/body weight ratio and disability pension due to musculoskeletal disorders: a population-based cohort study of 1 million Swedish men. Scand J Public Health. 2011 Dec;39(8):830-8. doi: 10.1177/1403494811424610. Epub 2011 Oct 3.

  PMID: 21969330 BACKGROUND

• Yoshida H, Nishi M, Watanabe N, Fujiwara Y, Fukaya T, Ogawa K, Kim MJ, Lee S, Shinkai S. [Predictors of frailty development in a general population of older adults in Japan using the Frailty Index for Japanese elderly patients]. Nihon Ronen Igakkai Zasshi. 2012;49(4):442-8. doi: 10.3143/geriatrics.49.442. Japanese.

  PMID: 23269023 BACKGROUND

• Hajos TR, Pouwer F, Skovlund SE, Den Oudsten BL, Geelhoed-Duijvestijn PH, Tack CJ, Snoek FJ. Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus. Diabet Med. 2013 Feb;30(2):e63-9. doi: 10.1111/dme.12040.

  PMID: 23072401 BACKGROUND

• DeSalvo KB, Bloser N, Reynolds K, He J, Muntner P. Mortality prediction with a single general self-rated health question. A meta-analysis. J Gen Intern Med. 2006 Mar;21(3):267-75. doi: 10.1111/j.1525-1497.2005.00291.x. Epub 2005 Dec 7.

  PMID: 16336622 BACKGROUND

• Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.

  PMID: 26822328 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tali Cukierman-yaffe, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 6, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

IL (1)