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Cognitive RehabilitationNCT02764905

Intensive Cognitive and Physical Rehabilitation Program

An observational study of Cognitive Rehabilitation and Physical Rehabilitation, run by Sheba Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 120 years
What is being tested?
intensive cognitive physical rehabilitation program
How many people
20 participants
Where
1 siteIsrael
Study dates
Nov 2016to May 2018
Phase
Observational
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 60 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: people with type 2 diabetes with below the norm cognitive function

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sheba medical center

    Ramat Gan

Other trials in Israel

About this study

Official title: A Comprehensive Intervention for Promoting Successful Aging Amongst Below the Cognitive Norm Older People With Diabetes- a Feasibility Study

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.

Read the detailed description

Intensive cognitive-physical rehabilitation intervention. The intervention will include two phases:

  1. Intensive phase: 12 weekly group meeting 4 hours each. Each meeting will be composed of:
  • 2 hours guided by a neuropsychologist each dedicated to a different cognitive domain for example memory, concentration, planning, information processing, problem solving (with special emphasis on diabetes issues). Each session will be composed of: 1) introduction- homework from previous session will be checked and the cognitive domain that will be discussed on that day will be introduced; 2) cognitive training using a computerized system (hour); 3) group discussion on compensatory strategies and training to be conducted at home
  • 2 hours guided by a certified physical trainer. These will include strength, balance and aerobic elements conducted in a group but individualized according to the capabilities and targets of the individual as assessed during the evaluation day. These sessions will also include formulation of a plan for exercise to be conducted by the individual on a daily basis. Additionally, 30 minutes of each session will be dedicated to psycho-education on various disease management aspects guided by a diabetes nurse educator or a dietitian (alternating).
  1. Consolidation phase: 9 months of monthly group meetings. The consolidation group sessions will include monthly 2 hour group discussions on challenges of implementation and coping strategies Medical surveillance will take place every 2 months with monitoring of glucose, blood pressure lipid control as well as follow-up on other recommendations given during the feed-back sessions this will be conducted by the Diabetes nurse educator who will be work together with a diabetes specialist an Endocrinologist (study physician) on maximal risk factor reduction.
Being tested
intensive cognitive physical rehabilitation program
Keywords
Diabetes, Cognitive-physical rehabilitation, Self care management
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intensive cognitive physical rehabilitation programBehavioural

    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.

Study groups in NCT02764905
Study groupRoleWhat they receive
intensive cognitive-physical rehabilitation groupwill 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
Receives: Behavioral: intensive cognitive physical rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in A1C

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

    Measured: 3 months, 12 months

Secondary outcomes (3)

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

    The 6 min walk test score

    Measured: 3 months, 12 months

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

    Grip strength using a Jammer dynamometer

    Measured: 3 months, 12 months

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

    Change in quality of life (WHO-5 wellbeing questionnaire, the single general self- rated health question)

    Measured: 3 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2017
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02764905
Sponsor's protocol ID
SHEBA-16-2953-TCY-CTIL
Status last verified
Oct 2019
First submitted
1 May 2016
Last updated
30 Oct 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 16283246

  • 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.

    PubMed 18207116

  • 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.

    PubMed 20799243

  • 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.

    PubMed 24622366

  • 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.

    PubMed 16424285

  • 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.

    PubMed 23100048

  • 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.

    PubMed 22374637

  • 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.

    PubMed 11106835

  • 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.

    PubMed 7555554

  • 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.

    PubMed 12435261

  • 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.

    PubMed 23428085

  • 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.

    PubMed 21392066

  • 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.

    PubMed 12422327

  • 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.

    PubMed 21969330

  • 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.

    PubMed 23269023

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Rehabilitation and Physical Rehabilitation, run by Sheba Medical Center at 1 site in Israel.

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 4 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 30 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 Israel. 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 A1C (time frame: 3 months, 12 months). 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 NCT02764905, which also lists 18 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 30 Oct 2019.

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