Intensive Cognitive and Physical Rehabilitation Program

October 27, 2019 updated by: Dr. Tali Cukierman-Yaffe, Sheba Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).
  2. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat-Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

people with type 2 diabetes with below the norm cognitive function

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in A1C
Time Frame: 3 months, 12 months
obtained from the results of routine lab tests conducted in the individual's respective health maintenance organization (HMO)
3 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months
Time Frame: 3 months, 12 months
The 6 min walk test score
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
Time Frame: 3 months, 12 months
Grip strength using a Jammer dynamometer
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
Time Frame: 3 months, 12 months
Change in quality of life (WHO-5 wellbeing questionnaire, the single general self- rated health question)
3 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tali Cukierman-yaffe, M.D, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHEBA-16-2953-TCY-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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