Intensive Cognitive and Physical Rehabilitation Program

Completed

• Conditions: Cognitive Rehabilitation; Physical Rehabilitation
• Interventions: Behavioral: intensive cognitive physical rehabilitation program

• Registration Number: NCT02764905
• Lead Sponsor: Sheba Medical Center

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.

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 Timeline

• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2016-11
• Primary Completion: 2017-12
• Study Completion: 2018-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-27
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intensive cognitive-physical rehabilitation group	intensive cognitive physical rehabilitation program	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

Primary Outcome Measures

Name	Time	Method
change in A1C	3 months, 12 months	obtained from the results of routine lab tests conducted in the individual's respective health maintenance organization (HMO)

Secondary Outcome Measures

Name	Time	Method
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 quality of life (WHO-5 wellbeing questionnaire, the single general self- rated health question)

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Ramat-Gan, Israel