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Lifestyle, Exercise and Diet: The LEAD Study (LEAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056508
Recruitment Status : Terminated (Due to COVID-19, recruitment and enrollment was suspended and never resumed. COVID-related changes have been made to the clinical program which houses our intervention, and we could not compare new participants with our previous cohort.)
First Posted : February 17, 2017
Last Update Posted : October 14, 2020
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Toronto Rehabilitation Institute
The Centre for Memory and Aging
University of Waterloo
Information provided by (Responsible Party):
Carol Greenwood, Rotman Research Institute at Baycrest

Tracking Information
First Submitted Date  ICMJE February 9, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE July 1, 2018
Actual Primary Completion Date October 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Changes from baseline brain structure at 6 months and 12 months. [ Time Frame: 6 months plus 6 month follow-up ]
Cortical and subcortical grey matter density using MRI three-dimensional T1 weighted structural scan (MPRAGE)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Changes from baseline cerebral blood flow at 6 months and 12 months. [ Time Frame: 6 months plus 6 month follow-up ]
    Pseudo-continuous arterial spin labeling MRI (pcASL) to quantify cerebral blood flow
  • Changes from baseline cognition at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    pen and paper and computerized tasks, monitoring memory, executive function, and speed of processing. The results will be presented as a composite score of total neuro-psychological performance aggregating scores from the above cognitive domains.
  • Changes from baseline brain activity related to attention at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    BOLD functional MRI while participants performing an attention task
  • Changes from baseline resting state connectivity at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    BOLD functional MRI while participants at rest
  • Changes from baseline diet quality at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    Principle component analyses based on Canadian Diet History Questionnaire II (C-DHQII)
  • Changes from baseline adherence to diet recommendations at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    Principle component analyses based on the Eating Pattern Self-Assessment
  • Changes from baseline grip strength at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    Grip strength using a hand held dynamometer
  • Changes from baseline gait performance at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    Gait velocity, stride length/width, and associated variability assessed using a GAITRite pressure sensor mat.
  • Changes from baseline balance performance at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    Posturography assessment on balance platform
  • Changes from baseline maximal oxygen uptake at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    VO2max determined during cardiopulmonary assessment
  • Changes from baseline blood moderators at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    e.g. BDNF, pro-BDNF, ApoE,
  • Changes from baseline HbA1C at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    HbA1C
  • Changes from baseline fasting glucose at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    fasting glucose
  • Changes from baseline insulin levels at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    insulin
  • Changes from baseline lipid levels at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    lipid profile
  • Changes from baseline homocysteine levels at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    homocysteine
  • Changes from baseline C reactive protein levels at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    CRP
  • Changes from baseline TNF-alpha levels at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    TNF-alpha
  • Changes from baseline IL6 levels at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    IL6
  • Changes from baseline vitamin K levels at 6 months and 12 months [ Time Frame: 6 months plus 6 month follow-up ]
    Vitamin K
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle, Exercise and Diet: The LEAD Study
Official Title  ICMJE Nutrition, Exercise and Lifestyle: Team 6 of the Canadian Consortium on Neurodegeneration in Aging (CCNA)
Brief Summary This study will explore the impact of an exercise and nutrition (EX+NUTR) , relative to exercise alone (EX) intervention, on brain structure and function as well as blood biomarkers in older adults with subjective cognitive decline (SCD) and vascular risk factors. The overall hypotheses are that a combined EX+NUTR, relative to EX, intervention will evoke more positive changes in brain structure (e.g. hippocampal volume), neural activity (e.g. task associated functional activations monitored through fMRI), and cognitive performance. These changes will be associated with an improved metabolic profile, reductions in inflammatory cytokines and oxidative burden, and greater intervention compliance.
Detailed Description All participants will engage in group supervised exercise sessions once per week as well as engage in additional exercise sessions at home 4 days/week. The exercise program will be run out of two sites (Toronto Rehabilitation Institute (TRI) - Rumsey Centre in Toronto, and the Centre for Community, Clinical Applied Research Excellence (CCCARE) at the University of Waterloo). The supervised exercise sessions modeled after the standard TRI Cardiovascular Prevention and Rehabilitation program, including aerobic training, resistance training and education/counseling. The active group will receive strategy training to simultaneously improve their diet in conjunction with our newly developed Brain Health Food Guide (EX+BHFG); the placebo control group (EX+BHEd) will receive brain health education to control for time and social participation. [NOTE All participants must also be enrolled in the SCD cohort of the CCNA and undergo the CCNA's COMPASS-ND assessment at the beginning of the trial.] The study is 6 months in duration and requires participants to attend 2.5 hr weekly sessions (1 hr supervised exercise, 0.5 hr exercise/stress education and 1 hr nutrition or brain health education) and to exercise on their own an additional 3-4 times per week. Participants are assessed on measures of cognition, brain health (MRI), functional status at baseline, post intervention and 6 month follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Subjective Cognitive Decline
  • Age-Related Cognitive Decline
Intervention  ICMJE
  • Behavioral: Exercise plus nutrition
    On the same day as the exercise class, participants will also receive nutrition support. Participants will alter their overall diet to be consistent with recommendations outlined in our brain health food guide (BHFG) and receive diet counseling and strategy training to promote retention and enable this dietary change. For the first two months, diet group sessions will be held on a weekly basis. For the remaining four months, sessions will be divided between group sessions and individual meetings with study dietitians, on a predefined schedule. Participants will submit weekly logs outlining diet goals, plans, successes and obstacles to help direct identification of sequential goals.
  • Behavioral: Exercise
    Supervised group exercise will be performed once per week (60 minutes) and self-directed exercise (4 additional aerobic and 2-3 resistance training sessions per week) will be monitored by an exercise diary. The initial walking prescription will be set at ~1.6 km and an intensity equivalent to the anaerobic threshold and/or 60% VO2-peak. Progressions will be made every 2 weeks, increasing distance to a maximum of 6.4 km and then increasing to a max intensity of 80% of VO2-peak and/or max duration of 60 minutes. Heart rate and perceived exertion will be monitored. The program will last 6 months.
Study Arms  ICMJE
  • Experimental: Exercise plus Nutrition
    6 months of supervised group exercise plus education and strategy training to alter diet to be consistent with recommendations outlined in our brain health food guide (BHFG).
    Intervention: Behavioral: Exercise plus nutrition
  • Active Comparator: Exercise
    Identical exercise to the experimental plus education and passive discussion about brain health and healthy lifestyle to control for experimental group nutrition sessions.
    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 9, 2020)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
66
Actual Study Completion Date  ICMJE October 8, 2020
Actual Primary Completion Date October 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • meeting criteria for subjective cognitive impairment (1 through 5 below)

    1. Answer Yes to both following questions:

      1. Do you feel like your memory or thinking is becoming worse?
      2. Does this concern you?
    2. Have a delayed recall score on 1 paragraph of the Logical Memory test (Wechsler Memory Scale, maximum score 25) above the education-adjusted cut-offs:

      • ≥9 for 16+ years of education;
      • ≥5 for 8-15 years of education;
      • ≥3 for 0-7 years of education.
    3. Have a Montreal Cognitive Assessment (MoCA) total score of 20 and over (≥20/30).
    4. Have a delayed recall score on the CERAD word list of 5 and over (≥5).
    5. Have a global Clinical Dementia Rating score (CDR) equal to 0.5 or less (≤0.5).
  • ≥2 vascular risk factors (overweight (BMI>25), T2DM, hypercholesterolemia or hypertension),
  • Consuming a poor quality diet (at least median or below on number of servings of vegetable, fruit, fish and nuts based on Canadian consumption patterns in older adults)
  • Reasonably sedentary (less than 75min per week of moderate - vigorous intensity physical activity)
  • Be available for the whole intervention (6 months) and a 12- month follow-up visit
  • English speaking

Exclusion Criteria:

  • The presence of significant known chronic brain disease such as: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, malignant tumors, Parkinson's disease, and other rarer brain illnesses.
  • Ongoing alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
  • Subject does not have a study partner who can provide corroborative information.
  • Symptomatic stroke within the previous year.
  • Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure.
  • Major surgery within last 2 months.
  • History of intracranial surgery
  • Serious comorbid condition that, in the opinion of the study investigator, is likely to result in death within a year.
  • High performance athletes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056508
Other Study ID Numbers  ICMJE CCNA-NELT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: data will be uploaded to shared CCNA database - LORIS
Responsible Party Carol Greenwood, Rotman Research Institute at Baycrest
Study Sponsor  ICMJE Rotman Research Institute at Baycrest
Collaborators  ICMJE
  • Sunnybrook Health Sciences Centre
  • Toronto Rehabilitation Institute
  • The Centre for Memory and Aging
  • University of Waterloo
Investigators  ICMJE
Principal Investigator: Carol E Greenwood, PhD Rotman Research Institute Baycrest Health Sciences
Principal Investigator: Nicole D Anderson, PhD Rotman Research Institute Baycrest Health Sciences
PRS Account Rotman Research Institute at Baycrest
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP