Lifestyle, Exercise and Diet: The LEAD Study

Rotman Research Institute at Baycrest

Status: Terminated

Conditions: Age-Related Cognitive Decline; Subjective Cognitive Decline

Treatments: Behavioral: Exercise; Behavioral: Exercise plus nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03056508

CCNA-NELT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Exercise plus Nutrition

Experimental group

Description:

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).

Treatment:

Behavioral: Exercise plus nutrition

Exercise

Active Comparator group

Description:

Identical exercise to the experimental plus education and passive discussion about brain health and healthy lifestyle to control for experimental group nutrition sessions.

Treatment:

Behavioral: Exercise