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Subjective Cognitive DeclineLEADNCT03056508

Lifestyle, Exercise and Diet: The LEAD Study

A study testing Exercise plus nutrition and Exercise in people with Subjective Cognitive Decline and Age-Related Cognitive Decline, run by Rotman Research Institute at Baycrest at 4 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
What is being tested?
Exercise plus nutrition and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
4 sitesCanada
Study dates
1 Jul 2018to 8 Oct 2020
Phase
Interventional
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • meeting criteria for subjective cognitive impairment (1 through 5 below)
  • Answer Yes to both following questions:
  • Do you feel like your memory or thinking is becoming worse?
  • Does this concern you?
  • 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;
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  • ≥5 for 8-15 years of education;
  • ≥3 for 0-7 years of education.
  • Have a Montreal Cognitive Assessment (MoCA) total score of 20 and over (≥20/30).
  • Have a delayed recall score on the CERAD word list of 5 and over (≥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

Who cannot join

  • 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.
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  • 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 locations and contacts

4 sites in 1 country.

Canada4 sites

  • Toronto Rehabilitation Institute Rumsey Centre

    Toronto, Ontario, M4G 2V6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Rotman Research Institute

    Toronto, Ontario, M6A 2E1

  • Centre for Community, Clinical Applied Research Excellence (CCCARE) at the University of Waterloo

    Waterloo, Ontario

Other trials in Canada

About this study

Official title: Nutrition, Exercise and Lifestyle: Team 6 of the Canadian Consortium on Neurodegeneration in Aging (CCNA)

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.

Read the 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.

Being tested
Exercise plus nutrition, Exercise
Keywords
diet, nutrition, aerobic exercise, cognition, grey matter, cerebral blood flow, neural activity, resting state connectivity

What participants receive

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

  • Exercise plus nutritionBehavioural

    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.

  • ExerciseBehavioural

    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 groups in NCT03056508
Study groupRoleWhat they receive
Exercise plus NutritionExperimental6 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).
Receives: Behavioral: Exercise plus nutrition
ExerciseActive comparatorIdentical exercise to the experimental plus education and passive discussion about brain health and healthy lifestyle to control for experimental group nutrition sessions.
Receives: Behavioral: Exercise

What is being measured

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

  1. Changes from baseline brain structure at 6 months and 12 months.

    Cortical and subcortical grey matter density using MRI three-dimensional T1 weighted structural scan (MPRAGE)

    Measured: 6 months plus 6 month follow-up

Secondary outcomes (20)

  1. Changes from baseline cerebral blood flow at 6 months and 12 months.

    Pseudo-continuous arterial spin labeling MRI (pcASL) to quantify cerebral blood flow

    Measured: 6 months plus 6 month follow-up

  2. Changes from baseline cognition at 6 months and 12 months

    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.

    Measured: 6 months plus 6 month follow-up

  3. Changes from baseline brain activity related to attention at 6 months and 12 months

    BOLD functional MRI while participants performing an attention task

    Measured: 6 months plus 6 month follow-up

  4. Changes from baseline resting state connectivity at 6 months and 12 months

    BOLD functional MRI while participants at rest

    Measured: 6 months plus 6 month follow-up

  5. Changes from baseline diet quality at 6 months and 12 months

    Principle component analyses based on Canadian Diet History Questionnaire II (C-DHQII)

    Measured: 6 months plus 6 month follow-up

  6. Changes from baseline adherence to diet recommendations at 6 months and 12 months

    Principle component analyses based on the Eating Pattern Self-Assessment

    Measured: 6 months plus 6 month follow-up

  7. Changes from baseline grip strength at 6 months and 12 months

    Grip strength using a hand held dynamometer

    Measured: 6 months plus 6 month follow-up

  8. Changes from baseline gait performance at 6 months and 12 months

    Gait velocity, stride length/width, and associated variability assessed using a GAITRite pressure sensor mat.

    Measured: 6 months plus 6 month follow-up

  9. Changes from baseline balance performance at 6 months and 12 months

    Posturography assessment on balance platform

    Measured: 6 months plus 6 month follow-up

  10. Changes from baseline maximal oxygen uptake at 6 months and 12 months

    VO2max determined during cardiopulmonary assessment

    Measured: 6 months plus 6 month follow-up

  11. Changes from baseline blood moderators at 6 months and 12 months

    e.g. BDNF, pro-BDNF, ApoE,

    Measured: 6 months plus 6 month follow-up

  12. Changes from baseline HbA1C at 6 months and 12 months

    HbA1C

    Measured: 6 months plus 6 month follow-up

  13. Changes from baseline fasting glucose at 6 months and 12 months

    fasting glucose

    Measured: 6 months plus 6 month follow-up

  14. Changes from baseline insulin levels at 6 months and 12 months

    insulin

    Measured: 6 months plus 6 month follow-up

  15. Changes from baseline lipid levels at 6 months and 12 months

    lipid profile

    Measured: 6 months plus 6 month follow-up

  16. Changes from baseline homocysteine levels at 6 months and 12 months

    homocysteine

    Measured: 6 months plus 6 month follow-up

  17. Changes from baseline C reactive protein levels at 6 months and 12 months

    CRP

    Measured: 6 months plus 6 month follow-up

  18. Changes from baseline TNF-alpha levels at 6 months and 12 months

    TNF-alpha

    Measured: 6 months plus 6 month follow-up

  19. Changes from baseline IL6 levels at 6 months and 12 months

    IL6

    Measured: 6 months plus 6 month follow-up

  20. Changes from baseline vitamin K levels at 6 months and 12 months

    Vitamin K

    Measured: 6 months plus 6 month follow-up

Timeline

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

  1. First posted17 Feb 2017
  2. Study start1 Jul 2018
  3. Primary completion8 Oct 2020
  4. Study completion8 Oct 2020

Why it stopped: 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.

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03056508
Sponsor's protocol ID
CCNA-NELT
Acronym
LEAD
Status last verified
Oct 2020
First submitted
9 Feb 2017
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: data will be uploaded to shared CCNA database - LORIS

Publications

  • Koblinsky ND, Anderson ND, Ajwani F, Parrott MD, Dawson D, Marzolini S, Oh P, MacIntosh B, Middleton L, Ferland G, Greenwood CE. Feasibility and preliminary efficacy of the LEAD trial: a cluster randomized controlled lifestyle intervention to improve hippocampal volume in older adults at-risk for dementia. Pilot Feasibility Stud. 2022 Feb 9;8(1):37. doi: 10.1186/s40814-022-00977-6.

    PubMed 35139918

Questions about this trial

What is this clinical trial studying?

A study testing Exercise plus nutrition and Exercise in people with Subjective Cognitive Decline and Age-Related Cognitive Decline, run by Rotman Research Institute at Baycrest at 4 sites in Canada.

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 16 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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 was stopped early (reason given: 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.). Results are not available in the source record.

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?

Changes from baseline brain structure at 6 months and 12 months. (time frame: 6 months plus 6 month follow-up). 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 NCT03056508, which also lists 1 linked publication.

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 14 Oct 2020.

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