Reshaping the Path of Vascular Cognitive Impairment (VCI)

NCT ID: NCT02669394

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-17
• Study Completion Date: 2022-06-02

Brief Summary

The investigators will conduct a proof-of-concept randomized controlled trial study to provide preliminary evidence of efficacy of a resistance exercise training program for maintaining white matter health and improving cognitive function in older adults with vascular cognitive impairment, defined as the presence of cognitive impairment combined with cerebral small vessel disease, compared with a stretch and relaxation program.

Detailed Description

A total of 88 adults with vascular cognitive impairment will be randomized to either a 12-month twice-weekly resistance training program or stretch and relaxation program. There will be three measurement sessions: baseline, 6 months (midpoint of intervention period), and 12 months (end of intervention period).

Conditions

Transient Ischemic Attack; Vascular Cognitive Impairment; Subcortical Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Resistance Training (RT)

The RT program will be a twice-weekly program. A pressurized air system and free weights will be used . The pressurized air system exercises will consist of biceps curls, triceps extension, seated row, latissmus dorsi pull downs, leg press, hamstring curls, and calf raises. Other exercises, with free weights, will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method.

To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of a set of resistance bands of various weights. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and compliance.

Group Type: EXPERIMENTAL

Resistance exercise training

Intervention Type: BEHAVIORAL

Twelve months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

Stretching and Relaxation (CON)

The CON program will be a twice-weekly program. The CON group will consist of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.

To meet the public health mandates of COVID-19, when it is necessary, training will occur at home. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and compliance.

Group Type: ACTIVE_COMPARATOR

Control: stretching and relaxation program

Intervention Type: BEHAVIORAL

Twelve months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.

Interventions

Resistance exercise training

Twelve months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

Intervention Type: BEHAVIORAL

Control: stretching and relaxation program

Twelve months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.

Intervention Type: BEHAVIORAL

Other Intervention Names

RT Program; CON Program

Eligibility Criteria

Inclusion Criteria

The study will specifically recruit individuals who fulfill the diagnostic criteria for SIVCI -- the presence of both cognitive impairment and small vessel ischaemic disease.

1. Montreal Cognitive Assessment (MoCA) score less than 26 at screening;

2. MMSE score of = or > 20 at screening;

3. Community-dwelling;

4. Lives in Metro Vancouver;

5. Able to comply with scheduled visits, treatment plan, and other trial procedures;

6. Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;

7. Stable on a fixed dose of cognitive medications (e.g., donepezil, galantamine, rivastigmine, memantine, etc.) that is not expected to change during the 12-month study period, or, if they are not on any of these medications, they are not expected to start them during the 12-month study period;

8. Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals;

9. Able to walk independently; and

10. Must be in sufficient health to participate in study's aerobic-based exercise training program. This will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician indicating individual's appropriateness to participate in an aerobic-based exercise training program.

Exclusion Criteria

1. Absence of relevant small vessel ischaemic lesions on an existing brain computed tomography (CT) or MRI;

2. Diagnosed with another type of dementia (e.g., AD) or other neurological conditions (e.g., multiple sclerosis, Parkinson's disease, etc.) that affects cognition and mobility;

3. Diagnosed previously with a genetic cause of SIVCI (e.g., CADASIL);

4. At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);

5. Participating in regular RT in the last six months;

6. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;

7. Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.); or

8. Individual who plans to participate or is enrolled in a clinical drug trial concurrent to this study.

9. Unable to meet the specific scanning requirements of the UBC 3T MRI Research Centre. Specifically, we will exclude anyone with: pacemaker, brain aneurysm clip, cochlear implant, recent surgery or tattoos within the past 6 weeks, electrical stimulator for nerves or bones, implanted infusion pump, history of any eye injury involving metal fragments, artificial heart valve, orthopedic hardware, other metallic prostheses, coil, catheter or filter in any blood vessel, ear or eye implant, bullets, or other metallic fragments.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Teresa Liu-Ambrose

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Liu-Ambrose, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

John Best, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Jennifer Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Charlie Goldsmith, PhD

Role: PRINCIPAL_INVESTIGATOR

Simon Fraser University

Ging-Yuek Robin Hsiung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Roger Tam, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Thalia Field, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Kenneth Madden, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

References

Balbim GM, Boa Sorte Silva NC, Falck RS, Kramer AF, Voss MW, Liu-Ambrose T. 24-hour activity cycle behaviors and gray matter volume in mild cognitive impairment. Alzheimers Dement. 2025 Jul;21(7):e70496. doi: 10.1002/alz.70496.

Reference Type: DERIVED

PMID: 40693459 (View on PubMed)

Liu-Ambrose T, Dao E, Crockett RA, Barha CK, Falck RS, Best JR, Hsiung GR, Field TS, Madden KM, Alkeridy WA, Boa Sorte Silva NC, Davis JC, Ten Brinke LF, Doherty S, Tam RC. Reshaping the path of vascular cognitive impairment with resistance training: a study protocol for a randomized controlled trial. Trials. 2021 Mar 18;22(1):217. doi: 10.1186/s13063-021-05156-1.

Reference Type: DERIVED

PMID: 33736706 (View on PubMed)

Other Identifiers

H15-00972

Identifier Type: -

Identifier Source: org_study_id