NCT01954550

Brief Summary

This randomized controlled trial (RCT) will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention on cognition and hippocampal volume in AD with three aims:

  • Determine the immediate effect of the cycling intervention on cognition in AD.
  • Examine if the cycling intervention slows cognitive decline in AD from baseline to 12 months.
  • Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using MRI. The investigators will randomize 90 participants to the 6-month cycling or stretching/range of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6, and 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

7.2 years

First QC Date

September 20, 2013

Last Update Submit

February 9, 2022

Conditions

Alzheimer's Disease, Late Onset

Keywords

ExerciseDementiaCognitionBrain VolumeAging

Outcome Measures

Primary Outcomes (1)

  • Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale

    This outcome measure will be given to all study participants.

    Baseline, 3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (1)

  • Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI)

    Baseline, 6 months, and 12 months

Study Arms (2)

Cycling exercise

EXPERIMENTAL

An exercise interventionist will guide and supervise participants to participate in moderate-intensity cycling on recumbent stationary cycles for 20-50 minutes, 3 times a week for 6 months.

Behavioral: Cycling exercise

Range of motion/stretching exercise

SHAM COMPARATOR

An exercise interventionist will guide and supervise participants to participate in low-intensity range of motion/stretching exercise for 20-50 minutes, 3 times a week for 6 months.

Behavioral: Range of motion/stretching exercise

Interventions

Cycling exerciseBEHAVIORAL

An exercise interventionist will guide and supervise participants to participate in moderate-intensity cycling on recumbent stationary cycles for 20-50 minutes, 3 times a week for 6 months.

Cycling exercise
Range of motion/stretching exerciseBEHAVIORAL

An exercise interventionist will guide and supervise participants to participate in low-intensity range of motion/stretching exercise for 20-50 minutes, 3 times a week for 6 months.

Range of motion/stretching exercise

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosis of probable or possible Alzheimer's disease (AD);
  • ≤ Mini-Mental State Examination (MMSE) score ≤26;
  • Clinical Dementia Rating score 0.5-2;
  • Community-dwelling, e.g., homes and assisted living;
  • Age 66 years and older;
  • English-speaking;
  • Verified exercise safety by the primary care providers and the cardiologists if subjects have significant cardiac history;
  • Stable on AD drugs \>1 month if AD drugs are prescribed.

You may not qualify if:

  • Resting heart rate (HR) ≤50 or ≥100 beats/min;
  • Neurological disorders in the past 5 years;
  • Psychiatric disorders in the past 5 years;
  • Alcohol or chemical dependency in the past 5 years;
  • Contraindications to exercise;
  • New symptoms or diseases that have not been evaluated by a health care provider, e.g., hip fracture, ongoing and unplanned weight loss, severe shortness of breath, deep vein thrombosis, hernia, unhealed sores, joint swelling, pain or trouble walking;
  • Cardiac ischemia or serious arrhythmia on the electrocardiograph during the screening exercise test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (5)

  • Yu F, Bronas UG, Konety S, Nelson NW, Dysken M, Jack C Jr, Wyman JF, Vock D, Smith G. Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer's disease: study protocol of a randomized controlled trial (The FIT-AD trial). Trials. 2014 Oct 11;15:394. doi: 10.1186/1745-6215-15-394.

    PMID: 25304364BACKGROUND

  • Yu F, Han SY, Salisbury D, Pruzin JJ, Geda Y, Caselli RJ, Li D. Feasibility and preliminary effects of exercise interventions on plasma biomarkers of Alzheimer's disease in the FIT-AD trial: a randomized pilot study in older adults with Alzheimer's dementia. Pilot Feasibility Stud. 2022 Dec 2;8(1):243. doi: 10.1186/s40814-022-01200-2.

    PMID: 36461134DERIVED

  • Yu F, Mathiason MA, Han S, Gunter JL, Jones D, Botha H, Jack C Jr. Mechanistic Effects of Aerobic Exercise in Alzheimer's Disease: Imaging Findings From the Pilot FIT-AD Trial. Front Aging Neurosci. 2021 Oct 7;13:703691. doi: 10.3389/fnagi.2021.703691. eCollection 2021.

    PMID: 34690736DERIVED

  • Greimel S, Wyman JF, Zhang L, Yu F. Recruitment and Screening Methods in Alzheimer's Disease Research: The FIT-AD Trial. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):547-553. doi: 10.1093/gerona/glab092.

    PMID: 33780529DERIVED

  • Li D, Thomas R, Tsai MY, Li L, Vock DM, Greimel S, Yu F. Vascular biomarkers to predict response to exercise in Alzheimer's disease: the study protocol. BMJ Open. 2016 Dec 30;6(12):e011054. doi: 10.1136/bmjopen-2016-011054.

    PMID: 28039287DERIVED

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseMotor ActivityDementia

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fang Yu, PhD

    Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

October 1, 2013

Study Start

March 1, 2014

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

US(1)