Alzheimer's Disease, Late OnsetFIT-ADNCT01954550
Effects of Aerobic Exercise for Treating Alzheimer's Disease
A study testing Cycling exercise and Range of motion/stretching exercise in people with Alzheimer's Disease, Late Onset, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Alzheimer's Disease, Late Onset
- What is being tested?
- Cycling exercise and Range of motion/stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 30 Apr 2021
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of probable or possible Alzheimer's disease (AD);
- 15≤ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects
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.
Read the detailed description
Aerobic exercise holds great promise for treating cognitive impairment, the hallmark symptom of Alzheimer's disease (AD), because it may attenuate brain atrophy. AD currently affects more than 5 million Americans, costing $203 billion in 2013 and causing poor outcomes such as loss of independence, low quality of life, and nursing home placement. Available drugs have only modest short-term effects on reducing or slowing cognitive impairment in AD. Hence, there is a pressing need to develop and test aerobic exercise interventions for AD. 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. Transportation will be provided to participants for all study-related activities including exercises. Participants who could not undergo MRI can still participate.
- Conditions
- Alzheimer's Disease, Late Onset
- Being tested
- Cycling exercise, Range of motion/stretching exercise
- Keywords
- Exercise, Dementia, Cognition, Brain Volume, Aging
- Medical subject headings
- Alzheimer Disease, Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling exerciseBehavioural
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.
Range of motion/stretching exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Range of motion/stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes (1)
Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI)
Only participants who qualified to undergo MRI will be assessed for hippocampal volume.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startMar 2014
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease, Late OnsetStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of St Thomas, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Fang Yu, PhD, Principal investigator, Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954550
- Sponsor's protocol ID
- 1306M356
- Other IDs
- 1R01AG043392-01A1
- Acronym
- FIT-AD
- Status last verified
- Feb 2022
- First submitted
- 20 Sep 2013
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 25304364Yu 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.
PubMed 36461134Yu 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.
PubMed 34690736Greimel 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.
PubMed 33780529Li 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.
PubMed 28039287
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects
- ClinicalTrials.gov ID
- NCT01954550
- Acronym / sponsor ID
- FIT-AD / 1306M356
- Conditions
- Alzheimer's Disease, Late Onset
- Keywords
- Exercise, Dementia, Cognition, Brain Volume, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of St Thomas, National Institute on Aging (NIA)
- Study start
- Mar 2014 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aerobic exercise holds great promise for treating cognitive impairment, the hallmark symptom of Alzheimer's disease (AD), because it may attenuate brain atrophy. AD currently affects more than 5 million Americans, costing $203 billion in 2013 and causing poor outcomes such as loss of independence, low quality of life, and nursing home placement. Available drugs have only modest short-term effects on reducing or slowing cognitive impairment in AD. Hence, there is a pressing need to develop and test aerobic exercise interventions for AD. 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. Transportation will be provided to participants for all study-related activities including exercises. Participants who could not undergo MRI can still participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling exercise | Experimental | Behavioral: Cycling exerciseAn 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. |
| Range of motion/stretching exercise | Sham comparator | Behavioral: Range of motion/stretching exerciseAn 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. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Diagnosis of probable or possible Alzheimer's disease (AD);
- 15≤ 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling exerciseAn 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. | Behavioural | Cycling exercise |
| Range of motion/stretching exerciseAn 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. | Behavioural | Range of motion/stretching exercise |
Primary outcome
Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
This outcome measure will be given to all study participants.
1 secondary outcome
Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI)
Time frame: Baseline, 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 25304364Yu 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.
- Derived from this study: PubMed 36461134Yu 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.
- Derived from this study: PubMed 34690736Yu 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.
- Derived from this study: PubMed 33780529Greimel 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.
- Derived from this study: PubMed 28039287Li 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.
- Study Listing at the Alzheimer's AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Yu, PhD principal investigator
Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling exercise and Range of motion/stretching exercise in people with Alzheimer's Disease, Late Onset, run by University of Minnesota at 1 site in United States.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (time frame: Baseline, 3 months, 6 months, 9 months, and 12 months). 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 NCT01954550, which also lists 5 linked publications.
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 11 Feb 2022.