Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Aerobic exercise, Virtual Reality, Leg cycling, Mobility disability
Brief summary
The goal of this novel study is to compare the effect of a combined cognitive rehabilitation and exercise approach on new learning and memory (NLM) in persons with multiple sclerosis (pwMS) and mobility disability.
Detailed description
The proposed research study will be the first to apply the Kessler Foundation modified Story Memory Technique (KF-mSMT®), the practice standard for cognitive rehabilitation, with one of two exercise programs. Alone, KF-mSMT® has been beneficial to NLM impairment, however, its effects are highly selective to list learning and as such, will not maximally restore NLM function. The combination of KF-mSMT® and exercise provides a robust approach towards maximal functional recovery.
Interventions
BEHAVIORALThe Kessler Foundation modified Story Memory Technique® (KF-mSMT®)
KF-mSMT is a memory retraining technique that consists of two-related skills: (1) imagery and (2) context/organization. The proposed KF-mSMT intervention includes 10 total sessions with 2 sessions per week for 5 weeks. Each session will last 45-60 minutes.
BEHAVIORALAerobic Exercise Training (AET) plus Virtual Reality (IDEAL)
The AET condition includes 12 weeks of supervised, progressive, moderate intensity cycle ergometry. The AET will include semi-immersive, interactive VR such the cycling speed on the bike will translate directly to perceived speed through the virtual environment.
BEHAVIORALStretching and Toning (S/T)
The S/T condition will include 12 weeks of supervised S/T activities that target the head/neck. shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.
Sponsors
Kessler Foundation
National Multiple Sclerosis Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be blinded to the intent of the two exercise conditions. The outcomes assessor will also be blinded to the random assignment of enrolled participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Be within the ages of 18 and 70 years of age * Speak English as their primary language * Confirmed MS diagnosis by a neurologist * Be relapse and steroid-free for at least 30 days * Mild-to-moderate self-reported mobility disability, based on the Patient Determined Disease Steps scale (PDDS) * Currently physically inactive, based on the Godin Leisure Time Exercise Questionnaire (GLTEQ) * Right handedness
Exclusion criteria
* History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression) * Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q) * Currently use medications that may impact cognition (ex: steroids, benzodiazepines) * Currently pregnant * Contraindication for MRI (metal or electronic devices in the body that are not considered MRI safe) * Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in objective new learning and memory (NLM). | Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) | The California Verbal Learning Test-Second Edition (CVLT-II) measures verbal learning and memory by having participants recall a list of words from 4 semantic categories. The word list is presented over 5 trials with a 20 minute delayed recall and recognition trial. Standardized T-scores range from 0-100, where higher scores indicated better performance. |
| Change in everyday memory | Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) | The Ecological Memory Simulations (EMS) is a multi-component test that measures memory as it relates to everyday life. Scores range from 0-205, where higher scores indicated better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hippocampal volume | Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) | MRI data will be collected in the Rocco Ortenzio Neuroimaging Center at Kessler Foundation using an FDA-approved 3.0 T Siemens Skyra scanner and a 32-channel head coil to measure the volume of bilateral hippocampi. |
| Change in hippocampal function | Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) | fMRI data will be collected during a list-learning task conducted while in the FDA-approved 3.0 T Siemens Skyra scanner with a 32-channel head coil. |
Countries
United States
Contacts
CONTACTCarly Wender, PhD
PRINCIPAL_INVESTIGATORCarly Wender, PhD
Kessler Foundation
Outcome results
None listed