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Power Training in Older Multiple Sclerosis Patients (POTOMS)

Primary Purpose

Multiple Sclerosis, Sclerosis, Demyelinating Autoimmune Diseases, CNS

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Power training
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Healthy aging, Exercise, Neuroprotection

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Signed consent
  • Clinical MS diagnosis according to the McDonald criteria (only applicable for PwMS)
  • EDSS ≤6.5 (only applicable for PwMS)
  • Able to transport themselves to the testing sessions in Aarhus
  • Able to transport themselves to training, if randomized to the training group

Exclusion Criteria:

  • Comprise comorbidities (cardiovascular-, respiratory-, orthopedic- or other neurological diseases
  • Pacemaker
  • Metallic implant that prevents MRI scans
  • Participation in structured RT or power training for the past 3 months (> 1 session per week)
  • Cognitive impairments (The participant is not able to understand and follow training- and testing instructions)

Sites / Locations

  • Tobias GæmelkeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training Group Multiple Sclerosis

Control Group Multiple Sclerosis

Arm Description

24 weeks of moderate to high-intensity power training (resistance training- emphasizing an explosive concentric phase of muscle contraction) performed twice weekly. Balance- and functional exercises are included after week 8.

Habitual lifestyle including standard care.

Outcomes

Primary Outcome Measures

Percentage brain volume change.
Whole brain atrophy will be measured from MRI-scans.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2021
Last Updated
June 21, 2023
Sponsor
University of Aarhus
Collaborators
University of Southern Denmark, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04762342
Brief Title
Power Training in Older Multiple Sclerosis Patients
Acronym
POTOMS
Official Title
Power Training in Older Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
August 28, 2024 (Anticipated)
Study Completion Date
August 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
University of Southern Denmark, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study seeks to investigate whether 24 weeks of power training has neuroprotective effects in older PwMS. Additional purposes are to examine the effects of 24 weeks power training on physical function, cognitive function and neuromuscular function. Further, it is investigated whether the potential effects of power training are maintained after 24 weeks of follow-up.
Detailed Description
Over the past 3-4 decades, the lifespan among people with multiple sclerosis (MS) has increased substantially. Today more than one-third of all people with MS are 60 years or older. With advanced age, people with MS are more likely to have impairments in cognitive and physical function. Positive adaptations within the nervous system (~neuroplasticity) have been shown to occur in people with MS following periods of resistance training (RT). This resembles the observations in young and old healthy individuals. Moreover, a specific type of RT termed power training appears to be particularly beneficial, as it emphasizes an explosive concentric phase of muscle contraction. This taxes the nervous system to a very high extent. As a result, power training has been shown to improve several aspects that rely on the nervous system in older individuals without MS. These aspects include cognition, neuromuscular function, and physical function. The investigators speculate that older people with MS would also benefit. However, no studies have looked into the effects of power training in older people with MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Demyelinating Diseases, Healthy Aging, Aging
Keywords
Multiple Sclerosis, Healthy aging, Exercise, Neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training Group Multiple Sclerosis
Arm Type
Experimental
Arm Description
24 weeks of moderate to high-intensity power training (resistance training- emphasizing an explosive concentric phase of muscle contraction) performed twice weekly. Balance- and functional exercises are included after week 8.
Arm Title
Control Group Multiple Sclerosis
Arm Type
No Intervention
Arm Description
Habitual lifestyle including standard care.
Intervention Type
Other
Intervention Name(s)
Power training
Intervention Description
First a brief warm up on a stationary bike and uni-lateral knee raises is completed. Power training: Involves exercises performed with fast/explosive muscle contraction during the concentric phase, and slow/controlled (approximately 2-3 s) muscle contraction during the eccentric phase. Functional- and balance exercises are included from week 9-24. Progression: Week 1-4: 3 sets of 12 repetitions at a load of 14 repetitions maximum (RM) with focus on introducing resistance exercise and familiarizing participants with exercises. Week 5-8: 3 sets of 12 repetitions at a load of 14 RM the power training component. Week 9-16: 3 sets of 10 repetitions at a load of 12 RM. Week 17-24: 3 sets of 8 repetitions at a load of 10 RM Strengthening exercises: Bilateral leg-press Bilateral plantar flexion Bilateral knee extension Unilateral banded dorsal flexion Bilateral lying leg curl Back extension Shoulder press Seated row Chest press Lat pull-down
Primary Outcome Measure Information:
Title
Percentage brain volume change.
Description
Whole brain atrophy will be measured from MRI-scans.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Other Pre-specified Outcome Measures:
Title
Normalized gray and white matter volume change.
Description
MRI scan.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Volume of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex
Description
MRI scan.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Diffusivity of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex
Description
DTI scan.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
White matter fibre orientations
Description
MKI scan.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Glial fibrillary acidic protein (GFAP) change.
Description
Resting blood sample- Marker of neurodegeneration.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Neurofilament light chain (NfL) change.
Description
Resting blood sample-Marker of neurodegeneration:
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Brain-derived neurotrophic factor (BDNF) change.
Description
Resting blood sample-Neurotrophic factor.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Insulin-like growth factor-1 (IGF).
Description
Resting blood sample-Neurotrophic factor.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
C-reactive protein (CRP) change.
Description
Resting blood sample-Inflammatory markers.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Interleukin-6 (IL-6) change.
Description
Resting blood sample-Inflammatory markers.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Tumor necrosis alpha (TNF-alpha) change.
Description
Resting blood sample-Inflammatory markers.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
C-terminal collagen cross-links (CTX) change.
Description
Resting blood sample- Bone turnover markers.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Type-1n-terminal propeptide (P1NP) change.
Description
Resting blood sample- Bone turnover markers.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Bone mineral density of the femoral neck and lumbar spine change.
Description
Dexa scan.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Body composition change.
Description
Dexa scan- whole body scan.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Cognition change .
Description
Selective Reminding Test (memory) and Symbol Digit Modalities Test (processing speed).
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Nine step stair test change.
Description
Time to climb a 9 step flight of stairs.
Time Frame
Baseline, after 24 weeks and after 48 weeks
Title
Six Spot Step Test (SSST) change.
Description
SSST is a measure of walking ability, balance and coordination. Measured as the time to complete the course.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Six-minute walk test (&MWT) change.
Description
Distance covered on a 30 meter track during six minutes maximal walking. Distance covered each minute is noted.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Timed 25-Feet Walk Test (T25FWT) change.
Description
Time to walk 25 feet (normal walk and maximal walk pace).
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Short Physical performance battery change.
Description
Composite score from Five Times Sit- to- Stand Test, Tandem Test and 3 meter walk test.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Maximal Voluntary Contraction (MVC) change.
Description
The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Rate of force development (RFD) change.
Description
The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Dynamic Strength change.
Description
The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Force Steadiness change.
Description
Unilateral leg press
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Voluntary activation
Description
Interpolated twitch technique applied on the quadriceps muscle
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Electromyography (EMG)
Description
The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Grip strength change.
Description
Measured by Hand Dynamoter.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
SF-12 change.
Description
Patient Reported Outcome Measure.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Pittsburg Sleep Qulity Index change.
Description
Patient Reported Outcome Measure.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Brief pain inventory change.
Description
Patient Reported Outcome Measure.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Baecke Physical Activity change.
Description
Patient Reported Outcome Measure.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
HADS change.
Description
Patient Reported Outcome Measure.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
EQ-5D change.
Description
Patient Reported Outcome Measure.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
FES-I change.
Description
Patient Reported Outcome Measure.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Multiple Sclerosis Impact Scale (MSIS-29) change.
Description
Patient Reported Outcome Measure (only applicable for people with MS).
Time Frame
Baseline, after 24 weeks and after 48 weeks .
Title
Modified Fatigue Impact Scale (MFIS) change.
Description
Patient Reported Outcome Measure (only applicable for people with MS).
Time Frame
Baseline, after 24 weeks and after 48 weeks .
Title
12-Item MS walking Scale (MSWS-12) change.
Description
Patient Reported Outcome Measure (only applicable for people with MS).
Time Frame
Baseline, after 24 weeks and after 48 weeks .
Title
Expanded Disability Status Scale (only applicable for people with MS).
Description
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a trained exercise physiologist.
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Nine hole peg test
Description
Manual dexterity and upper body function
Time Frame
Baseline, after 24 weeks and after 48 weeks.
Title
Physical activity
Description
Accelerometry (7 days ware time)
Time Frame
Baseline, after 24 weeks and after 48 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥ 60 years of age. Clinically diagnosed with MS according to the McDonald criteria (48). Having an EDSS ≤ 6.5. able to transport themselves to the testing at Aarhus University and Aarhus University Hospital. able to transport themselves to training, if randomized to the PRP group. Exclusion Criteria: having comorbidities (cardiovascular, respiratory, orthopedic, or other neurological diseases than MS) affecting PRP participation or MRI scans. having a pacemaker. having metallic implant(s) that prevents MRI scans. having untreated osteoporosis; t-score below -2.5 and a history of low energy facture or t-score below -3.0. participating in more than two sessions per week of structured PRE and have done so for the past 3 months. Are cognitively impaired at a level expected to prevent the participant from understanding training and testing instructions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Gaemelke, MSc
Phone
+45 28264508
Email
gaemelke@ph.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Gaemelke, Msc
Organizational Affiliation
Exercise Biology, Department of Public Health, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tobias Gæmelke
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias K. Gaemelke, Msc
Phone
+45 28264508
Email
gaemelke@ph.au.dk

12. IPD Sharing Statement

Plan to Share IPD
No
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Power Training in Older Multiple Sclerosis Patients

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