Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical exercise
Testing sessions
Sponsored by

About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring neurological disorders, resistance training, strength training, sleep quality, neuromuscular performance, functional capacity
Eligibility Criteria
Inclusion Criteria:
- mild or moderate disability with clinical mild spastic-ataxic gait disorder.
- stable phase of the disease.
Exclusion Criteria:
- Expanded Disability Status Scale (EDSS) < 6.
- relapsing disease within the preceding 12 months.
- corticosteroid treatment within the last months before study inclusion.
Sites / Locations
- Universidad Católica San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Progressive resistance training group
Arm Description
Only testing sessions
10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.
Outcomes
Primary Outcome Measures
Maximal Voluntary Isometric Contraction of Knee Extension
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Maximal Voluntary Isometric Contraction of Knee Extension
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Rate of Force Development
Rate of force development in knee extension
Rate of Force Development
Rate of force development in knee extension
Central Activation Ratio
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Central Activation Ratio
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Spasticity
Pendulum test
Spasticity
Pendulum test
Secondary Outcome Measures
Walking speed
Test 10 m-walks
Walking speed
Test 10 m-walks
Static Balance
Romberg Test with eyes open and closed. Analysis with force plates
Static Balance
Romberg Test with eyes open and closed. Analysis with force plates
Functional capacity
Sit-to-Stand Test
Functional capacity
Sit-to-Stand Test
Heart Rate Variability
Sleeping Heart Rate Variability
Heart Rate Variability
Sleeping Heart Rate Variability
Sleep Quality
Acelerometry and Karolinska Sleep Diary
Sleep Quality
Acelerometry and Karolinska Sleep Diary
Full Information
NCT ID
NCT04452760
First Posted
June 24, 2020
Last Updated
October 7, 2020
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT04452760
Brief Title
Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Official Title
Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Strength training has been shown to improve strength and mobility in persons with MS.
Detailed Description
Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Resistance training has been shown to improve strength, sleep quality and mobility in persons with MS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
neurological disorders, resistance training, strength training, sleep quality, neuromuscular performance, functional capacity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Only testing sessions
Arm Title
Progressive resistance training group
Arm Type
Experimental
Arm Description
10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
Physical exercise intervention
Intervention Type
Other
Intervention Name(s)
Testing sessions
Intervention Description
Testing sessions
Primary Outcome Measure Information:
Title
Maximal Voluntary Isometric Contraction of Knee Extension
Description
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Time Frame
Before the program training
Title
Maximal Voluntary Isometric Contraction of Knee Extension
Description
the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
Time Frame
After 10 weeks
Title
Rate of Force Development
Description
Rate of force development in knee extension
Time Frame
Before the program training
Title
Rate of Force Development
Description
Rate of force development in knee extension
Time Frame
After 10 weeks
Title
Central Activation Ratio
Description
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Time Frame
Before the program training
Title
Central Activation Ratio
Description
The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
Time Frame
After 10 weeks
Title
Spasticity
Description
Pendulum test
Time Frame
Before the program training
Title
Spasticity
Description
Pendulum test
Time Frame
After 10 weeks
Secondary Outcome Measure Information:
Title
Walking speed
Description
Test 10 m-walks
Time Frame
Before the program training
Title
Walking speed
Description
Test 10 m-walks
Time Frame
After 10 weeks
Title
Static Balance
Description
Romberg Test with eyes open and closed. Analysis with force plates
Time Frame
Before the program training
Title
Static Balance
Description
Romberg Test with eyes open and closed. Analysis with force plates
Time Frame
After 10 weeks
Title
Functional capacity
Description
Sit-to-Stand Test
Time Frame
Before the program training
Title
Functional capacity
Description
Sit-to-Stand Test
Time Frame
After 10 weeks
Title
Heart Rate Variability
Description
Sleeping Heart Rate Variability
Time Frame
Before the program training
Title
Heart Rate Variability
Description
Sleeping Heart Rate Variability
Time Frame
After 10 weeks
Title
Sleep Quality
Description
Acelerometry and Karolinska Sleep Diary
Time Frame
Before the program training
Title
Sleep Quality
Description
Acelerometry and Karolinska Sleep Diary
Time Frame
After 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild or moderate disability with clinical mild spastic-ataxic gait disorder.
stable phase of the disease.
Exclusion Criteria:
Expanded Disability Status Scale (EDSS) < 6.
relapsing disease within the preceding 12 months.
corticosteroid treatment within the last months before study inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobo Á Rubio-Arias, Dr
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Católica San Antonio
City
Murcia
ZIP/Postal Code
30107
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be published in a journal
IPD Sharing Time Frame
After the completion of study
IPD Sharing Access Criteria
The data will be published in a journal
Citations:
PubMed Identifier
35905806
Citation
Andreu-Caravaca L, Ramos-Campo DJ, Chung LH, Rubio-Arias JA. Can strength training modify voluntary activation, contractile properties and spasticity in Multiple Sclerosis?: A randomized controlled trial. Physiol Behav. 2022 Oct 15;255:113932. doi: 10.1016/j.physbeh.2022.113932. Epub 2022 Jul 27.
Results Reference
derived
PubMed Identifier
34107841
Citation
Andreu-Caravaca L, Ramos-Campo DJ, Abellan-Aynes O, Avila-Gandia V, Chung LH, Manonelles P, Rubio-Arias JA. 10-Weeks of resistance training improves sleep quality and cardiac autonomic control in persons with multiple sclerosis. Disabil Rehabil. 2022 Sep;44(18):5241-5249. doi: 10.1080/09638288.2021.1934738. Epub 2021 Jun 9.
Results Reference
derived
Learn more about this trial
Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
We'll reach out to this number within 24 hrs