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Effects of Ten-Weeks Power Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Resistance training
Testing sessions
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Resistance training group

Arm Description

Only testing sessions

Ten weeks of resistance training

Outcomes

Primary Outcome Measures

Maximal Voluntary Isometric Contraction of Knee Extension
Maximal Voluntary Isometric Contraction of Knee Extension
Rate of Force Development
Rate of Force Development
Central Activation Ratio
Central Activation Ratio
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
Karolinska Sleep Diary and Acelerometry
Sleep Quality
Karolinska Sleep Diary and Acelerometry

Full Information

First Posted
February 17, 2020
Last Updated
October 22, 2020
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04276324
Brief Title
Effects of Ten-Weeks Power Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility in Persons With Multiple Sclerosis
Official Title
Effects of Ten-Weeks Resistance Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility in Persons With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
October 15, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

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
Resistance training group
Arm Type
Experimental
Arm Description
Ten weeks of resistance training
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
Ten weeks of resistance training
Intervention Type
Other
Intervention Name(s)
Testing sessions
Intervention Description
Testing sessions
Primary Outcome Measure Information:
Title
Maximal Voluntary Isometric Contraction of Knee Extension
Time Frame
Before the program training
Title
Maximal Voluntary Isometric Contraction of Knee Extension
Time Frame
After 10 weeks
Title
Rate of Force Development
Time Frame
Before the program training
Title
Rate of Force Development
Time Frame
After 10 weeks
Title
Central Activation Ratio
Time Frame
Before the program training
Title
Central Activation Ratio
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
Karolinska Sleep Diary and Acelerometry
Time Frame
Before the program training
Title
Sleep Quality
Description
Karolinska Sleep Diary and Acelerometry
Time Frame
After 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 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 Católica San Antonio de Murcia
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 the study

Learn more about this trial

Effects of Ten-Weeks Power Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility in Persons With Multiple Sclerosis

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