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Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Controlled combined exercise group
Conventional rehabilitation
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Controlled combined exercise, Cardiovascular fitness, Fatigue, Depression

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 20 - 45 years Newly diagnosed patients with multiple sclerosis Relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) EDSS 0-6 Signed informed consent Exclusion Criteria: Progressive forms of MS (PRMS or SPMS), Malignant MS Non-cooperation, disagreement with the study Contraindication to spiroergometry

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Controlled combined program (aerobic-resistant)

Conventional rehabilitation

No intervention

Arm Description

Patients randomized into the Experimental arm will undergo controlled exercise on a cycling ergometer in combination with strength training on a multifunctional fitness device for 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total).

Patients randomized into this study arm will undergo conventional rehabilitation.

Patients randomized into this study arm will undergo no intervention and will serve as the control group.

Outcomes

Primary Outcome Measures

Maximal aerobic capacity (VO2max.kg-1)
Change after six months follow up in conventional, experimental and control group
Power to weight ratio (W.kg-1)
Change after six months follow up in conventional, experimental and control group

Secondary Outcome Measures

Modified Fatigue Impact Scale (MFIS)
Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue
Symptom-Checklist-90-Standard (SCL-90-S)
Change in result of percentile score
Beck Depression Inventory Score II (BDI II)
Self-reported rating inventory that measures characteristic attitudes and symptoms of depression, 0-13 - minimal or none depression, 29-63 - severe depression
36-Item Short Form Survey (SF-36)
Self-reported measure of health-related quality of life, minimum 0 points, maximum 100 points - the higher score is the sign of better quality of life
Maximal heart rate (bpm)
Change after six months follow up in conventional, experimental and control group
Heart rate variability (ms)
Change after six months follow up in conventional, experimental and control group
Body composition analysis %)
Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent.

Full Information

First Posted
December 12, 2022
Last Updated
January 3, 2023
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT05671588
Brief Title
Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression
Official Title
Cardiovascular Fitness and the Influence of a Controlled Combined Exercise Program on Fatigue and Depression of Newly Diagnosed Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

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
This study is focused on patients with multiple sclerosis (MS), their cardiovascular fitness, and the effect of combined controlled training on the perception of fatigue, the development of depression, and quality of life in the first year after diagnosis.
Detailed Description
The main goal is to find out if fatigue, depression, and quality of life depend on the type of training as well as controlled management of newly diagnosed patients. Fatigue is one of the frequent disabling symptoms and the most difficult to influence pharmacologically. It could lead to inactivity and the progression of deconditioning. We know from systematic reviews that aerobic activity leads to improvement in fatigue, however, there are also opinions about exercise intolerance due to disruption of cardiac autonomy control. The investigators will try to determine whether early rehabilitation intervention leads to support and motivation of patients with an incurable chronic neurodegenerative disease to improve the patient condition and contentment. The researchers will focus on effective training by comparing the study group with a control group of patients undergoing conventional rehabilitation versus a protocol-defined controlled combined (aerobic-resistant) exercise program - based on the results of spiroergometry. Both groups will be treated at ambulatory sections by protocol-defined rehabilitation for a 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total). The control group will be educated in exercises according to kinesiological analysis to do regularly at home. Finally, the researchers will see if early intervention leads to a change in the active approach of probands.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Controlled combined exercise, Cardiovascular fitness, Fatigue, Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be enrolled into two parallel groups.
Masking
Outcomes Assessor
Masking Description
All participants of the study will undergo a clinical examination including a questionnaire survey and spiroergometry - examiners will not have access to intervention documents before and after the intervention (period of 6 months), as well as examiners will not perform the therapy.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Controlled combined program (aerobic-resistant)
Arm Type
Experimental
Arm Description
Patients randomized into the Experimental arm will undergo controlled exercise on a cycling ergometer in combination with strength training on a multifunctional fitness device for 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total).
Arm Title
Conventional rehabilitation
Arm Type
Active Comparator
Arm Description
Patients randomized into this study arm will undergo conventional rehabilitation.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Patients randomized into this study arm will undergo no intervention and will serve as the control group.
Intervention Type
Procedure
Intervention Name(s)
Controlled combined exercise group
Intervention Description
Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device
Intervention Type
Procedure
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Patients will undergo conventional rehabilitation.
Primary Outcome Measure Information:
Title
Maximal aerobic capacity (VO2max.kg-1)
Description
Change after six months follow up in conventional, experimental and control group
Time Frame
6 months
Title
Power to weight ratio (W.kg-1)
Description
Change after six months follow up in conventional, experimental and control group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Modified Fatigue Impact Scale (MFIS)
Description
Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue
Time Frame
6 months
Title
Symptom-Checklist-90-Standard (SCL-90-S)
Description
Change in result of percentile score
Time Frame
6 months
Title
Beck Depression Inventory Score II (BDI II)
Description
Self-reported rating inventory that measures characteristic attitudes and symptoms of depression, 0-13 - minimal or none depression, 29-63 - severe depression
Time Frame
6 months
Title
36-Item Short Form Survey (SF-36)
Description
Self-reported measure of health-related quality of life, minimum 0 points, maximum 100 points - the higher score is the sign of better quality of life
Time Frame
6 months
Title
Maximal heart rate (bpm)
Description
Change after six months follow up in conventional, experimental and control group
Time Frame
6 months
Title
Heart rate variability (ms)
Description
Change after six months follow up in conventional, experimental and control group
Time Frame
6 months
Title
Body composition analysis %)
Description
Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Cost-benefit analysis of early rehabilitation intervention (CZK)
Description
Cost-benefit analysis of early rehabilitation intervention will be performed and expressed as the price in Czech crowns (CZK).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20 - 45 years Newly diagnosed patients with multiple sclerosis Relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) EDSS 0-6 Signed informed consent Exclusion Criteria: Progressive forms of MS (PRMS or SPMS), Malignant MS Non-cooperation, disagreement with the study Contraindication to spiroergometry
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Šilarová, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Anna Šilarová, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Citations:
PubMed Identifier
32169035
Citation
Razazian N, Kazeminia M, Moayedi H, Daneshkhah A, Shohaimi S, Mohammadi M, Jalali R, Salari N. The impact of physical exercise on the fatigue symptoms in patients with multiple sclerosis: a systematic review and meta-analysis. BMC Neurol. 2020 Mar 13;20(1):93. doi: 10.1186/s12883-020-01654-y.
Results Reference
background
PubMed Identifier
33901439
Citation
Taul-Madsen L, Connolly L, Dennett R, Freeman J, Dalgas U, Hvid LG. Is Aerobic or Resistance Training the Most Effective Exercise Modality for Improving Lower Extremity Physical Function and Perceived Fatigue in People With Multiple Sclerosis? A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Oct;102(10):2032-2048. doi: 10.1016/j.apmr.2021.03.026. Epub 2021 Apr 24.
Results Reference
background
PubMed Identifier
25634170
Citation
Cruickshank TM, Reyes AR, Ziman MR. A systematic review and meta-analysis of strength training in individuals with multiple sclerosis or Parkinson disease. Medicine (Baltimore). 2015 Jan;94(4):e411. doi: 10.1097/MD.0000000000000411.
Results Reference
background
PubMed Identifier
24603938
Citation
Hansen D, Wens I, Keytsman C, Eijnde BO, Dendale P. Is long-term exercise intervention effective to improve cardiac autonomic control during exercise in subjects with multiple sclerosis? A randomized controlled trial. Eur J Phys Rehabil Med. 2015 Apr;51(2):223-31. Epub 2014 Mar 6.
Results Reference
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Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression

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