Combined Exercise Training in Patients With Multiple Sclerosis

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT03591809
Collaborator
(none)
17
1
2
13.6
1.3

Study Details

Study Description

Brief Summary

It is stated that the affected cognitive functions in Multiple Sclerosis are learning, memory, attention, speed of information processing, visuospatial skills, and executive functions. The speed of information processing, visual learning and memory are the most frequently affected components in MS. For this reason, approaches to increase cognitive functions by activating neuroprotective mechanisms such as exercise in patients with MS are needed.

The purpose of this study is to examine the effect of combined exercise training on cognitive functions in patients with MS.

Condition or Disease Intervention/Treatment Phase
  • Other: combined exercise training
N/A

Detailed Description

The study was designed as a randomized, controlled, single-blind trial. This study will include patients with MS who 0-5.5 according to the Extended Disability Status Scale (EDSS) and between 18-65 years. The patient will be randomized into a combined training group and a control group. The patients in the control group will not apply an exercise training. The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks. Both groups will be reevaluated 8 weeks after the initial assessment.

Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p< 0.05.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, controlled, single-blind trialRandomized, controlled, single-blind trial
Masking:
Single (Outcomes Assessor)
Masking Description:
To ensure blinding, the assessor physiotherapist will not be aware of the arm to which the subjects belong
Primary Purpose:
Treatment
Official Title:
The Effect of Combined Exercise Training on Cognitive Functions in Patients With Multiple Sclerosis
Actual Study Start Date :
Sep 3, 2018
Actual Primary Completion Date :
Oct 18, 2019
Actual Study Completion Date :
Oct 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: combined exercise training group

The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.

Other: combined exercise training
The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.

No Intervention: Control group

The patients in the control group will not apply an exercise training.

Outcome Measures

Primary Outcome Measures

  1. cognitive function [Thirty minutes]]

    The Brief Repeatable Battery of Neuropsychological Tests

Secondary Outcome Measures

  1. functional exercise capacity [ten minutes]

    The Six-Minute Walking Test (6MWT) was performed to determine functional exercise capacity

  2. Fatigue [five minutes]

    Fatigue impact scale will be used to asses fatigue. There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items). Cognitive functioning concerns concentration, memory, thinking and organization of thoughts. Physical functioning reflects motivation, effort, stamina and coordination. Psychosocial functioning describes the impact of fatigue upon isolation, emotions, workload and coping.A higher score indicates a higher fatigue impact.

  3. Multiple Sclerosis Quality of Life-54 [ten minutes]

    The questionnaire consists of 54 questions with 12 sub-sections; physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress, the overall quality of life, emotional well-being, role limitations-emotional, cognitive function. The summary scores are the physical health composite summary and the mental health composite summary. There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In this scale, the scoring of each question is different from each other and a higher score indicates a lower quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Ambulatory

  • Stable phase of the disease without relapses in the last 3 month

  • EDSS between 2-5,5.

Exclusion Criteria:
  • Orthopedic, vision, hearing, or perception problems

  • Any cardiovascular or pulmonary disease in which exercise is contraindicated

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gazi University Ankara Turkey

Sponsors and Collaborators

  • Gazi University

Investigators

  • Principal Investigator: Cagla Ozkul, Gazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cagla Ozkul, research assistant, Gazi University
ClinicalTrials.gov Identifier:
NCT03591809
Other Study ID Numbers:
  • 400
First Posted:
Jul 19, 2018
Last Update Posted:
Oct 22, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cagla Ozkul, research assistant, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2019