Regular Exercise Improves Physical Capacity and Promotes Neurotrophins in Patients With Multiple Sclerosis

NCT04944251 | Completed

• 1 other identifier: 19-4T/43
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT Objective: The investigators aimed to determine the effect of regular exercise on aerobic capacity, strength values, and plasma levels of nerve growth factor (NGF) and Neurotrophin-3 (NT-3) in patients with multiple sclerosis (MS), and investigate its effects on MS symptoms including cognitive impairment, fatigue, balance disorders and quality of life. Methods: Forty-three relapsing-remitting MS (RRMS) patients with an EDSS score of 4 or less participated in the study. Participants were divided into 3 groups as aerobic exercise, strength exercise and control groups. The patients in the exercise groups had exercise programs 3 days a week, for 3 months. Aerobic capacity (maximum VO2 value), strength measurements and balance tests were done, and NGF and NT-3 plasma levels were analyzed in all participants at the beginning and end of the study. MSQoL54 quality of life, fatigue impact scale (FIS), Pittsburgh Sleep Quality Index (PSQI) and BICAMS scale were applied to evaluate cognitive functions.

Conditions

Multiple Sclerosis; Exercise Intervention; Neuro-Degenerative Disease

Keywords

multiple sclerosis; exercise; nerve growth factor; neurotrophin 3; cognition; quality of life

Outcome Measures

Primary Outcomes (3)

• Aerobic capacity assessment after exercise intervention

  Measurement of Aerobic Capacity: Milliliters were used for the amount of oxygen used, kilograms were used for body weight, and minutes were used for time. the amount of oxygen consumed, weight and time will be combined to report aerobic capacity in ml/kg/min. The unit of aerobic capacity, ml/kg/min, refers to the amount of oxygen the body consumes per kilogram per minute. The indirect Astrand test bicycle test protocol with Lode Corival bicycle ergometer was applied to all patients. The pedal resistance applied in the test and the mean pulse rate were marked in the Astrand normogram, and the aerobic capacities of the patients were calculated. It was observed that aerobic capacity (ml/kg/min) increased in exercise groups after regular exercise.

  Each participant's progress will be tested at the beginning and end of the 12-week training period.

• Strength assessment after exercise intervention

  Strength Measurements: The kilogram-force (kg-f) is a non-standard Gravitational Metric unit of force. The kilogram-force is equal to the magnitude of the force exerted on one kilogram of mass in a 9.80665 m/s2 gravitational field. Kilogram was used for weight. The force is any influence that, when unopposed, will change the motion of an object. Weight and force will be combined to report strength in kg-f. Strength was examined with an isometric hand and backleg dynamometer in all patients. Strength was examined with an isometric hand and backleg dynamometer in all patients. Two measurements were made, at the beginning and at the end of the study. It was observed that strength values increased in exercise groups after regular exercise.

  Each participant's progress will be tested at the beginning and end of the 12-week training period.

• plasma neurotrophin values (pg/ml)

  Plasma NGF and NT-3 levels were measured with an ELISA kit. Plasma neurotrophin values increased in exercise groups.

  Each participant's progress will be tested at the beginning and end of the 12-week training period.

Study Arms (3)

aerobic exercise group

EXPERIMENTAL

the patients in the aerobic group started to exercise at a heart rate corresponding to 60% of the maximal VO2, by adjusting the pedal resistance of the exercise bike, consistent with the Karvonen formula. This was followed by exercise cycling at a heart rate corresponding to 70% of maximal VO2 in the second month, and 80% of maximal VO2 in the third month, for 30 minutes, 3 days a week

Behavioral: Regular Exercise

strength exercise group

EXPERIMENTAL

The patients included in the strength exercise group performed weight training exercises involving 10 large muscle groups (leg press, chest press, leg curl, lateral pull down, leg extension, dumbbell lateral raise, calf press, upright row, sit up, quadruped arm opposite leg raise), 3 days a week; including 1 set of 12-15 repetitions in the first month, 2 sets of 12-15 repetitions in the second month, and 3 sets of 12-15 repetitions in the third month (Figure 1). Participants' working weights were set as 60% of the maximum weight they could lift.

Behavioral: Regular Exercise

control group

NO INTERVENTION

The patients who didn't want to exercise were included in the control group.

Interventions

Regular Exercise BEHAVIORAL

the third month, for 30 minutes or 1 hour, 3 days a week

aerobic exercise group; strength exercise group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A total of 53 relapsing remitting form MS (RRMS) patients between the ages of 18-55 years, diagnosed with definite MS according to 2017 McDonald criteria, and followed up in Ege University MS and Demyelinating Diseases Unit, without an MS attack in the last 3 months, had an EDSS score ≤ 4 that did not change with symptomatic or immunomodulatory treatments within 6 months were included in this prospective randomized controlled study.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (34)

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Related Links

• Results Reference

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Mehmet ACIK, Dr

  Ege University

  PRINCIPAL INVESTIGATOR

• Seckin Senisik, Ass. Prof.

  Ege University

  STUDY DIRECTOR

• Nur Yuceyar, Professor

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Model Details: randomized prospective study

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 29, 2021
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 19, 2020
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: anyone who wishes to access the data.

Locations

TU (1)