Impacts of Different Training Modes (Intense Versus Ordinary) on the Immune System and Memory Functions in pwMS

NCT02571335 | Completed

• 1 other identifier: JBansi
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS) progressively develop impaired functional capacity and show reduced physical activity and cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS are therefore to increase levels of activity and participation leading to increase independence of the participants. In general exercise ranges from passive physiotherapy-based interventions to submaximal endurance training sessions. Current recommendations advise pwMS that exercise should be matched with the individual performance capacities. Exercise training in pwMS then has the potential to target and improve many components outlined in the ICF-model. Cytokines and neurotrophic factors have received increased attention in MS research and addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal regeneration linking the effects of exercise with MS pathogenesis. Data show positive connections between elevated neurotrophin concentrations, induction of neuroplasticity, recovery of the motor and cognitive functions and the applied training intensities. Similarly, intensive and progressive exercise bouts seem to have greater benefits on cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with dementia. Therefore, specific exercise prescriptions may be necessary for targeting the specific impairments also in pwMS. This study aims to evaluate two different training modalities (intensive versus normal) in pwMS. It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS. Based on the findings that higher training intensities facilitate greater benefits, it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations. The results will to help to clearer understand the benefits of each type of exercise conveyed for pwMS and will assist in the development of patient-specific exercise prescriptions.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Neurotrophic Factor BDNF

  Short- and long-term changes (pg/ml) of serum levels of the neurotrophic factor BDNF (t1--\>t2)

  3-weeks

Secondary Outcomes (6)

• Maximum Oxygen consumption (VO2peak)

  3-weeks

• Maximum heart rate (HRmax)

  3-weeks

• Maximum workload (Loadmax)

  3-weeks

• Fatigue

  3-weeks

• Health-related Quality of life

  3-weeks

Study Arms (2)

Intensive Training

EXPERIMENTAL

Treatment consists of endurance training in both groups of physiologically defined heart rate controlled cycling at 50-60 rounds per minutes (rpm) and progressive resistance training. Training groups differ in the applied intensities and frequencies.The IT will train less frequent but training sessions will be more intensive in its effects. Training will be performed daily in six sessions (three morning and three afternoon sessions), synchronized and individually matched to a ratio of active versus passive sessions of 2:1.

Behavioral: Intensive Training

Normal Training

ACTIVE COMPARATOR

The NT is the normal training performed out of the daily routine and outlines the usual care of the Valens clinic. Training will be performed in up to eight training sessions that will not be synchronized and not individually matched to a ratio of active versus passive sessions.

Behavioral: Normal Training

Interventions

Intensive Training BEHAVIORAL

Week 1: Ratio of continuous and interval training of 2:1. Entry point at day one with 20 min of continuous, physiologically defined heart rate controlled cycling at 50-60 rounds per minutes at 75% of HRpeak. Resistance training is performed with 70% of the subjective-felt 1-round maximum with three sets and 10-12 repetitions and three exercises for the upper and lower extremities. Week 2 Progression of endurance training: 4x5 minutes with 2 Minutes between each interval performed at 80% of HRmax Progression resistance training: 75% of the subjective-felt 1-round maximum with three sets and 8-10 repetitions and three exercises for the upper and lower extremities. Week 3 Same as week 2.

Also known as: Endurance and Resistance Training

Intensive Training

Normal Training BEHAVIORAL

The control intervention is the normal rehabilitation program of the Valens clinic.

Also known as: Endurance and Resistance Training

Normal Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EDSS 1.0 - 6.0
• Age 19 - 75 years

You may not qualify if:

• Persistent infections
• Severe cardiovascular and pulmonal diseases (renal failure, hepatic dysfunction, cardiovascular disease)
• Severe cardiovascular exacerbations (RR \> 240/120, HR above the age predicted maximum of 220-Age) during training
• Immunosuppressive therapy the day of CPET
• Life style factors and / or persistent addictions (drug or alcohol abuse)
• Inability to follow the study procedures (due to psychological disorders or dementia)
• Insufficient knowledge of the project language (German)
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Enrolment of the investigator, his / her family members, employees and other dependent persons,
• Specific concomitant therapy washout requirements prior to and/or during study participation,
• Dietary restrictions

Sponsors & Collaborators

• Klinik Valens: lead
• German Sport University, Cologne: collaborator

Study Sites (1)

Kliniken-Valens

Valens, Canton of St. Gallen, 7317, Switzerland

Location

Related Publications (1)

• Zimmer P, Bloch W, Schenk A, Oberste M, Riedel S, Kool J, Langdon D, Dalgas U, Kesselring J, Bansi J. High-intensity interval exercise improves cognitive performance and reduces matrix metalloproteinases-2 serum levels in persons with multiple sclerosis: A randomized controlled trial. Mult Scler. 2018 Oct;24(12):1635-1644. doi: 10.1177/1352458517728342. Epub 2017 Aug 21.

  PMID: 28825348 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juerg Kesselring, Prof

  Klinik Valens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Exercise Sciences, PhD

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 8, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)