Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients

NCT ID: NCT02771652

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-11-30

Brief Summary

In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

e-training intervention

Resistance and endurance training

Group Type: ACTIVE_COMPARATOR

e-training

Intervention Type: BEHAVIORAL

The e-training intervention is a home-based aerobic and resistance training program. Resistance training was prescribed twice weekly for a period of 12 weeks. No special equipment was necessary except an elastic exercise band or a large gymnastic ball. In addition, endurance training was to be carried out once a week. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels. Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard). The exercise training was home-based and supervised via the internet. Participants continued exercise training for another 12 weeks after the 3month assessment.

Control

no exercise

Group Type: OTHER

Control

Intervention Type: OTHER

After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour. After waiting three months, they received the same e-training intervention as the intervention group had received from the start.

Interventions

e-training

The e-training intervention is a home-based aerobic and resistance training program. Resistance training was prescribed twice weekly for a period of 12 weeks. No special equipment was necessary except an elastic exercise band or a large gymnastic ball. In addition, endurance training was to be carried out once a week. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels. Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard). The exercise training was home-based and supervised via the internet. Participants continued exercise training for another 12 weeks after the 3month assessment.

Intervention Type: BEHAVIORAL

Control

After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour. After waiting three months, they received the same e-training intervention as the intervention group had received from the start.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosed Multiple Sclerosis (McDonald criteria),
• an EDSS score of less than or equal to 4.0,
• not less than 4 weeks of clinical stability prior to inclusion in the study,
• access to the internet.
• the taking of immunotherapeutic agents was not relevant and not monitored

Exclusion Criteria

• primary progressive multiple sclerosis
• clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Caritas-Krankenhaus Bad Mergentheim

OTHER

Sponsor Role: collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Klaus Pfeifer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Mäurer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Caritas-Krankenhaus Bad Mergentheim

References

Tallner A, Tzschoppe R,Peters S, Mäurer M, Pfeifer K. Internetgestützte Bewegungsförderung bei Personen mit Multipler Sklerose. Neurologie und Rehabilitation 19(1): 35-46, 2013.

Reference Type: BACKGROUND

Study Documents

Document Type: Detailed intervention description

Detailed description of the processes of the e-training intervention (english language)

View Document

Document Type: Clinical Study Report

Final report for funding foundation (german)

View Document

Other Identifiers

1.01.1/09/007

Identifier Type: -

Identifier Source: org_study_id