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 (ms-intakt)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: e-training; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: e-training intervention; Resistance and endurance training	Behavioral: 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.
Other: Control; no exercise	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)	38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood. The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL. The primary outcome will be the change over time from baseline to month 3.	Assessments took place at baseline and at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Würzburg Fatigue Scale (WEIMuS)	This questionnaire contains 17 items that form a physical and cognitive subscale. The total score ranges from zero to a maximum of 68 points (maximum fatigue). The cut-off value for the presence of fatigue is above 32.	Assessments took place at baseline, at 3 and 6 months
Muscle strength lower extremities	Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).	Assessments took place at baseline and after 3 and 6 months
Forced vital capacity	Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).	Assessments took place at baseline and after 3 and 6 months
Aerobic capacity	As a marker of endurance capacity, maximal oxygen uptake (VO2peak) was determined by the spiroergometry device Master Screen CPX on a bicycle ergometer (Sanabike 250F, MESA, Germany) at 70-80 revolutions per minute.	Assessments took place at baseline and after 3 and 6 months
Physical activity	Habitual physical activity was assessed with the German version of the Baecke Questionnaire including three activity indices (work, sport, leisure time PA). There were limitations concerning content validity in all indices; therefore, the sport score of the sport index was used. That score is the product of the intensity, duration and frequency of a participant's reported sports activities. Higher scores indicate a higher level of PA.	Assessments took place at baseline and after 3 and 6 months
Peak expiratory flow	Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).	Assessments took place at baseline and after 3 and 6 months

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg
• Collaborators: Caritas-Krankenhaus Bad Mergentheim
• Investigators: Principal Investigator: Matthias Mäurer, Dr., Caritas-Krankenhaus Bad Mergentheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• certified as patient education program (german)

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; exercise; Quality of Life; internet
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 1.01.1/09/007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Study Data/Documents

1. Detailed intervention description
   Information comments: Detailed description of the processes of the e-training intervention (english language)
2. Clinical Study Report
   Information comments: Final report for funding foundation (german)