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

Multiple Sclerosis Clinical Trial

— ms-intakt  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771652
• Other study ID #: 1.01.1/09/007
• Status: Completed
• Phase: N/A
• First received: May 4, 2016
• Last updated: June 23, 2016
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: June 2016
• Source: University of Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	Caritas-Krankenhaus Bad Mergentheim

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   certified as patient education program (german)
•   Link to the internet training platform, individual logins for every participant
•   Official project platform for participants (german)