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Implementation of eccentric training in various clinical populations - a pilot study

Organizational Data

DRKS-ID:
DRKS00020483
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-01-24
Last update in DRKS:
2020-01-24
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

Despite the high application potential in various clinical populations, eccentric training (here the focus is on exercises in which the muscles work in a lengthening mode against resistance) is only used very rarely in therapy. The aim of the study is to investigate the feasibility of a 6-week eccentric training program in two exemplary clinical populations in a multi-center study design.

Brief summary in scientific language

Eccentric training has a number of advantages over classic (concentric) training modalities (including increased strength gains and neuromuscular capacity, reduced metabolic and cardiovascular load while increasing strength). In spite of the high application potential in different clinical populations, eccentric training is used only very rarely in therapy. The aim of the study is to check the feasibility of an eccentric training program (6 weeks duration) in two exemplary clinical populations (back pain patients and people with multiple sclerosis) in a multi-center design. The focus is on the implementation of a mixed home and center-based training of the trunk-encompassing muscles and the muscles of the lower extremities. Potential intervention successes will be examined using a test battery consisting of standardized maximum force measurements, clinical function tests and specific health and pain questionnaires. In addition, blood samples will be repeatedly collected and evaluated over the period of the study in order to investigate possible systemic (anti) inflammatory reactions to the training.

Health condition or problem studied

ICD10:
M54 - Dorsalgia
ICD10:
G35 - Multiple sclerosis
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Control group (asymptomatic persons); eccentric training, duration 6 weeks; 3 sessions per week: 2x/week center-based, 1x/week home-based, 45 minutes per session
Arm 2:
Patients with back pain; eccentric training, duration 6 weeks; 3 sessions per week: 2x/week center-based, 1x/week home-based, 45 minutes per session
Arm 3:
Patients with multiples sclerosis; eccentric training, duration 6 weeks; 3 sessions per week: 2x/week center-based, 1x/week home-based, 45 minutes per session
Arm 4:
Patients with multiple sclerosis; Standard Care (Weekly physical therapy sessions focused on balance exercises)

Endpoints

Primary outcome:
Delta pre-post intervention for isokinetic peak force (dynamometer): - Low back pain: maximal trunk force (trunk flexion and extension) - Multiples sclerosis: maximal leg force (knee flexion and extension)
Secondary outcome:
Delta pre-post intervention for (1) Clinical Mobility tests: - „Timed Up and Go“ test; - „5-times Chair Rise“ test; (2) Postural control (COP measurements): - Double-leg stance; - Single-leg stance; (3) Questionnaires: - EQ-5D Health questionnaire; - Low back pain: Graded Chronic Pain Scale Questionnaire (van Korff); - Multiple Sclerosis: SF 36 quality of life in MS, Multiple Sclerosis Walking Scale (MSWS-12), Modified Fatigue Impact Scale (MFIS), Falls Efficacy Scale International (FES-I)

Study Design

Purpose:
Treatment
Allocation:
Non-randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor
  • Data analyst

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • Israel
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Sheba Medical Center Tel Aviv
  • Other Hochschulambulanz der Universität Potsdam Potsdam

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2019-07-30
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
54
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
65 Years
Additional Inclusion Criteria:
Control: - Males and females 18-65 years old; Low back pain group: - Minimum of 3 low back pain episodes within last 12 months (but not exclusively within the last 3 months, - Average Score of 3 or more for subjective pain within the last 3 months based on a 11-point pain rating scale (0: No pain; 10: maximal imaginable pain), - Males and females 18-65 years old; Multiples sclerosis: - A neurologist-confirmed diagnosis of definite MS according to the revised McDonald criteria Exclusion criteria, - <4.5 score on the Expanded Disability Status Scale (EDSS), the ability to walk an equivalent of at least 500m without a walking aid, - Relapse-free for at least 90 days prior to testing - Males and females 18-65 years old;

Exclusion Criteria

Control: - Acute infections, - Pregnancy, - Structural changes of the spine with or without neurological signs which contra-indicate physical activities, - Acute back pain, - Back pain (>24h) within the last 12 months, - Average Score of 3 or more for subjective pain within the last 3 months based on a 11-point pain rating scale (0: No pain; 10: maximal imaginable pain); Low back pain: - Acute infections, - Pregnancy, - Structural changes of the spine with or without neurological signs which contra-indicate physical activities, - Acute back pain, which occurred for the first time within the last 7 days; Multiple sclerosis: - Pregnancy, - Cardiovascular disorders, - Respiratory disorders, - Taking steroids or fampridine

Addresses

Primary Sponsor

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Dr. Anne Schraplau
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
00493319771753
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Dr. Anne Schraplau
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
00493319771753
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Dr. Anne Schraplau
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
00493319771753
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Tel-Aviv University, Department of Physical Therapy, The Stanley Steyer School of Health Professions, Sackler Faculty of Medicine and Sagol School of Neuroscience
P.O.B 3904, Ramat Aviv
69978 Tel Aviv
Israel
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Institutional Review Board of the Sheba Medical Center Tel-Hashomer [Ethikkommission der Universität Potsdam AND Institutional Review Board of the Sheba Medical Center, Tel-Hashomer (Israel) (Nr. SMC-6288-19)]
52621 Ramat Gan
Israel
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-05-22
Ethics committee number:
44/2019
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-06-21

Other Address Ethics Committee

Ethikkommission der Universität Potsdam
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uni-potsdam.de/senat/kommissionen-des-senats/ek.html

Vote of the Ethics Committee

Vote of the Ethics Committee:
No Entry
Date of the vote:
No Entry

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1246-3770
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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