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A randomized controlled pilot and feasibility study of multimodal agility-based exercise training versus strength and endurance training to improve Multiple Sclerosis-related fatigue and fatigability during inpatient rehabilitation

A randomized controlled pilot and feasibility study of multimodal agility-based exercise training versus strength and endurance training to improve Multiple Sclerosis-related fatigue and fatigability during inpatient rehabilitation - ReFEx

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023943
Enrollment
24
Registered
2021-09-23
Start date
2021-11-18
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: The intervention program (MAT) consists of two group therapies (i.e., water-based and land-based). Group therapies are scheduled as follows: land 5x/week, water 3x/week, 30min training time p

Sponsors

Neurologisches Rehabilitationszentrum Godeshöhe e.V.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 67 Years

Inclusion criteria

Inclusion criteria: -EDSS (Expanded Disability Status Scale): =5.0 -FSMC total score: =53 -MS phenotype: relapsing-remitting, secondary-progressive -Written informed consent

Exclusion criteria

Exclusion criteria: -Unable to attend water therapy -Comorbidities that prevent attending study therapies -German language skills that interfere with understanding of testing and instructions -Current fatigue medication (Amantadin, Modafinil) started <3 months ago

Design outcomes

Primary

MeasureTime frame
Fatigue 1. Würzburger Erschöpfungsinventar bei Multipler Sklerose (WEIMuS) [Timepoints: admission, discharge, one, four and 12 weeks after discharge] 2. Fatigue Scale for Motor and Cognitive Functions (FSMC) [Timepoints: admission, discharge, one, four and 12 weeks after discharge]

Secondary

MeasureTime frame
Secondary outcomes 1. Cognitive fatigability (Test Battery of Attention Performance – Alertness) [Timepoints: admission, discharge] 2. Motor fatigability (6-minute walk test) [Timepoints: admission, discharge] 3. Cognitive performance (California Verbal Learning Test; Symbol Digit Modalities Test) [Timepoints: admission, discharge] 4. Cardiorespiratory fitness (predicted relative peak oxygen uptake) [Timepoints: admission, discharge] 5. Motor function (Six Spot Step Test; Functional Gait Assessment; Timed 25-foot Walk Test) [Timepoints: admission, discharge] 6. Balance confidence (Activities-Specific Balance Confidence Scale) [Timepoints: admission, discharge] Feasibility outcomes 1. Process (eligibility criteria, recruitment, retention, and refusal rates, adherence, fidelity) 2. Resources (days at baseline assessments, time requirements) 3. Data management (missing items WEIMuS+FSMC, missing assessments at admission and discharge) 4. Acceptability of interventions (adverse events, estimation of treatment effect, session-Rated Perceived Exertion, fun, relevance) 5. Semi-structured interview (study processes, experiences with interventions)

Countries

Germany

Contacts

Public ContactFlorian Wolf

Neurologisches Rehabilitationszentrum Godeshöhe e.V.

f.wolf@godeshoehe.de0228381481

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026