Pilates
BehavioralREMOTLY PILATES EXERCISE
NCT Number: NCT07504120
Objectives Objective 1: To determine the effects of a 16-week remotely delivered Pilates intervention on walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS.
Objective 2: To examine the impact of a 16-week remotely delivered Pilates intervention on depression & anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.
Aim Aim 1: To assess whether the 16-week remotely delivered Pilates intervention significantly improves walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS Aim 2: To investigate whether the 16-week remotely delivered Pilates intervention significantly improves depression & anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.
Hypothesis Hypothesis 1: The 16-week remotely delivered Pilates intervention will significantly improve walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS.
Hypothesis 2: Participants receiving the 16-week remotely delivered Pilates intervention will demonstrate significantly greater improvements in depression & anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
The current study will determine the feasibility and efficacy of a 16-week remotely delivered Pilates intervention for improving physical and psychological outcomes, and QOL, compared with a control condition, in individuals with MS. This represents a significant step forward in examining Pilates as an accessible, complementary therapy in MS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
REMOTLY PILATES EXERCISE
Time frame: Baseline and 16 weeks (end of treatment)
Distance walked during the Six-Minute Walk Test (6MWT) will be measured in meters. The outcome is the change from baseline to 16 weeks in 6MWT distance.
Time frame: Baseline and 16 weeks (end of treatment)
Walking speed will be assessed using the Timed 25-Foot Walk (T25FW). The outcome is the change from baseline to 16 weeks in time to walk 25 feet, measured in seconds.
Time frame: Baseline and 16 weeks (end of treatment)
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure of static and dynamic balance. Each item is scored from 0 to 4, and the outcome will be the change from baseline to 16 weeks in the BBS total score (range 0-56), with higher scores indicating better balance and lower risk of falls.
Time frame: Baseline and 16 weeks (end of treatment)
Fatigue will be measured using the Fatigue Severity Scale (FSS), a 9-item questionnaire assessing the impact of fatigue on daily functioning. Each item is rated from 1 to 7, and the outcome will be the change from baseline to 16 weeks in the FSS mean score (range 1-7), with higher scores indicating more severe fatigue.
Time frame: Baseline and 16 weeks (end of treatment)
Pain will be measured using the Short-form McGill Pain Questionnaire (SF-MPQ). The outcome is the change from baseline to 16 weeks in SF-MPQ total score.
Time frame: Baseline and 16 weeks (end of treatment)
Cognitive processing speed will be assessed using the Symbol Digit Modalities Test (SDMT). The outcome is the change from baseline to 16 weeks in SDMT total score, with higher scores indicating better processing speed. SDMT scores typically range from 0 to about 110 correct responses.
Time frame: Baseline and 16 weeks (end of treatment)
Verbal learning and memory will be assessed using the California Verbal Learning Test-II (CVLT-II). The outcome is the change from baseline to 16 weeks in CVLT-II total recall score, with higher scores indicating better verbal learning and memory. CVLT-II total recall scores typically range from 0 to about 80.
Time frame: Baseline and 16 weeks (end of treatment)
Visuospatial learning and memory will be assessed using the Brief Visuospatial Memory Test-Revised (BVMT-R). The outcome is the change from baseline to 16 weeks in BVMT-R total recall score, with higher scores indicating better visuospatial memory. BVMT-R total recall scores typically range from 0 to 36.
Time frame: Baseline and 16 weeks (end of treatment)
Depression will be measured using a validated questionnaire (e.g., the Hospital Anxiety and Depression Scale-Depression subscale or a similar instrument). The outcome is the change from baseline to 16 weeks in depression total score, with higher scores indicating greater depressive symptoms. Typical depression scales have ranges such as 0-21 (HADS-D) ; enter the exact range that matches the scale you are using.
Time frame: Baseline and 16 weeks (end of treatment)
Anxiety will be measured using a validated questionnaire (e.g., the Hospital Anxiety and Depression Scale-Anxiety subscale or a similar instrument). The outcome is the change from baseline to 16 weeks in anxiety total score, with higher scores indicating greater anxiety. Typical anxiety scales have ranges such as 0-21 (HADS-A) or 0-63 (BAI); enter the exact range that matches the scale you are using.
Time frame: Baseline and 16 weeks (end of treatment)
Health-related quality of life will be assessed using a validated questionnaire (e.g., the MSQoL-54 or a comparable instrument). The outcome is the change from baseline to 16 weeks in the quality-of-life total score or composite score. For instruments scored 0-100, higher scores typically indicate better quality of life; specify the exact scoring range and direction according to your chosen measure.
University of Illinois at Chicago
Other
Does Remotely Delivered Pilates Influence Physical and Psychological Outcomes in Individuals With Multiple Sclerosis?
Acronym: MS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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