An Eight-week RCT of Home-based Pilates for Symptoms of Anxiety, Depre

An Eight-week Randomised Controlled Trial of Home-based Pilates for Symptoms of Anxiety, Depression, and Fatigue Among People With MS With Minimal-to-mild Mobility Disability: Study Protocol

CompletedNot a drug-phase studyMS (type not specified)NCT04120207

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Home-based Pilates
  • Delayed-start Pilates

What it measured

Main measures

  • Profile of Mood States - Brief Form (POMS-B)

    Baseline

    FatigueMood and sleep

  • Profile of Mood States - Brief Form (POMS-B)

    Week 2

    FatigueMood and sleep

  • Profile of Mood States - Brief Form (POMS-B)

    Week 4

    FatigueMood and sleep

  • Profile of Mood States - Brief Form (POMS-B)

    Week 6

    FatigueMood and sleep

  • Profile of Mood States - Brief Form (POMS-B)

    Week 8

    FatigueMood and sleep

  • State Trait Anxiety Inventory (STAI-Y1)

    Baseline

    Mood and sleep

  • State Trait Anxiety Inventory (STAI-Y1)

    Week 2

    Mood and sleep

  • State Trait Anxiety Inventory (STAI-Y1)

    Week 4

    Mood and sleep

  • State Trait Anxiety Inventory (STAI-Y1)

    Week 6

    Mood and sleep

  • State Trait Anxiety Inventory (STAI-Y1)

    Week 8

    Mood and sleep

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline

    Mood and sleep

  • Hospital Anxiety and Depression Scale (HADS)

    Week 2

    Mood and sleep

  • Hospital Anxiety and Depression Scale (HADS)

    Week 4

    Mood and sleep

  • Hospital Anxiety and Depression Scale (HADS)

    Week 6

    Mood and sleep

  • Hospital Anxiety and Depression Scale (HADS)

    Week 8

    Mood and sleep

  • Quick Inventory of Depressive Symptomatology (QIDS)

    Baseline

    Mood and sleep

  • Quick Inventory of Depressive Symptomatology (QIDS)

    Week 2

    Mood and sleep

  • Quick Inventory of Depressive Symptomatology (QIDS)

    Week 4

    Mood and sleep

  • Quick Inventory of Depressive Symptomatology (QIDS)

    Week 6

    Mood and sleep

  • Quick Inventory of Depressive Symptomatology (QIDS)

    Week 8

    Mood and sleep

  • Modified Fatigue Impact Scale (MFIS)

    Baseline

    Thinking and memoryFatiguePhysical function

  • Modified Fatigue Impact Scale (MFIS)

    Week 2

    Thinking and memoryFatiguePhysical function

  • Modified Fatigue Impact Scale (MFIS)

    Week 4

    Thinking and memoryFatiguePhysical function

  • Modified Fatigue Impact Scale (MFIS)

    Week 6

    Thinking and memoryFatiguePhysical function

  • Modified Fatigue Impact Scale (MFIS)

    Week 8

    Thinking and memoryFatiguePhysical function

Other measures (10)

  • Seven-day Physical Activity Recall Scale (7d-PAR)

    Baseline

    Physical function

  • Seven-day Physical Activity Recall Scale (7d-PAR)

    Week 2

    Physical function

  • Seven-day Physical Activity Recall Scale (7d-PAR)

    Week 4

    Physical function

  • Seven-day Physical Activity Recall Scale (7d-PAR)

    Week 6

    Physical function

  • Seven-day Physical Activity Recall Scale (7d-PAR)

    Week 8

    Physical function

  • Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Baseline

    Walking and mobilityPhysical function

  • Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Week 2

    Walking and mobilityPhysical function

  • Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Week 4

    Walking and mobilityPhysical function

  • Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Week 6

    Walking and mobilityPhysical function

  • Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Week 8

    Walking and mobilityPhysical function

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

Inclusion Criteria: Adults with self-reported, physician-diagnosed Multiple Sclerosis PDDS score \<3 Free from any other significant physical or psychiatric condition Have no previous Pilates experience - Exclusion Criteria: Have any medical contraindications to safe participation in physical activity established by the PAR-Q

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study will investigate the effects of eight-weeks home-based Pilates on symptoms of anxiety, depression, and fatigue among people with Multiple Sclerosis. Half of participants will perform two weekly home-based Pilates sessions guided by a DVD, while the other half will maintain their regular daily activities.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jan 2019

    2. Main results due

      Aug 2019

    3. Finished

      Aug 2019

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