Clinical trial NCT04120207: An Eight-week RCT of Home-based Pilates for Symptoms of Anxiety, Depression, and Fatigue Among People With MS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Pilates
Home-based
Anxiety
Depression
Fatigue
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This will be a home-based, single blind, randomised, controlled trial comparing immediate-start home-based Pilates with a delayed-start control group. The study protocol was approved by the University Research Ethics Committee. Participants will provide written informed consent prior to testing. The home-based setting promotes national recruitment of participants through the MS Society of Ireland, via distribution of posters and participation information leaflets on social media and text alerts to members. Interested participants will be invited to contact the lead researcher via phone or email, who will answer any study-related questions. Potential participants will be screened for selection criteria over the phone and provided with Participant Information Sheet (PIS), informed consent, Physical Activity Readiness Questionnaire (PAR-Q), and Patient Determined Disease Steps (PDDS) form via post or email. Following screening and initial baseline testing, eligible participants will be randomized to immediate-start home-based Pilates, or delayed-start control, by an independent researcher who will not be involved in outcome assessments, using a computer-generated randomisation tool (www.randomizer.org). The Home-based Pilates group will perform two weekly sessions for eight weeks, completed with at least 48-hours between sessions, in their own home, supported by a DVD developed and previously implemented and evaluated by the lead researcher in a feasibility trial among people with Multiple Sclerosis. The instructor on the DVD is a certified Pilates Instructor. Each participant will receive documented details of the Pilates protocol, along with the DVD which will operate on a DVD player or participant's laptop computer. On activating the DVD, participants will be provided with an opening screen, offering four options to choose from; "Play all" plays the entire contents of the DVD from start to finish; "Warm Up", provides introductory teaching points on the core principles of Pilates along with teaching and demonstration of the Pilates' warm-up exercises; "Main Phase" provides demonstrations and key teaching points of the fourteen Pilates exercise routine, and "Post Stretch" demonstrates and teaches the post-stretch exercises. Each Pilates session will last approximately one hour and is comprised of seven Pilates warm-up exercises and fourteen mat-based beginner's level exercise. Four repetitions of each Pilates movement will be performed during sessions in the first two weeks, with intensity being self-regulated by the participant based on level of physical condition. Repetitions will gradually progress at biweekly intervals, resulting in ten repetitions being performed for the final two weeks of the trial (Weeks 7 and 8). Six post-training stretches will be maintained for a minimum of thirty seconds. Fidelity, adherence, dose and compliance shall be monitored via self-report exercise diaries containing session date, number of repetitions completed per exercise, and session RPE (Rate of perceived exertion), recorded by the participant immediately following session completion. Exercise diaries will be supplemented by a weekly telephone call consisting of direct questions about the frequency, intensity, and duration of the Pilates they have completed and whether they have experienced difficulties with exercise completion, any adverse events or relapses.

The Delayed-Start Control group be instructed to maintain their pre-intervention physical activity levels during the trial and will be contacted by the lead researcher by email or telephone to ensure timely completion of the on-line outcome assessments at biweekly intervals. Following the 8-week intervention, Delayed-Start participants will be provided with the Pilates DVD for their own use, but no data will be collected. For both groups, participants who experience a relapse will be immediately withdrawn from the study, which will be recorded by the lead researcher.

Eligibility 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

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Exclusion Criteria: Have any medical contraindications to safe participation in physical activity established by the PAR-Q

Primary outcomes:
measure: Profile of Mood States - Brief Form (POMS-B)
timeFrame: Baseline
measure: Profile of Mood States - Brief Form (POMS-B)
timeFrame: Week 2
measure: Profile of Mood States - Brief Form (POMS-B)
timeFrame: Week 4
measure: Profile of Mood States - Brief Form (POMS-B)
timeFrame: Week 6
measure: Profile of Mood States - Brief Form (POMS-B)
timeFrame: Week 8
measure: State Trait Anxiety Inventory (STAI-Y1)
timeFrame: Baseline
measure: State Trait Anxiety Inventory (STAI-Y1)
timeFrame: Week 2
measure: State Trait Anxiety Inventory (STAI-Y1)
timeFrame: Week 4
measure: State Trait Anxiety Inventory (STAI-Y1)
timeFrame: Week 6
measure: State Trait Anxiety Inventory (STAI-Y1)
timeFrame: Week 8
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 2
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 4
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 6
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 8
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Baseline
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Week 2
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Week 4
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Week 6
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Week 8
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Week 2
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Week 4
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Week 6
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Week 8
Secondary outcomes:
measure: Seven-day Physical Activity Recall Scale (7d-PAR)
timeFrame: Baseline
measure: Seven-day Physical Activity Recall Scale (7d-PAR)
timeFrame: Week 2
measure: Seven-day Physical Activity Recall Scale (7d-PAR)
timeFrame: Week 4
measure: Seven-day Physical Activity Recall Scale (7d-PAR)
timeFrame: Week 6
measure: Seven-day Physical Activity Recall Scale (7d-PAR)
timeFrame: Week 8
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Baseline
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Week 2
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Week 4
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Week 6
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Week 8
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
Study officials:
affiliation: University of Limerick
name: Matthew P Herring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleming KM, Coote SB, Herring MP. Home-based Pilates for symptoms of anxiety, depression and fatigue among persons with multiple sclerosis: An 8-week randomized controlled trial. Mult Scler. 2021 Dec;27(14):2267-2279. doi: 10.1177/13524585211009216. Epub 2021 Apr 19.