An Eight-week RCT of Home-based Pilates for Symptoms of Anxiety, Depression, and Fatigue Among People With MS

NCT04120207 | Completed

• 1 other identifier: #2017_03_17_EHS
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Pilates; Home-based; Anxiety; Depression; Fatigue

Outcome Measures

Primary Outcomes (25)

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

  The 30-item POMS-B assesses the intensity of feelings of tension, depressed mood, energy and fatigue. Participants respond to each item "based on how you feel RIGHT NOW" using a 5-point Likert scale ranging from 0 (not at all) to 4 (Extremely). Each subscale score ranges from 0-20. The psychometric properties of the POMS-B are well established.

  Baseline

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

  The 30-item POMS-B assesses the intensity of feelings of tension, depressed mood, energy and fatigue. Participants respond to each item "based on how you feel RIGHT NOW" using a 5-point Likert scale ranging from 0 (not at all) to 4 (Extremely). Each subscale score ranges from 0-20. The psychometric properties of the POMS-B are well established.

  Week 2

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

  The 30-item POMS-B assesses the intensity of feelings of tension, depressed mood, energy and fatigue. Participants respond to each item "based on how you feel RIGHT NOW" using a 5-point Likert scale ranging from 0 (not at all) to 4 (Extremely). Each subscale score ranges from 0-20. The psychometric properties of the POMS-B are well established.

  Week 4

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

  The 30-item POMS-B assesses the intensity of feelings of tension, depressed mood, energy and fatigue. Participants respond to each item "based on how you feel RIGHT NOW" using a 5-point Likert scale ranging from 0 (not at all) to 4 (Extremely). Each subscale score ranges from 0-20. The psychometric properties of the POMS-B are well established.

  Week 6

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

  The 30-item POMS-B assesses the intensity of feelings of tension, depressed mood, energy and fatigue. Participants respond to each item "based on how you feel RIGHT NOW" using a 5-point Likert scale ranging from 0 (not at all) to 4 (Extremely). Each subscale score ranges from 0-20. The psychometric properties of the POMS-B are well established.

  Week 8

• State Trait Anxiety Inventory (STAI-Y1)

  The 20-item State and Trait subscales of the widely used and well-validated STAI will assess anxiety. Participants rate each item using a 4-point Likert scale, from 1 "Not at all" to 4 "Very much so". Total score ranges from 20-80; higher scores indicate greater anxiety. The STAI has well-documented psychometric properties in people with MS.

  Baseline

• State Trait Anxiety Inventory (STAI-Y1)

  The 20-item State and Trait subscales of the widely used and well-validated STAI will assess anxiety. Participants rate each item using a 4-point Likert scale, from 1 "Not at all" to 4 "Very much so". Total score ranges from 20-80; higher scores indicate greater anxiety. The STAI has well-documented psychometric properties in people with MS.

  Week 2

• State Trait Anxiety Inventory (STAI-Y1)

  The 20-item State and Trait subscales of the widely used and well-validated STAI will assess anxiety. Participants rate each item using a 4-point Likert scale, from 1 "Not at all" to 4 "Very much so". Total score ranges from 20-80; higher scores indicate greater anxiety. The STAI has well-documented psychometric properties in people with MS.

  Week 4

• State Trait Anxiety Inventory (STAI-Y1)

  The 20-item State and Trait subscales of the widely used and well-validated STAI will assess anxiety. Participants rate each item using a 4-point Likert scale, from 1 "Not at all" to 4 "Very much so". Total score ranges from 20-80; higher scores indicate greater anxiety. The STAI has well-documented psychometric properties in people with MS.

  Week 6

• State Trait Anxiety Inventory (STAI-Y1)

  The 20-item State and Trait subscales of the widely used and well-validated STAI will assess anxiety. Participants rate each item using a 4-point Likert scale, from 1 "Not at all" to 4 "Very much so". Total score ranges from 20-80; higher scores indicate greater anxiety. The STAI has well-documented psychometric properties in people with MS.

  Week 8

• Hospital Anxiety and Depression Scale (HADS)

  The 7-item anxiety and depression subscales of the 14-item HADS measures anxiety and depressive symptoms in the prior week. Subscale scores range from 0-21 with higher scores indicative of greater anxiety and depressive symptoms, and validated cut-scores ≥8 classify anxiety and depression caseness. The HADS has demonstrated reasonable psychometric properties among people with Multiple Sclerosis, demonstrating acceptable sensitivity (90% and 89% for the depression subscale) and specificity (87% and 81% for the anxiety subscale).

  Baseline

• Hospital Anxiety and Depression Scale (HADS)

  The 7-item anxiety and depression subscales of the 14-item HADS measures anxiety and depressive symptoms in the prior week. Subscale scores range from 0-21 with higher scores indicative of greater anxiety and depressive symptoms, and validated cut-scores ≥8 classify anxiety and depression caseness. The HADS has demonstrated reasonable psychometric properties among people with Multiple Sclerosis, demonstrating acceptable sensitivity (90% and 89% for the depression subscale) and specificity (87% and 81% for the anxiety subscale).

  Week 2

• Hospital Anxiety and Depression Scale (HADS)

  The 7-item anxiety and depression subscales of the 14-item HADS measures anxiety and depressive symptoms in the prior week. Subscale scores range from 0-21 with higher scores indicative of greater anxiety and depressive symptoms, and validated cut-scores ≥8 classify anxiety and depression caseness. The HADS has demonstrated reasonable psychometric properties among people with Multiple Sclerosis, demonstrating acceptable sensitivity (90% and 89% for the depression subscale) and specificity (87% and 81% for the anxiety subscale).

  Week 4

• Hospital Anxiety and Depression Scale (HADS)

  The 7-item anxiety and depression subscales of the 14-item HADS measures anxiety and depressive symptoms in the prior week. Subscale scores range from 0-21 with higher scores indicative of greater anxiety and depressive symptoms, and validated cut-scores ≥8 classify anxiety and depression caseness. The HADS has demonstrated reasonable psychometric properties among people with Multiple Sclerosis, demonstrating acceptable sensitivity (90% and 89% for the depression subscale) and specificity (87% and 81% for the anxiety subscale).

  Week 6

• Hospital Anxiety and Depression Scale (HADS)

  The 7-item anxiety and depression subscales of the 14-item HADS measures anxiety and depressive symptoms in the prior week. Subscale scores range from 0-21 with higher scores indicative of greater anxiety and depressive symptoms, and validated cut-scores ≥8 classify anxiety and depression caseness. The HADS has demonstrated reasonable psychometric properties among people with Multiple Sclerosis, demonstrating acceptable sensitivity (90% and 89% for the depression subscale) and specificity (87% and 81% for the anxiety subscale).

  Week 8

• Quick Inventory of Depressive Symptomatology (QIDS)

  The 16-item QIDS will assess depressive symptom severity across nine core criteria for depression, based on the prior week. Participants will rate severity and frequency of specific symptoms experienced in the prior week. Total scores range from 0-27, with a higher score illustrating more symptom severity. Scores \>5 indicate at least mild depression. The QIDS is a valid measure to quantify depressive symptoms with good sensitivity and specificity among people with Multiple Sclerosis.

  Baseline

• Quick Inventory of Depressive Symptomatology (QIDS)

  The 16-item QIDS will assess depressive symptom severity across nine core criteria for depression, based on the prior week. Participants will rate severity and frequency of specific symptoms experienced in the prior week. Total scores range from 0-27, with a higher score illustrating more symptom severity. Scores \>5 indicate at least mild depression. The QIDS is a valid measure to quantify depressive symptoms with good sensitivity and specificity among people with Multiple Sclerosis.

  Week 2

• Quick Inventory of Depressive Symptomatology (QIDS)

  The 16-item QIDS will assess depressive symptom severity across nine core criteria for depression, based on the prior week. Participants will rate severity and frequency of specific symptoms experienced in the prior week. Total scores range from 0-27, with a higher score illustrating more symptom severity. Scores \>5 indicate at least mild depression. The QIDS is a valid measure to quantify depressive symptoms with good sensitivity and specificity among people with Multiple Sclerosis.

  Week 4

• Quick Inventory of Depressive Symptomatology (QIDS)

  The 16-item QIDS will assess depressive symptom severity across nine core criteria for depression, based on the prior week. Participants will rate severity and frequency of specific symptoms experienced in the prior week. Total scores range from 0-27, with a higher score illustrating more symptom severity. Scores \>5 indicate at least mild depression. The QIDS is a valid measure to quantify depressive symptoms with good sensitivity and specificity among people with Multiple Sclerosis.

  Week 6

• Quick Inventory of Depressive Symptomatology (QIDS)

  The 16-item QIDS will assess depressive symptom severity across nine core criteria for depression, based on the prior week. Participants will rate severity and frequency of specific symptoms experienced in the prior week. Total scores range from 0-27, with a higher score illustrating more symptom severity. Scores \>5 indicate at least mild depression. The QIDS is a valid measure to quantify depressive symptoms with good sensitivity and specificity among people with Multiple Sclerosis.

  Week 8

• Modified Fatigue Impact Scale (MFIS)

  The 21-item MFIS is a recommended core outcome measure in exercise studies in people with Multiple Sclerosis, that measures physical, cognitive and psychosocial components of fatigue. Participants respond to "how often fatigue has affected you in this way during the past 4 weeks", using a 5-point Likert scale ranging from 0 (Never) to 4 (Almost Always). Physical subscale scores range from 0 to 36, Cognitive from 0 to 40, and Psychosocial from 0 to 8. Total MFIS scores (0 to 84), is computed by summing physical, cognitive, and psychosocial subscale scores, with a higher score indicating greater impact of fatigue on participant activities. A total fatigue cut-off score of ≥38 distinguishes between fatigued and non-fatigued individual. It has been proposed by the Multiple Sclerosis Council for Clinical Practice Guidelines as a reliable assessment tool of perceived fatigue (1998), with excellent test-retest reliability, and good correlation with the Fatigue Severity Scale.

  Baseline

• Modified Fatigue Impact Scale (MFIS)

  The 21-item MFIS is a recommended core outcome measure in exercise studies in people with Multiple Sclerosis, that measures physical, cognitive and psychosocial components of fatigue. Participants respond to "how often fatigue has affected you in this way during the past 4 weeks", using a 5-point Likert scale ranging from 0 (Never) to 4 (Almost Always). Physical subscale scores range from 0 to 36, Cognitive from 0 to 40, and Psychosocial from 0 to 8. Total MFIS scores (0 to 84), is computed by summing physical, cognitive, and psychosocial subscale scores, with a higher score indicating greater impact of fatigue on participant activities. A total fatigue cut-off score of ≥38 distinguishes between fatigued and non-fatigued individual. It has been proposed by the Multiple Sclerosis Council for Clinical Practice Guidelines as a reliable assessment tool of perceived fatigue (1998), with excellent test-retest reliability, and good correlation with the Fatigue Severity Scale.

  Week 2

• Modified Fatigue Impact Scale (MFIS)

  The 21-item MFIS is a recommended core outcome measure in exercise studies in people with Multiple Sclerosis, that measures physical, cognitive and psychosocial components of fatigue. Participants respond to "how often fatigue has affected you in this way during the past 4 weeks", using a 5-point Likert scale ranging from 0 (Never) to 4 (Almost Always). Physical subscale scores range from 0 to 36, Cognitive from 0 to 40, and Psychosocial from 0 to 8. Total MFIS scores (0 to 84), is computed by summing physical, cognitive, and psychosocial subscale scores, with a higher score indicating greater impact of fatigue on participant activities. A total fatigue cut-off score of ≥38 distinguishes between fatigued and non-fatigued individual. It has been proposed by the Multiple Sclerosis Council for Clinical Practice Guidelines as a reliable assessment tool of perceived fatigue (1998), with excellent test-retest reliability, and good correlation with the Fatigue Severity Scale.

  Week 4

• Modified Fatigue Impact Scale (MFIS)

  The 21-item MFIS is a recommended core outcome measure in exercise studies in people with Multiple Sclerosis, that measures physical, cognitive and psychosocial components of fatigue. Participants respond to "how often fatigue has affected you in this way during the past 4 weeks", using a 5-point Likert scale ranging from 0 (Never) to 4 (Almost Always). Physical subscale scores range from 0 to 36, Cognitive from 0 to 40, and Psychosocial from 0 to 8. Total MFIS scores (0 to 84), is computed by summing physical, cognitive, and psychosocial subscale scores, with a higher score indicating greater impact of fatigue on participant activities. A total fatigue cut-off score of ≥38 distinguishes between fatigued and non-fatigued individual. It has been proposed by the Multiple Sclerosis Council for Clinical Practice Guidelines as a reliable assessment tool of perceived fatigue (1998), with excellent test-retest reliability, and good correlation with the Fatigue Severity Scale.

  Week 6

• Modified Fatigue Impact Scale (MFIS)

  The 21-item MFIS is a recommended core outcome measure in exercise studies in people with Multiple Sclerosis, that measures physical, cognitive and psychosocial components of fatigue. Participants respond to "how often fatigue has affected you in this way during the past 4 weeks", using a 5-point Likert scale ranging from 0 (Never) to 4 (Almost Always). Physical subscale scores range from 0 to 36, Cognitive from 0 to 40, and Psychosocial from 0 to 8. Total MFIS scores (0 to 84), is computed by summing physical, cognitive, and psychosocial subscale scores, with a higher score indicating greater impact of fatigue on participant activities. A total fatigue cut-off score of ≥38 distinguishes between fatigued and non-fatigued individual. It has been proposed by the Multiple Sclerosis Council for Clinical Practice Guidelines as a reliable assessment tool of perceived fatigue (1998), with excellent test-retest reliability, and good correlation with the Fatigue Severity Scale.

  Week 8

Secondary Outcomes (10)

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

  Baseline

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

  Week 2

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

  Week 4

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

  Week 6

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

  Week 8

Study Arms (2)

Home-based Pilates

EXPERIMENTAL

This group will perform two weekly sessions of Pilates 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. 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.

Behavioral: Home-based Pilates

Delayed-Start Control

OTHER

Participants randomized to Delayed-start will 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.

Other: Delayed-start Pilates

Interventions

Home-based Pilates BEHAVIORAL

The Home-based Pilates group will complete two Pilates classes at home, twice weekly, for a period of eight weeks.

Home-based Pilates

Delayed-start Pilates OTHER

The Delayed-start group will maintain their regular daily activities, and be provided with a copy of the Pilates DVD following the intervention, for their own use.

Delayed-Start Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University of Limerick

Limerick, V94 T9PX, Ireland

Location

Related Publications (1)

• 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.

  PMID: 33870785 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Anxiety Disorders; Depression; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew P Herring, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator was blinded to participant allocation, and the analyses were performed blinded to the group. Participants' individual identification numbers assigned at baseline were used during the course of the trial. Following full data extraction from SurveyMonkey.com, identifying information were removed, such that no participant could be identified in the working dataset through one, or a combination of different variables.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Structured PhD Student

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: January 1, 2019
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Primary outcome data will be made available for five years at six months following publication of primary outcome summary data. Secondary outcome data will be made available for five years at six months following publications of secondary outcome summary data.
• Access Criteria: Requestors will be required to sign a Data Access Agreement.

Locations

IE (1)