Multiple SclerosisNCT04120207
An Eight-week RCT of Home-based Pilates for Symptoms of Anxiety, Depression, and Fatigue Among People With MS
A study testing Home-based Pilates and Delayed-start Pilates in people with Multiple Sclerosis, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Home-based Pilates and Delayed-start Pilates
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2019to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Home-based Pilates, Delayed-start Pilates
- Keywords
- Pilates, Home-based, Anxiety, Depression, Fatigue
- Medical subject headings
- Multiple Sclerosis, Anxiety Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based PilatesBehavioural
The Home-based Pilates group will complete two Pilates classes at home, twice weekly, for a period of eight weeks.
Delayed-start PilatesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Delayed-start Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
Secondary outcomes (10)
Seven-day Physical Activity Recall Scale (7d-PAR)
This measures the approximate number of hours the subject slept and how much time they engaged in moderate, hard, and very hard activity. It is a valid measure used extensively in MS research, and has demonstrated high test-retest reliability.
Measured: Baseline
Seven-day Physical Activity Recall Scale (7d-PAR)
This measures the approximate number of hours the subject slept and how much time they engaged in moderate, hard, and very hard activity. It is a valid measure used extensively in MS research, and has demonstrated high test-retest reliability.
Measured: Week 2
Seven-day Physical Activity Recall Scale (7d-PAR)
This measures the approximate number of hours the subject slept and how much time they engaged in moderate, hard, and very hard activity. It is a valid measure used extensively in MS research, and has demonstrated high test-retest reliability.
Measured: Week 4
Seven-day Physical Activity Recall Scale (7d-PAR)
This measures the approximate number of hours the subject slept and how much time they engaged in moderate, hard, and very hard activity. It is a valid measure used extensively in MS research, and has demonstrated high test-retest reliability.
Measured: Week 6
Seven-day Physical Activity Recall Scale (7d-PAR)
This measures the approximate number of hours the subject slept and how much time they engaged in moderate, hard, and very hard activity. It is a valid measure used extensively in MS research, and has demonstrated high test-retest reliability.
Measured: Week 8
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
This is a self-report measure of physical activity in persons with multiple sclerosis. Its validity is well established in MS, and it is sensitive to change following active interventions. Frequency of strenuous (e.g., running or jogging), moderate (e.g., fast walking, easy swimming), and mild (e.g., easy walking) exercise performed for more than 15 minutes during leisure time over a usual week was recorded. Total weekly leisure activity scores were calculated as follows, (strenuous x 9) + (moderate x 5) + (mild x 3). Scores (>=24) indicate activity levels to provide substantial benefits towards overall health contribution.
Measured: Baseline
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
This is a self-report measure of physical activity in persons with multiple sclerosis. Its validity is well established in MS, and it is sensitive to change following active interventions. Frequency of strenuous (e.g., running or jogging), moderate (e.g., fast walking, easy swimming), and mild (e.g., easy walking) exercise performed for more than 15 minutes during leisure time over a usual week was recorded. Total weekly leisure activity scores were calculated as follows, (strenuous x 9) + (moderate x 5) + (mild x 3). Scores (>=24) indicate activity levels to provide substantial benefits towards overall health contribution.
Measured: Week 2
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
This is a self-report measure of physical activity in persons with multiple sclerosis. Its validity is well established in MS, and it is sensitive to change following active interventions. Frequency of strenuous (e.g., running or jogging), moderate (e.g., fast walking, easy swimming), and mild (e.g., easy walking) exercise performed for more than 15 minutes during leisure time over a usual week was recorded. Total weekly leisure activity scores were calculated as follows, (strenuous x 9) + (moderate x 5) + (mild x 3). Scores (>=24) indicate activity levels to provide substantial benefits towards overall health contribution.
Measured: Week 4
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
This is a self-report measure of physical activity in persons with multiple sclerosis. Its validity is well established in MS, and it is sensitive to change following active interventions. Frequency of strenuous (e.g., running or jogging), moderate (e.g., fast walking, easy swimming), and mild (e.g., easy walking) exercise performed for more than 15 minutes during leisure time over a usual week was recorded. Total weekly leisure activity scores were calculated as follows, (strenuous x 9) + (moderate x 5) + (mild x 3). Scores (>=24) indicate activity levels to provide substantial benefits towards overall health contribution.
Measured: Week 6
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
This is a self-report measure of physical activity in persons with multiple sclerosis. Its validity is well established in MS, and it is sensitive to change following active interventions. Frequency of strenuous (e.g., running or jogging), moderate (e.g., fast walking, easy swimming), and mild (e.g., easy walking) exercise performed for more than 15 minutes during leisure time over a usual week was recorded. Total weekly leisure activity scores were calculated as follows, (strenuous x 9) + (moderate x 5) + (mild x 3). Scores (>=24) indicate activity levels to provide substantial benefits towards overall health contribution.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Jan 2019
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Fleming, University of Limerick
- Investigators
- Matthew P Herring, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120207
- Sponsor's protocol ID
- #2017_03_17_EHS
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
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.
PubMed 33870785
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04120207
- Acronym / sponsor ID
- #2017_03_17_EHS
- Conditions
- Multiple Sclerosis
- Keywords
- Pilates, Home-based, Anxiety, Depression, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Home-based Pilates | Experimental | Behavioral: Home-based PilatesThis 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. |
| Delayed-Start Control | Other | Other: Delayed-start PilatesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based PilatesThe Home-based Pilates group will complete two Pilates classes at home, twice weekly, for a period of eight weeks. | Behavioural | Home-based Pilates |
| Delayed-start PilatesThe 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. | Other | Delayed-Start Control |
Primary outcome
Profile of Mood States - Brief Form (POMS-B)
Time frame: Baseline
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.
Profile of Mood States - Brief Form (POMS-B)
Time frame: Week 2
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.
Profile of Mood States - Brief Form (POMS-B)
Time frame: Week 4
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.
Profile of Mood States - Brief Form (POMS-B)
Time frame: Week 6
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.
Profile of Mood States - Brief Form (POMS-B)
Time frame: Week 8
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.
State Trait Anxiety Inventory (STAI-Y1)
Time frame: Baseline
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.
State Trait Anxiety Inventory (STAI-Y1)
Time frame: Week 2
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.
State Trait Anxiety Inventory (STAI-Y1)
Time frame: Week 4
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.
State Trait Anxiety Inventory (STAI-Y1)
Time frame: Week 6
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.
State Trait Anxiety Inventory (STAI-Y1)
Time frame: Week 8
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.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
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).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 2
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).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 4
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).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 6
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).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 8
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).
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Baseline
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.
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Week 2
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.
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Week 4
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.
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Week 6
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.
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Week 8
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.
Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline
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.
Modified Fatigue Impact Scale (MFIS)
Time frame: Week 2
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.
Modified Fatigue Impact Scale (MFIS)
Time frame: Week 4
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.
Modified Fatigue Impact Scale (MFIS)
Time frame: Week 6
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.
Modified Fatigue Impact Scale (MFIS)
Time frame: Week 8
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.
10 secondary outcomes
Seven-day Physical Activity Recall Scale (7d-PAR)
Time frame: Baseline
Seven-day Physical Activity Recall Scale (7d-PAR)
Time frame: Week 2
Seven-day Physical Activity Recall Scale (7d-PAR)
Time frame: Week 4
Seven-day Physical Activity Recall Scale (7d-PAR)
Time frame: Week 6
Seven-day Physical Activity Recall Scale (7d-PAR)
Time frame: Week 8
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Baseline
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Week 2
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Week 4
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Week 6
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 33870785Fleming 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew P Herring, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Pilates and Delayed-start Pilates in people with Multiple Sclerosis, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Mood States - Brief Form (POMS-B) (time frame: Baseline). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.