Bone Marrow TransplantNCT03902210
BMT Online Wellness Study
A study testing Online Yoga and Podcast in people with Bone Marrow Transplant, run by Arizona State University at 1 site in United States.
Trial summary
Specific aim #1: Assess feasibility (i.e., acceptability, practicality, demand, limited efficacy) of a home-based, online yoga intervention in patients following allogeneic stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Transplant
- What is being tested?
- Online Yoga and Podcast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 25 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) have received a bone marrow transplant 6 months ago
- 2) have a cancer diagnosis
- 3) no active infections
- 4) platelet count >50
- 5) answer "no" to all items on the Physical Activity Readiness Questionnaire (PAR-Q), or be willing to obtain a signed medical release from their physician in the case that a question is answered with a "yes"
- 6) have access to a desktop or laptop on a regular basis
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- 7) have access to reliable internet
- 8) read and understand English
- 9) age 18 years or older
- 10) willing to be randomized to one of two groups
Who cannot join
- 1) Engagement in yoga in the past year
- 2) currently engage in ≥150 min/week of moderate-/vigorous-intensity physical activity on a weekly basis
- 3) have a history of syncope in last 2 months
- 4) have a history of recurrent falls (≥2 in 2 months)
- 5) Any planned change in pharmacologic intervention (i.e., new drug) during the study interval (i.e., 20 weeks)
- 6) have an Eastern Cooperative Oncology Group 3 (ECOG 3) questionnaire score greater than three
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- 7) currently utilize Udaya.com
- 8) currently pregnant
- 9) currently reside outside of the United States of America
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Online Wellness Intervention for Bone Marrow Transplant Survivors
Specific aim #1: Assess feasibility (i.e., acceptability, practicality, demand, limited efficacy) of a home-based, online yoga intervention in patients following allogeneic stem cell transplant. Feasibility benchmarks will include: >70% satisfied with the intervention and >70% intending to continue participating in online yoga (i.e., acceptability); >70% of participants achieving an average of >42 min/week (70% of presceibed 60 min/week) of online yoga throughout the 12-week intervention (i.e., demand); >70% completing questionnaires across all four time points (i.e., practicality); at least small effect sizes of the intervention on physical function, fatigue, anxiety, sleep disturbance, social functioning, pain interference, depression, and quality of life as compared to a podcast control group (i.e., limited efficacy).
Read the detailed description
Online Yoga Group: The intervention will be 12-weeks in duration and will consist of a series of pre-approved online yoga classes (6 manufactured specifically for the cancer-afflicted patients instructed by Udaya yoga therapist, Jules Mitchell, MS). Patients will be asked to complete a minimum of 60 minutes per week of yoga practice with encouragement to do more if they can. All Udaya.com videos will include a proper warm-up, cool down, and closing mindfulness activity (i.e., message from yoga therapist, brief meditation, final relaxation). Qualified Udaya yoga instructors who collectively have over 200 years of training and experience will expertly instruct the online yoga classes. Participants will be instructed to view a safety handout (see yoga safety \& modifications handout) before gaining access to the Udaya video library. Yoga therapist, Jules Mitchell and PIs Huberty and Palmer will pre-approve Udaya videos that are appropriate for this population.
A 12-week yoga prescription utilized in previous online yoga studies in MPN patients will be used in the proposed study for BMT patients. The 12-week yoga prescription was designed to be safe and progressive for cancer patients. During the intervention, all classes will offer alternative poses, modifications, and use of props (i.e., yoga blocks and straps) in the instance poses are difficult for the participant (i.e., painful, irregular, uneven breath) and to ensure safety. In addition to specific instruction regarding form and safety, the yoga therapist will provide descriptions of each video that includes tips and modifications to poses (e.g., set the knee on your yoga mat if this feels more comfortable for you). Additionally, patients will also receive a yoga modifications handout outlining the contraindicated yoga poses with modifications (see yoga safety \& modifications handout). This handout will include an exercise warning for patients that experience dizziness, lightheadedness or faintness, excessive shortness of breath, chest pain, and that they need to stop the activity and contact their health care professional immediately if these symptoms are experienced.
The participants will access their yoga prescription on the Udaya.com website using their provided username and password (see instruction document). Participants will be asked to participate in a total of at least 60 minutes of yoga and keep a log of their participation utilizing a daily log available through a REDCap link (see yoga group weekly log). For the entire study, participants will record in their log each time they participate in yoga, the class in which they participated, how long they practiced (start and stop time), their perceived exertion, and their perceived mindfulness. Research staff will provide a weekly reminder email at the beginning of each week encouraging participation in their weekly yoga (see weekly reminder emails). We will ask that participants follow the yoga prescription, but if participants feel they want to deviate from the prescription they have the option to participate in any videos assigned in previous weeks or in any of the additional videos included each week in the prescription.
Podcast Control Group: The podcast control group will be asked to view 60 minutes per week of online podcast videos. The podcast videos will contain general cancer-related health education material. To match the online yoga group for time and attention, 60 minutes per week will be prescribed, however, participants will have the ability to view additional videos each week. Furthermore, participants will also track their podcast video viewing each week in a daily log (see podcast group weekly log) by recording each time they view a video, the video that they viewed, and how long they viewed the video.
- Conditions
- Bone Marrow Transplant
- Being tested
- Online Yoga, Podcast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online YogaBehavioural
60 minutes per week of online yoga through Udaya.com
PodcastBehavioural
60 minutes per week of podcasts
| Study group | Role | What they receive |
|---|---|---|
| Online Yoga | Experimental | The intervention will be 12-weeks in duration and will consist of a series of pre-approved online yoga classes (6 manufactured specifically for the cancer-afflicted patients instructed by Udaya yoga therapist, Jules Mitchell, MS). Patients will be asked to complete a minimum of 60 minutes per week of yoga practice with encouragement to do more if they can. All Udaya.com videos will include a proper warm-up, cool down, and closing mindfulness activity (i.e., message from yoga therapist, brief meditation, final relaxation). Qualified Udaya yoga instructors who collectively have over 200 years of training and experience will expertly instruct the online yoga classes. Participants will be instructed to view a safety handout (see yoga safety \& modifications handout) before gaining access to the Udaya video library. Yoga therapist, Jules Mitchell and PIs Huberty and Palmer will pre-approve Udaya videos that are appropriate for this population. Receives: Behavioral: Online Yoga |
| Podcast | Placebo comparator | The podcast control group will be asked to view 60 minutes per week of online podcast videos. The podcast videos will contain general cancer-related health education material. To match the online yoga group for time and attention, 60 minutes per week will be prescribed, however, participants will have the ability to view additional videos each week. Furthermore, participants will also track their podcast video viewing each week in a daily log (see podcast group weekly log) by recording each time they view a video, the video that they viewed, and how long they viewed the video. Receives: Behavioral: Podcast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function
This measure is captured through the PROMIS-29 Physical Function Subscale. Raw scores can range from 4-20, with higher scores indicating better physical function.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Anxiety
This measure is captured through the PROMIS-29 Anxiety Subscale. Raw scores range from 4-20, with higher scores indicating more anxiety.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Depression
This measure is captured through the PROMIS-29 Depression Subscale. Raw scores range from 4-20, with higher scores indicating more depression.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Fatigue
This measure is captured through the PROMIS-29 Fatigue Subscale. Raw scores range from 4-20, with higher scores indicating more fatigue.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Sleep Disturbance
This measure is captured through the PROMIS-29 Sleep Disturbance Subscale. Raw scores range from 4-20, with higher scores indicating more sleep disturbance.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Ability to Participate in Social Roles and Activities
This measure is captured through the PROMIS-29 Ability to Participate in Social Roles and Activities Subscale. Raw scores range from 4-20, with higher scores indicating a better ability to participate in social roles and activities.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Pain Interference
This measure is captured through the PROMIS-29 Pain Interference Subscale. Raw scores range from 4-20, with higher scores indicating more interference of pain in daily life.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Pain Intensity
This measure is captured through the PROMIS-29 Pain Intensity Subscale. This is a single-item question asking the participant to rate their average level of pain on a 0-10 scale, with a higher score indicating worse pain.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Physical Health
This measure is captured through the PROMIS Global Health Physical Subscale. Raw scores range from 2-10, with higher scores indicating better physical health.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Chronic Graft vs. Host Disease Symptoms
This measure is captured with the Lee Symptom Score, which assesses various symptoms commonly associated with Graft vs. Host Disease. Raw scores range from 0-120, with higher scores indicating higher symptom burden.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Mental Health
This measure is captured through the PROMIS Global Health Mental Health Subscale. Raw scores range from 2-10, with higher scores indicating better mental health.
Measured: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Secondary outcomes (4)
Objective Physical Activity
Objective physical activity will be collected with the Fitbit Flex 2 device. This device captures light, moderate, and vigorous-intensity activity via an accelerometer.
Measured: Daily physical activity throughout the 12-week intervention (baseline through week 12)
Subjective Physical Activity
Subjective physical activity will be assessed with the Modifiable Activity Questionnaire. This questionnaire asks participants to indicate the days and the durations in which they participated in 39 different activities. Weekly minutes of activity is calculated from the information provided.
Measured: Weekly physical activity throughout the 12-week intervention (baseline through week 12)
Objective Yoga/Podcast Participation
Participation in yoga or podcasts is collected through the number of minutes spent viewing/watching/listening to the yoga videos and podcast sessions.
Measured: Weekly throughout the 12-week intervention (baseline through week 12)
Subjective Yoga/Podcast Participation
Participation in yoga or podcasts is collected through self-report yoga or podcast logs.
Measured: Weekly throughout the 12-week intervention (baseline through week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start25 Feb 2019
- Primary completion1 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow TransplantStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Jennifer Huberty, Arizona State University
- Investigators
- Jennifer Huberty, Ph, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902210
- Sponsor's protocol ID
- STUDY00009352
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Wellness Intervention for Bone Marrow Transplant Survivors
- ClinicalTrials.gov ID
- NCT03902210
- Acronym / sponsor ID
- STUDY00009352
- Conditions
- Bone Marrow Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 3 Apr 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.
Specific aim #1: Assess feasibility (i.e., acceptability, practicality, demand, limited efficacy) of a home-based, online yoga intervention in patients following allogeneic stem cell transplant. Feasibility benchmarks will include: >70% satisfied with the intervention and >70% intending to continue participating in online yoga (i.e., acceptability); >70% of participants achieving an average of >42 min/week (70% of presceibed 60 min/week) of online yoga throughout the 12-week intervention (i.e., demand); >70% completing questionnaires across all four time points (i.e., practicality); at least small effect sizes of the intervention on physical function, fatigue, anxiety, sleep disturbance, social functioning, pain interference, depression, and quality of life as compared to a podcast control group (i.e., limited efficacy).
Detailed description
Online Yoga Group: The intervention will be 12-weeks in duration and will consist of a series of pre-approved online yoga classes (6 manufactured specifically for the cancer-afflicted patients instructed by Udaya yoga therapist, Jules Mitchell, MS). Patients will be asked to complete a minimum of 60 minutes per week of yoga practice with encouragement to do more if they can. All Udaya.com videos will include a proper warm-up, cool down, and closing mindfulness activity (i.e., message from yoga therapist, brief meditation, final relaxation). Qualified Udaya yoga instructors who collectively have over 200 years of training and experience will expertly instruct the online yoga classes. Participants will be instructed to view a safety handout (see yoga safety \& modifications handout) before gaining access to the Udaya video library. Yoga therapist, Jules Mitchell and PIs Huberty and Palmer will pre-approve Udaya videos that are appropriate for this population.
A 12-week yoga prescription utilized in previous online yoga studies in MPN patients will be used in the proposed study for BMT patients. The 12-week yoga prescription was designed to be safe and progressive for cancer patients. During the intervention, all classes will offer alternative poses, modifications, and use of props (i.e., yoga blocks and straps) in the instance poses are difficult for the participant (i.e., painful, irregular, uneven breath) and to ensure safety. In addition to specific instruction regarding form and safety, the yoga therapist will provide descriptions of each video that includes tips and modifications to poses (e.g., set the knee on your yoga mat if this feels more comfortable for you). Additionally, patients will also receive a yoga modifications handout outlining the contraindicated yoga poses with modifications (see yoga safety \& modifications handout). This handout will include an exercise warning for patients that experience dizziness, lightheadedness or faintness, excessive shortness of breath, chest pain, and that they need to stop the activity and contact their health care professional immediately if these symptoms are experienced.
The participants will access their yoga prescription on the Udaya.com website using their provided username and password (see instruction document). Participants will be asked to participate in a total of at least 60 minutes of yoga and keep a log of their participation utilizing a daily log available through a REDCap link (see yoga group weekly log). For the entire study, participants will record in their log each time they participate in yoga, the class in which they participated, how long they practiced (start and stop time), their perceived exertion, and their perceived mindfulness. Research staff will provide a weekly reminder email at the beginning of each week encouraging participation in their weekly yoga (see weekly reminder emails). We will ask that participants follow the yoga prescription, but if participants feel they want to deviate from the prescription they have the option to participate in any videos assigned in previous weeks or in any of the additional videos included each week in the prescription.
Podcast Control Group: The podcast control group will be asked to view 60 minutes per week of online podcast videos. The podcast videos will contain general cancer-related health education material. To match the online yoga group for time and attention, 60 minutes per week will be prescribed, however, participants will have the ability to view additional videos each week. Furthermore, participants will also track their podcast video viewing each week in a daily log (see podcast group weekly log) by recording each time they view a video, the video that they viewed, and how long they viewed the video.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Yoga | Experimental | Behavioral: Online YogaThe intervention will be 12-weeks in duration and will consist of a series of pre-approved online yoga classes (6 manufactured specifically for the cancer-afflicted patients instructed by Udaya yoga therapist, Jules Mitchell, MS). Patients will be asked to complete a minimum of 60 minutes per week of yoga practice with encouragement to do more if they can. All Udaya.com videos will include a proper warm-up, cool down, and closing mindfulness activity (i.e., message from yoga therapist, brief meditation, final relaxation). Qualified Udaya yoga instructors who collectively have over 200 years of training and experience will expertly instruct the online yoga classes. Participants will be instructed to view a safety handout (see yoga safety \& modifications handout) before gaining access to the Udaya video library. Yoga therapist, Jules Mitchell and PIs Huberty and Palmer will pre-approve Udaya videos that are appropriate for this population. |
| Podcast | Placebo comparator | Behavioral: PodcastThe podcast control group will be asked to view 60 minutes per week of online podcast videos. The podcast videos will contain general cancer-related health education material. To match the online yoga group for time and attention, 60 minutes per week will be prescribed, however, participants will have the ability to view additional videos each week. Furthermore, participants will also track their podcast video viewing each week in a daily log (see podcast group weekly log) by recording each time they view a video, the video that they viewed, and how long they viewed the video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1) have received a bone marrow transplant 6 months ago
- 2) have a cancer diagnosis
- 3) no active infections
- 4) platelet count >50
- 5) answer "no" to all items on the Physical Activity Readiness Questionnaire (PAR-Q), or be willing to obtain a signed medical release from their physician in the case that a question is answered with a "yes"
Key exclusion criteria (9 listed)
- 1) Engagement in yoga in the past year
- 2) currently engage in ≥150 min/week of moderate-/vigorous-intensity physical activity on a weekly basis
- 3) have a history of syncope in last 2 months
- 4) have a history of recurrent falls (≥2 in 2 months)
- 5) Any planned change in pharmacologic intervention (i.e., new drug) during the study interval (i.e., 20 weeks)
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 |
|---|---|---|
| Online Yoga60 minutes per week of online yoga through Udaya.com | Behavioural | Online Yoga |
| Podcast60 minutes per week of podcasts | Behavioural | Podcast |
Primary outcome
Physical Function
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Physical Function Subscale. Raw scores can range from 4-20, with higher scores indicating better physical function.
Anxiety
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Anxiety Subscale. Raw scores range from 4-20, with higher scores indicating more anxiety.
Depression
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Depression Subscale. Raw scores range from 4-20, with higher scores indicating more depression.
Fatigue
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Fatigue Subscale. Raw scores range from 4-20, with higher scores indicating more fatigue.
Sleep Disturbance
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Sleep Disturbance Subscale. Raw scores range from 4-20, with higher scores indicating more sleep disturbance.
Ability to Participate in Social Roles and Activities
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Ability to Participate in Social Roles and Activities Subscale. Raw scores range from 4-20, with higher scores indicating a better ability to participate in social roles and activities.
Pain Interference
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Pain Interference Subscale. Raw scores range from 4-20, with higher scores indicating more interference of pain in daily life.
Pain Intensity
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS-29 Pain Intensity Subscale. This is a single-item question asking the participant to rate their average level of pain on a 0-10 scale, with a higher score indicating worse pain.
Physical Health
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS Global Health Physical Subscale. Raw scores range from 2-10, with higher scores indicating better physical health.
Chronic Graft vs. Host Disease Symptoms
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured with the Lee Symptom Score, which assesses various symptoms commonly associated with Graft vs. Host Disease. Raw scores range from 0-120, with higher scores indicating higher symptom burden.
Mental Health
Time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
This measure is captured through the PROMIS Global Health Mental Health Subscale. Raw scores range from 2-10, with higher scores indicating better mental health.
4 secondary outcomes
Objective Physical Activity
Time frame: Daily physical activity throughout the 12-week intervention (baseline through week 12)
Subjective Physical Activity
Time frame: Weekly physical activity throughout the 12-week intervention (baseline through week 12)
Objective Yoga/Podcast Participation
Time frame: Weekly throughout the 12-week intervention (baseline through week 12)
Subjective Yoga/Podcast Participation
Time frame: Weekly throughout the 12-week intervention (baseline through week 12)
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 27 Mar 2020.
- Individual participant dataSharing planned: No
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HPC Offered for PRESERVE Expansion
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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.
Jennifer Huberty, Ph principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Yoga and Podcast in people with Bone Marrow Transplant, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. 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 27 Mar 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Physical Function (time frame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2020.