StrokeStrokeStrongNCT02322411
Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke
A study testing Isometric Progressive Resistance Oropharyngeal Therapy and Compensatory approaches in people with Stroke, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall goal of this randomized controlled pilot study is to characterize effects of SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO) therapy in a dose response framework on swallowing-related outcomes in a group of unilateral ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Stroke
- What is being tested?
- Isometric Progressive Resistance Oropharyngeal Therapy and Compensatory approaches
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 19 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of unilateral ischemic strokes by attending physician (according to the National Institute of Health Stroke Scale (NIHSS))
- within 6 months of acute stroke diagnosis
- a score of 3 or higher on the Penetration-Aspiration scale OR a score of 2 on the Residue scale at any location (oral cavity, valleculae, or pharynx) that is instrumentally documented by a participating SLP during a standardized videofluoroscopic swallowing study
- between the ages of 21 and 95
- ability to perform the strengthening protocol independently or with the assistance of a caregiver
- physician approval of medical stability to participate
Show all 9Show fewer
- decision-making capacity to provide informed consent (confirmed through discussion with the subject's primary physician)
- phone access
- ability to return to the clinic for required follow-up appointments.
Who cannot join
- degenerative neuromuscular disease
- prior or current diagnosis of bilateral or hemorrhagic stroke
- prior surgery to the head and neck region that would affect muscles involved in swallowing
- history of radiotherapy or chemotherapy to the head and neck
- patient unable to complete the exercise program
- taking medications that depress the central nervous system
- allergy to barium (used in videofluoroscopic swallowing assessment)
- currently pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53562
About this study
Official title: Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal (I-PRO) Therapy on Dysphagia Related Outcomes in Patients Post-stroke
The overall goal of this randomized controlled pilot study is to characterize effects of SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO) therapy in a dose response framework on swallowing-related outcomes in a group of unilateral ischemic stroke patients. These results will be used to determine adequate sample size in order to support a larger clinical trial focused on the efficacy of this therapy approach for improving swallowing safety. The first aim is to determine differences in swallowing physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects undergoing SwallowSTRONG® DF I-PRO therapy and controls and b) between 8 and 12 weeks of treatment. The second aim is to examine changes in level of oral intake and swallowing quality of life in post-stroke patients undergoing DF I-PRO therapy as compared to a control group and as they relate to treatment duration response at 8 weeks and 12 weeks. The third aim is to evaluate effects of DF I-PRO therapy on overall health status reflected by the number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects undergoing DF I-PRO therapy compared to controls.
Read the detailed description
Dysphagia is estimated to occur in up to 76% of acute stroke patients1,2 and by 2030 the prevalence of stroke is estimated to rise by 21%.3 Serious health complications may result from the presence of dysphagia following stroke, including the development of aspiration pneumonia, malnutrition, and mortality.4-6 Developing pneumonia post-stroke results in a significantly increased relative risk (2.99) of death within 30 days of hospital discharge.1 Compensatory approaches to intervention, including postures or diet modification, are commonly used but do not enact lasting change in swallowing function. Early and intensive therapy approaches are suggested for attainment of optimal swallowing outcomes.7 The tongue is the primary propulsive force for movement of the bolus through the oral cavity and pharynx and into the cervical esophagus during swallowing. Patients post-stroke demonstrate lower than normal maximum isometric lingual pressures, measured as pressures produced when the tongue is pushed as hard as possible against the palate.2 Progressive resistance training for the tongue and related oropharyngeal musculature has been shown to improve swallow physiology and quality of life for patients post-stroke.8 Previous studies have examined Isometric Progressive Resistance Oropharyngeal (I-PRO) therapy facilitated by the Iowa Oral Pressure Instrument (IOPI) for lingual strengthening. The recently developed SwallowSTRONG® device consists of a customized, adjustable mouthpiece that provides pressure readings from embedded sensors allowing for consistent tongue placement, immediate knowledge of performance levels, and automatic calculation of therapeutic strengthening targets. Results from a federally-funded Department of Veterans Affairs Clinical Demonstration Program that employed use of device-facilitated (DF) I-PRO therapy showed improved swallowing-related outcomes in a group of patients with oropharyngeal dysphagia resulting from a variety of medical etiologies.9 The effects of this therapy approach on various aspects of swallowing function and health status in a group of post-stroke patients have yet to be examined. In addition, ideal treatment duration for use with stroke patients is unknown.
The long term goal of this work is to develop more effective, evidence-based treatments that improve overall health status related to swallowing-specific changes for patients with dysphagia. The preliminary group data generated will provide the basis for a line of work dedicated to determination of effective treatments for patients post-stroke.
Specific Aims include: 1) determine differences in swallowing physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects undergoing DF I-PRO therapy and a control group and b) between two durations of treatment (8 and 12 weeks); 2) examine changes in level of oral intake and swallowing quality of life in post-stroke patients undergoing I-PRO therapy as compared to a control group and as they relate to treatment duration response at 8 weeks and 12 weeks; and 3) evaluate effects of DF I-PRO therapy on overall health status reflected by the number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects undergoing DF I-PRO therapy compared to controls.
In order to address these aims, thirty patients who have suffered unilateral ischemic stroke will be recruited. Subjects will be randomized to receive either 1) 12 weeks of DF I-PRO therapy plus compensatory treatment or 2) compensatory treatment only. Assessments will take place at baseline, 8 and 12 weeks. The primary outcome measure will be changes in maximum isometric tongue pressures. Details regarding specific outcomes most influenced by this approach and dose response effects will inform the clinical practice of Speech-Language Pathologists and facilitate strengthening regimens to become more standard for the treatment of stroke related dysphagia.
- Conditions
- Stroke
- Being tested
- Isometric Progressive Resistance Oropharyngeal Therapy, Compensatory approaches
- Keywords
- Stroke, Deglutition, Deglutition disorders, Resistance training
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Progressive Resistance Oropharyngeal TherapyDevice
Also called SwallowStrong device
Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device.
Compensatory approachesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Compensatory | Active comparator | This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Receives: Behavioral: Compensatory approaches |
| I-PRO + compensatory | Experimental | The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Receives: Device: Isometric Progressive Resistance Oropharyngeal Therapy; Behavioral: Compensatory approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures)
Changes in the one repetition maximum isometric lingual pressures measured at the front and back sensors of the device
Measured: After 8 weeks and 12 weeks
Secondary outcomes (6)
Percent Residue
Measurement of Residue
Measured: baseline, 8 and 12 weeks
Swallowing-related Pressures (Videofluoroscopic Swallow Study)
Pressures will be measured while the subject is swallowing during the videofluoroscopic swallow study
Measured: After 8 and 12 weeks
Dysphagia-related Quality of Life Scores (SWAL-QOL)
A quality of life questionnaire related to swallowing. The scores range from 0-100, and a higher score indicates a higher quality of life related to swallowing.
Measured: After 8 weeks and 12 weeks
Functional Oral Intake Scale (FOIS) Scores
FOIS scores reflect level of nutritional intake. Scores range from 1 to 7, with 1 being nothing by mouth and with 7 indicating a diet with no restrictions. Qualitative assessment via interview. Range of final scores is between 1 and 7. Average scores of each arm reported at 8 and 12 weeks.
Measured: After 8 weeks and 12 weeks
Pneumonia Diagnoses (Number of Pneumonia Diagnoses)
The number of pneumonia diagnoses within 9 months following completion of the program will be compared to the same pre-enrollment period.
Measured: up to 9 months
Hospital Admissions (Number of Hospital Admissions and Readmissions)
The number of hospital admissions and readmissions within 9 months following completion of the program will be compared to the same pre-enrollment period.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion19 Oct 2017
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Pulia, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322411
- Sponsor's protocol ID
- 2014-0747
- Other IDs
- A534255, SMPH/MEDICINE/GER-AD DEV
- Acronym
- StrokeStrong
- Status last verified
- Jul 2020
- First submitted
- 17 Dec 2014
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Krekeler BN, Yee J, Kurosu A, Osman F, Pena-Chavez R, Leverson G, Young B, Sattin J, Knigge M, Thibeault S, Rogus-Pulia N. Effects of Device-Facilitated Lingual Strengthening Therapy on Dysphagia Related Outcomes in Patients Post-Stroke: A Randomized Controlled Trial. Dysphagia. 2023 Dec;38(6):1551-1567. doi: 10.1007/s00455-023-10583-0. Epub 2023 May 17.
PubMed 37195518
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal (I-PRO) Therapy on Dysphagia Related Outcomes in Patients Post-stroke
- ClinicalTrials.gov ID
- NCT02322411
- Acronym / sponsor ID
- StrokeStrong / 2014-0747
- Conditions
- Stroke
- Keywords
- Stroke, Deglutition, Deglutition disorders, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this randomized controlled pilot study is to characterize effects of SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO) therapy in a dose response framework on swallowing-related outcomes in a group of unilateral ischemic stroke patients. These results will be used to determine adequate sample size in order to support a larger clinical trial focused on the efficacy of this therapy approach for improving swallowing safety. The first aim is to determine differences in swallowing physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects undergoing SwallowSTRONG® DF I-PRO therapy and controls and b) between 8 and 12 weeks of treatment. The second aim is to examine changes in level of oral intake and swallowing quality of life in post-stroke patients undergoing DF I-PRO therapy as compared to a control group and as they relate to treatment duration response at 8 weeks and 12 weeks. The third aim is to evaluate effects of DF I-PRO therapy on overall health status reflected by the number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects undergoing DF I-PRO therapy compared to controls.
Detailed description
Dysphagia is estimated to occur in up to 76% of acute stroke patients1,2 and by 2030 the prevalence of stroke is estimated to rise by 21%.3 Serious health complications may result from the presence of dysphagia following stroke, including the development of aspiration pneumonia, malnutrition, and mortality.4-6 Developing pneumonia post-stroke results in a significantly increased relative risk (2.99) of death within 30 days of hospital discharge.1 Compensatory approaches to intervention, including postures or diet modification, are commonly used but do not enact lasting change in swallowing function. Early and intensive therapy approaches are suggested for attainment of optimal swallowing outcomes.7 The tongue is the primary propulsive force for movement of the bolus through the oral cavity and pharynx and into the cervical esophagus during swallowing. Patients post-stroke demonstrate lower than normal maximum isometric lingual pressures, measured as pressures produced when the tongue is pushed as hard as possible against the palate.2 Progressive resistance training for the tongue and related oropharyngeal musculature has been shown to improve swallow physiology and quality of life for patients post-stroke.8 Previous studies have examined Isometric Progressive Resistance Oropharyngeal (I-PRO) therapy facilitated by the Iowa Oral Pressure Instrument (IOPI) for lingual strengthening. The recently developed SwallowSTRONG® device consists of a customized, adjustable mouthpiece that provides pressure readings from embedded sensors allowing for consistent tongue placement, immediate knowledge of performance levels, and automatic calculation of therapeutic strengthening targets. Results from a federally-funded Department of Veterans Affairs Clinical Demonstration Program that employed use of device-facilitated (DF) I-PRO therapy showed improved swallowing-related outcomes in a group of patients with oropharyngeal dysphagia resulting from a variety of medical etiologies.9 The effects of this therapy approach on various aspects of swallowing function and health status in a group of post-stroke patients have yet to be examined. In addition, ideal treatment duration for use with stroke patients is unknown.
The long term goal of this work is to develop more effective, evidence-based treatments that improve overall health status related to swallowing-specific changes for patients with dysphagia. The preliminary group data generated will provide the basis for a line of work dedicated to determination of effective treatments for patients post-stroke.
Specific Aims include: 1) determine differences in swallowing physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects undergoing DF I-PRO therapy and a control group and b) between two durations of treatment (8 and 12 weeks); 2) examine changes in level of oral intake and swallowing quality of life in post-stroke patients undergoing I-PRO therapy as compared to a control group and as they relate to treatment duration response at 8 weeks and 12 weeks; and 3) evaluate effects of DF I-PRO therapy on overall health status reflected by the number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects undergoing DF I-PRO therapy compared to controls.
In order to address these aims, thirty patients who have suffered unilateral ischemic stroke will be recruited. Subjects will be randomized to receive either 1) 12 weeks of DF I-PRO therapy plus compensatory treatment or 2) compensatory treatment only. Assessments will take place at baseline, 8 and 12 weeks. The primary outcome measure will be changes in maximum isometric tongue pressures. Details regarding specific outcomes most influenced by this approach and dose response effects will inform the clinical practice of Speech-Language Pathologists and facilitate strengthening regimens to become more standard for the treatment of stroke related dysphagia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compensatory | Active comparator | Behavioral: Compensatory approachesThis group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. |
| I-PRO + compensatory | Experimental | Device: Isometric Progressive Resistance Oropharyngeal Therapy, Behavioral: Compensatory approachesThe Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- clinical diagnosis of unilateral ischemic strokes by attending physician (according to the National Institute of Health Stroke Scale (NIHSS))
- within 6 months of acute stroke diagnosis
- a score of 3 or higher on the Penetration-Aspiration scale OR a score of 2 on the Residue scale at any location (oral cavity, valleculae, or pharynx) that is instrumentally documented by a participating SLP during a standardized videofluoroscopic swallowing study
- between the ages of 21 and 95
- ability to perform the strengthening protocol independently or with the assistance of a caregiver
Key exclusion criteria (8 listed)
- degenerative neuromuscular disease
- prior or current diagnosis of bilateral or hemorrhagic stroke
- prior surgery to the head and neck region that would affect muscles involved in swallowing
- history of radiotherapy or chemotherapy to the head and neck
- patient unable to complete the exercise program
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 |
|---|---|---|
| Isometric Progressive Resistance Oropharyngeal TherapyAlso: SwallowStrong deviceIsometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. | Device | I-PRO + compensatory |
| Compensatory approaches | Behavioural | Compensatory, I-PRO + compensatory |
Primary outcome
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures)
Time frame: After 8 weeks and 12 weeks
Changes in the one repetition maximum isometric lingual pressures measured at the front and back sensors of the device
6 secondary outcomes
Percent Residue
Time frame: baseline, 8 and 12 weeks
Swallowing-related Pressures (Videofluoroscopic Swallow Study)
Time frame: After 8 and 12 weeks
Dysphagia-related Quality of Life Scores (SWAL-QOL)
Time frame: After 8 weeks and 12 weeks
Functional Oral Intake Scale (FOIS) Scores
Time frame: After 8 weeks and 12 weeks
Pneumonia Diagnoses (Number of Pneumonia Diagnoses)
Time frame: up to 9 months
Hospital Admissions (Number of Hospital Admissions and Readmissions)
Time frame: up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37195518Krekeler BN, Yee J, Kurosu A, Osman F, Pena-Chavez R, Leverson G, Young B, Sattin J, Knigge M, Thibeault S, Rogus-Pulia N. Effects of Device-Facilitated Lingual Strengthening Therapy on Dysphagia Related Outcomes in Patients Post-Stroke: A Randomized Controlled Trial. Dysphagia. 2023 Dec;38(6):1551-1567. doi: 10.1007/s00455-023-10583-0. Epub 2023 May 17.
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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.
Nicole Pulia, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Progressive Resistance Oropharyngeal Therapy and Compensatory approaches in people with Stroke, run by University of Wisconsin, Madison 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 9 inclusion and 8 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 15 Jul 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. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures) (time frame: After 8 weeks and 12 weeks). 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 NCT02322411, 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 15 Jul 2020.