Chronic StrokeABCcareNCT06060470
Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
A study testing Virtual reality based dance group in people with Chronic Stroke, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Virtual reality based dance group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 to 90 years of age.
- Able to follow instructions provided in English.
- History of neurological impairment (Stroke) for at least 6 months prior to evaluation (self-report, confirmed by participant's physician).
- Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
- Cognitive skills to actively participate (score of < 26 on Montreal cognitive assessment indicates cognitive impairment).
- Stroke - a) Upper extremity limb function (score of at least 25 on the Fugyl Myer Upper extremity test and Muscle performance grade on deltoid, pec major and and triceps of > or = 2/5).
Who cannot join
- Cognitive or communicative impairment indicated by a score of > 26 on Montreal cognitive assessment and a score of <25 on Mini Mental State Exam Score;
- aphasia <71% on Mississippi Aphasia Screening Test
- >15 on Geriatric Depression Scale.
- unhealed pressure sores,
- active or untreated infection,
- thromboembolic disease,
Show all 22Show fewer
- severe contractures,
- active heterotrophic ossification in the lower extremities,
- lower limb fractures,
- known history of peripheral nerve injury in the lower legs,
- history of cardiovascular or pulmonary complications, or with pacemakers and history of metabolic (endocrine, hepatic) or renal dysfunction, uncontrolled seizures (Self-report).
- History of any acute and significant cardiopulmonary, musculoskeletal or systemic diagnosis in the past 6 months or history of a recent major surgery (<6months) or hospitalization (<3months) and on any sedative drugs.
- Partcipants unavailable for 12 weeks of participation,
- Current participation in other treatment (i.e.- Botox) or other research studies during the phase of the study.
- Pregnancy.
- Uncontrolled pain >3/10 on VAS.
- Complains of shortness of breath
- Uncontrolled hypertension (systolic blood pressure (SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting).
- Resting hear rate (HR) > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) [3].
- Oxygen saturation (measured by pulse oximeter) during resting < 95%.
- Severe cardiac disease (New York Heart Association classification of IIIV) [1]. Exclusion Criteria for Laboratory Slip test.
- T score of < -2 on the Bone density, measured through via the heel ultrasound machine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
Savitha Subramaniam, PhD, 708-291-0471, ssubra26@uic.edu
Jun Ma, MD
About this study
Official title: Mechanism of Action That Underlies an Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming-based therapy to improve overall physical function of community-dwelling individuals with neurological impairments, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain data on compliance and efficacy of a randomized controlled trial. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals.
Read the detailed description
While conventional balance training facilitates balance control and gait functions, the exercises involved in the training are labor-intensive, highly repetitious leading to monotonicity and decreased motivation levels. Therefore, many health care researchers are involved in identifying various methods to reduce the risk of falls addressing the barriers in conventional training methods while having the potential to translate it at home. Pilot studies with dance-based exergaming resulted in improving balance control and cognition post-stroke. Based on this preliminary finding, this current study aimed to identify:
- The evaluate using the randomized controlled trial the efficacy of dance-based exergaming on physical function compared to conventional standard of care (fall prevention and balance training) among people with chronic stroke This pilot studies used Wii-fit Nintendo/ Microsoft Kinect, an off the shelf, commercially available and a cost-effective device that provides similar benefits of exergaming. Community-dwelling people with chronic stroke involved in the study underwent 6 weeks of exergaming or conventional balance training in a tapering manner in a laboratory setting. Participants were assessed for motor and cognitive performance in the laboratory during volitional and reactive balance control while performing a secondary cognitive task. The performance outcome determined the effect on physical function.
- Conditions
- Chronic Stroke
- Being tested
- Virtual reality based dance group, Active Comparator: Control
- Keywords
- Chronic stroke, Dance-based exergaming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality based dance groupBehavioural
Also called Active Balance Cardio (ABC) care
Participants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists.
Active Comparator: ControlBehavioural
Also called Control
Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality based dance group | Experimental | Virtual-reality based dance training - Participants received Virtual-reality based dance training for 10 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) "Just Dance 3". The first six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song. The first 6 weeks are conducted in the laboratory. The next four weeks are conducted in the participants home via telerehabilitation. The four week sessions consisted of 3 sessions/week. Receives: Behavioral: Virtual reality based dance group |
| Control | Active comparator | Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors. Receives: Behavioral: Active Comparator: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to therapy
Total time spent over the intervention duration. In virtual reality-based group a score of thirty two (number of sessions) is the maximum and a score of zero is minimum. While in the Active comparator group: control, ten is the maximum score and zero is the minimum. Higher score indicates increase compliance to therapy.
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Voluntary balance control
Examining maximum center of pressure (CoP) excursion on the Limits of Stability task test using Phyiosensing. Directional control, endpoint excursion, maximum excursion results will be provided in percentage. Maximum percentage being hundred and lowest being 0 percentage. Higher scores better direction, endpoint, and excursion, while lower indicates viceversa.
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Change in Postural Stability
Postural Stability can be defined by simultaneous control of center of mass position and velocity during slip-like perturbation relative to the rear edge of base of support (rear heel). The position normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Greater values indicate greater stability.
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Secondary outcomes (9)
Fall risk
falls efficacy scale questionnaire. Falls Efficacy Scale (FES), an instrument to measure fear of falling, based on the operational definition of this fear as "low perceived self-efficacy at avoiding falls during essential, nonhazardous activities of daily living. A total score of greater than 70 indicates that the person has a fear of falling. Lower scores indicate person has lesser fear of falling.
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Real life falls
Real life falls will be assessed with fall log diary. Higher number indicates increased falls history. Partcipants will be monitored for one year.
Measured: Baseline (week 0) to post-training at home (12 months)
Heart rate variability
Heart rate variability will be assessed by recording HRV, fluctuations of heart rate at specific time intervals using a heart rate monitor test protocol of the Polar® heart rate monitor. Higher scores indicate better autonomic modulation (cardiac function).
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Flow-mediated vasodilatation
Will be evaluated by recording brachial artery flow-mediated vasodilation - FMD; an index of arterial endothelial function with ultrasound imaging (Doppler ultrasound test) of the brachial artery. Flow-mediated vasodilatation results will be provided in percentage. Maximum percentage being hundred and lowest being 0 percentage. Higher percentage indicate higher vascular health.
[Time Frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)].
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Maximal oxygen consumption
Will be assessed using the YMCA submaximal cycle ergometer test explained in the Y's Way to Physical Fitness. Higher scores indicate better aerobic capacity.
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Aerobic capacity
2-minute step test - The 2 Minute Step Test is used to assess an individual's aerobic capacity and evaluate their level of functional fitness. Seps range from 44-116 in health older adults. Higher scores indicate better aerobic endurance.
[Time Frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)].
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Blood pressure
2 mins pre-and post-training. Both systolic and diastolic will be measured.
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Endurance
6-minute walk test - The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes.
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Physical activity
Fitbit-monitored daily steps. Higher number of steps indicate better physical activity..
Measured: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savitha Subramaniam, University of Illinois Chicago
- Investigators
- Savitha Subramaniam, Principal investigator, uic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060470
- Sponsor's protocol ID
- STUDY2023-1087
- Acronym
- ABCcare
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The unidentified data will be shared with all the investigators with the secured system of University of Illinois at Chicago.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action That Underlies an Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06060470
- Acronym / sponsor ID
- ABCcare / STUDY2023-1087
- Conditions
- Chronic Stroke
- Keywords
- Chronic stroke, Dance-based exergaming
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 29 Sep 2023 (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.
Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming-based therapy to improve overall physical function of community-dwelling individuals with neurological impairments, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain data on compliance and efficacy of a randomized controlled trial. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals.
Detailed description
While conventional balance training facilitates balance control and gait functions, the exercises involved in the training are labor-intensive, highly repetitious leading to monotonicity and decreased motivation levels. Therefore, many health care researchers are involved in identifying various methods to reduce the risk of falls addressing the barriers in conventional training methods while having the potential to translate it at home. Pilot studies with dance-based exergaming resulted in improving balance control and cognition post-stroke. Based on this preliminary finding, this current study aimed to identify:
- The evaluate using the randomized controlled trial the efficacy of dance-based exergaming on physical function compared to conventional standard of care (fall prevention and balance training) among people with chronic stroke This pilot studies used Wii-fit Nintendo/ Microsoft Kinect, an off the shelf, commercially available and a cost-effective device that provides similar benefits of exergaming. Community-dwelling people with chronic stroke involved in the study underwent 6 weeks of exergaming or conventional balance training in a tapering manner in a laboratory setting. Participants were assessed for motor and cognitive performance in the laboratory during volitional and reactive balance control while performing a secondary cognitive task. The performance outcome determined the effect on physical function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality based dance group | Experimental | Behavioral: Virtual reality based dance groupVirtual-reality based dance training - Participants received Virtual-reality based dance training for 10 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) "Just Dance 3". The first six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song. The first 6 weeks are conducted in the laboratory. The next four weeks are conducted in the participants home via telerehabilitation. The four week sessions consisted of 3 sessions/week. |
| Control | Active comparator | Behavioral: Active Comparator: ControlParticipants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 45 to 90 years of age.
- Able to follow instructions provided in English.
- History of neurological impairment (Stroke) for at least 6 months prior to evaluation (self-report, confirmed by participant's physician).
- Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
- Cognitive skills to actively participate (score of < 26 on Montreal cognitive assessment indicates cognitive impairment).
Key exclusion criteria (22 listed)
- Cognitive or communicative impairment indicated by a score of > 26 on Montreal cognitive assessment and a score of <25 on Mini Mental State Exam Score;
- aphasia <71% on Mississippi Aphasia Screening Test
- >15 on Geriatric Depression Scale.
- unhealed pressure sores,
- active or untreated infection,
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 |
|---|---|---|
| Virtual reality based dance groupAlso: Active Balance Cardio (ABC) careParticipants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists. | Behavioural | Virtual reality based dance group |
| Active Comparator: ControlAlso: ControlParticipants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors. | Behavioural | Control |
Primary outcome
Compliance to therapy
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Total time spent over the intervention duration. In virtual reality-based group a score of thirty two (number of sessions) is the maximum and a score of zero is minimum. While in the Active comparator group: control, ten is the maximum score and zero is the minimum. Higher score indicates increase compliance to therapy.
Voluntary balance control
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Examining maximum center of pressure (CoP) excursion on the Limits of Stability task test using Phyiosensing. Directional control, endpoint excursion, maximum excursion results will be provided in percentage. Maximum percentage being hundred and lowest being 0 percentage. Higher scores better direction, endpoint, and excursion, while lower indicates viceversa.
Change in Postural Stability
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Postural Stability can be defined by simultaneous control of center of mass position and velocity during slip-like perturbation relative to the rear edge of base of support (rear heel). The position normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Greater values indicate greater stability.
9 secondary outcomes
Fall risk
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Real life falls
Time frame: Baseline (week 0) to post-training at home (12 months)
Heart rate variability
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Flow-mediated vasodilatation
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Maximal oxygen consumption
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Aerobic capacity
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Blood pressure
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Endurance
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Physical activity
Time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. The unidentified data will be shared with all the investigators with the secured system of University of Illinois at Chicago.
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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.
Savitha Subramaniam principal investigator
uic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality based dance group in people with Chronic Stroke, run by University of Illinois Chicago 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 6 inclusion and 22 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: opening soon, as of the sponsor's last update on 18 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Savitha Subramaniam (17082910471, ssubra26@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to therapy (time frame: Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)). The study lists 3 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 18 Oct 2023.