Physical DisabilityCHAMPsNCT03768401
Accessible Mobile Health and Wellness
A study testing Education and Trial Exercise Modalities in people with Physical Disability and Neurologic Dysfunction, run by Kristin Zhao, PhD at 1 site in United States.
Trial summary
Can community outreach education help develop self-sustaining wellness and exercise programs, and will associated wellness clinics help persons with a neurological physical disability achieve better well-being? Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Disability, Neurologic Dysfunction
- What is being tested?
- Education and Trial Exercise Modalities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 21 Dec 2018
- 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 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- [for community participants/caregivers/family members] Ability to demonstrate clear communication and understanding of English.
- [for participants with neurological physical conditions] Neurological physical conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis, or similar diagnoses
- [for educational seminars] > 6 years of age.
- [for wellness/exercise clinic] 18 65 years of age
- [for wellness/exercise clinic; participants with neurological physical conditions] Clearance by primary care or treating physician
Who cannot join
- [for participants with neurological physical conditions] Unstable fractures
- [for participants with neurological physical conditions] Uncontrolled hypertension (combined systolic/diastolic > 140/90 mmHg)
- [for participants with neurological physical conditions] Enrollment of individual deemed by study staff to be unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Can community outreach education help develop self-sustaining wellness and exercise programs, and will associated wellness clinics help persons with a neurological physical disability achieve better well-being?
- Conditions
- Physical Disability, Neurologic Dysfunction
- Being tested
- Education, Trial Exercise Modalities
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Seminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability.
Trial Exercise ModalitiesBehavioural
Wellness/exercise clinics located at Mayo Clinic, Rochester will be offered to persons with neurological physical disabilities on a regular basis, at least monthly, during the last half of the trial period.
| Study group | Role | What they receive |
|---|---|---|
| Educational Seminars and Wellness Clinics | Experimental | I. Community outreach educational seminars about wellness and exercise while living with a neurological physical disability and measurement of the effects of these seminars for training individuals with neurological physical disabilities and their care givers (family, therapists, community personal trainers and community funders such as Lions or Rotary Clubs) about how to create a safe cost-effective exercise program .
II. Creation and measurement of the effects of a wellness clinic for those with a neurological physical disability. Receives: Other: Education; Behavioral: Trial Exercise Modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new self-sustaining wellness and exercise programs
Incidence of new self-sustaining wellness and exercise programs, as determined by Follow-up Site Staff Survey
Measured: 3 months post end of wellness clinics
Secondary outcomes (3)
Efficacy of seminars for individuals with a neurological physical disability
Efficacy of seminars, as determined by repeated t-tests based on the Exercise Self-Efficacy Survey (ESES), a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
Measured: 3 months post end of wellness clinics
Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities
Efficacy of seminars, as determined by repeated t-tests based on the Exercise Efficacy for Caregivers and Staff, a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
Measured: 3 months post end of wellness clinics
Efficacy of wellness clinics
Efficacy of wellness clinics, as determined by repeated t-tests
Measured: 3 months post end of wellness clinics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Aug 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Why it stopped: Funding/grant expired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristin Zhao, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Southeastern Minnesota Center for Independent Living
- Responsible party
- Sponsor-investigator, Kristin Zhao, PhD, Mayo Clinic
- Investigators
- Kristin D Zhao, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768401
- Sponsor's protocol ID
- 17-008524
- Acronym
- CHAMPs
- Status last verified
- Apr 2019
- First submitted
- 17 Jul 2018
- Last updated
- 30 Apr 2019
- 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 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessible Mobile Health and Wellness
- ClinicalTrials.gov ID
- NCT03768401
- Acronym / sponsor ID
- CHAMPs / 17-008524
- Conditions
- Physical Disability, Neurologic Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding/grant expired.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Kristin Zhao, PhDUniversity, hospital or other
- Collaborators
- Southeastern Minnesota Center for Independent Living
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 7 Dec 2018 (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.
Can community outreach education help develop self-sustaining wellness and exercise programs, and will associated wellness clinics help persons with a neurological physical disability achieve better well-being?
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Seminars and Wellness Clinics | Experimental | Other: Education, Behavioral: Trial Exercise ModalitiesI. Community outreach educational seminars about wellness and exercise while living with a neurological physical disability and measurement of the effects of these seminars for training individuals with neurological physical disabilities and their care givers (family, therapists, community personal trainers and community funders such as Lions or Rotary Clubs) about how to create a safe cost-effective exercise program . II. Creation and measurement of the effects of a wellness clinic for those with a neurological physical disability. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- [for community participants/caregivers/family members] Ability to demonstrate clear communication and understanding of English.
- [for participants with neurological physical conditions] Neurological physical conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis, or similar diagnoses
- [for educational seminars] > 6 years of age.
- [for wellness/exercise clinic] 18 65 years of age
- [for wellness/exercise clinic; participants with neurological physical conditions] Clearance by primary care or treating physician
Key exclusion criteria (3 listed)
- [for participants with neurological physical conditions] Unstable fractures
- [for participants with neurological physical conditions] Uncontrolled hypertension (combined systolic/diastolic > 140/90 mmHg)
- [for participants with neurological physical conditions] Enrollment of individual deemed by study staff to be unsafe
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 |
|---|---|---|
| EducationSeminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability. | Other | Educational Seminars and Wellness Clinics |
| Trial Exercise ModalitiesWellness/exercise clinics located at Mayo Clinic, Rochester will be offered to persons with neurological physical disabilities on a regular basis, at least monthly, during the last half of the trial period. | Behavioural | Educational Seminars and Wellness Clinics |
Primary outcome
Incidence of new self-sustaining wellness and exercise programs
Time frame: 3 months post end of wellness clinics
Incidence of new self-sustaining wellness and exercise programs, as determined by Follow-up Site Staff Survey
3 secondary outcomes
Efficacy of seminars for individuals with a neurological physical disability
Time frame: 3 months post end of wellness clinics
Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities
Time frame: 3 months post end of wellness clinics
Efficacy of wellness clinics
Time frame: 3 months post end of wellness clinics
Results and safety
The study was stopped early (reason given: Funding/grant expired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Physical Disability
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Recruiting
The STRIVE Before Surgery Trial
Surgery-Complications, Disability Physical
Active, not recruitingObservational study
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Multiple Sclerosis
Not yet recruitingObservational study
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
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.
Kristin D Zhao principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Trial Exercise Modalities in people with Physical Disability and Neurologic Dysfunction, run by Kristin Zhao, PhD 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Apr 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 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?
The study was stopped early (reason given: Funding/grant expired.). Results are not available in the source record.
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?
Incidence of new self-sustaining wellness and exercise programs (time frame: 3 months post end of wellness clinics). 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 30 Apr 2019.