NCT03768401

Brief 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

July 17, 2018

Last Update Submit

April 28, 2019

Conditions

Physical DisabilityNeurologic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months post end of wellness clinics

Secondary Outcomes (3)

  • Efficacy of seminars for individuals with a neurological physical disability

    3 months post end of wellness clinics

  • Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities

    3 months post end of wellness clinics

  • Efficacy of wellness clinics

    3 months post end of wellness clinics

Study Arms (1)

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.

Other: EducationBehavioral: Trial Exercise Modalities

Interventions

EducationOTHER

Seminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability.

Educational Seminars and Wellness Clinics
Trial Exercise ModalitiesBEHAVIORAL

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.

Educational Seminars and Wellness Clinics

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \[for community participants/caregivers/family members\] 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

You may not qualify if:

  • \[for participants with neurological physical conditions\] 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Neurologic Manifestations

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Kristin D Zhao

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2018

First Posted

December 7, 2018

Study Start

August 1, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)