Back to resultsPerformance and Nutrition Program for Athletes in Adaptive Sports
Primary Purpose
Spinal Cord Injuries, Physical Disability
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training & Nutrition
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
Group1 (Group with spinal cord injury):
- Participants with traumatic or non-traumatic spinal cord injury
- Able to perform progressive exercise program
- Willingness to participate in study
Group 2 (Able-bodied group):
- Functional upper extremity range of motion
- Able to perform progressive exercise program
- Willingness to participate in study
Group3 (Other physical disability group):
- Participants with a physical disability other than spinal cord injury
- Able to perform progressive exercise program
- Willingness to participate in study
Exclusion Criteria:
All groups:
• Any documented or reported health condition that would be contraindicated to a progressive exercise program
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training & Nutrition
Arm Description
Participants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks.
Outcomes
Primary Outcome Measures
Change in The World Health Organization Quality of Life Score (WHOQOL-BREF)
The World Health Organization (WHOQOL-BREF) is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life.
Secondary Outcome Measures
Change in exercise self-efficacy score (for participants not living with spinal cord injury)
The Barriers Specific Self-Efficacy Scale is a self-reported survey and was designed to measure subjects' perceived capabilities to exercise even if faced with barriers to exercise. Scores can range from zero to 100 with higher numbers indicating better confidence that the subject has the capability to exercise.
Change in exercise self-efficacy score (for participants living with spinal cord injury)
The Spinal Cord Injury Exercise Self-Efficacy Scale (ESES) is a self-reported survey and includes 10 questions and a maximum score of 40 with higher scores indicating more confidence to exercise.
Change in self-reported un-weighed food records
Self-reported un-weighed food records are collected by participant interview with a registered dietician and also with digital photography of full food plates and left-overs. Improvement in dietary intake is indicated from a "yes" or "no" of whether study participants have met individual goals that are determined during baseline session with dietician.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03392155
Brief Title
Performance and Nutrition Program for Athletes in Adaptive Sports
Official Title
The Effectiveness of a Performance and Nutrition Program for Athletes in Adaptive Sports
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to evaluate and recommend sustainable and effective health and wellness programs for people with spinal cord injury (SCI) and other physical disabilities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Physical Disability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training & Nutrition
Arm Type
Experimental
Arm Description
Participants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Training & Nutrition
Intervention Description
Exercise at moderate to high intensities and diet education/counseling
Primary Outcome Measure Information:
Title
Change in The World Health Organization Quality of Life Score (WHOQOL-BREF)
Description
The World Health Organization (WHOQOL-BREF) is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life.
Time Frame
Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Secondary Outcome Measure Information:
Title
Change in exercise self-efficacy score (for participants not living with spinal cord injury)
Description
The Barriers Specific Self-Efficacy Scale is a self-reported survey and was designed to measure subjects' perceived capabilities to exercise even if faced with barriers to exercise. Scores can range from zero to 100 with higher numbers indicating better confidence that the subject has the capability to exercise.
Time Frame
Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Title
Change in exercise self-efficacy score (for participants living with spinal cord injury)
Description
The Spinal Cord Injury Exercise Self-Efficacy Scale (ESES) is a self-reported survey and includes 10 questions and a maximum score of 40 with higher scores indicating more confidence to exercise.
Time Frame
Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Title
Change in self-reported un-weighed food records
Description
Self-reported un-weighed food records are collected by participant interview with a registered dietician and also with digital photography of full food plates and left-overs. Improvement in dietary intake is indicated from a "yes" or "no" of whether study participants have met individual goals that are determined during baseline session with dietician.
Time Frame
Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Group1 (Group with spinal cord injury):
Participants with traumatic or non-traumatic spinal cord injury
Able to perform progressive exercise program
Willingness to participate in study
Group 2 (Able-bodied group):
Functional upper extremity range of motion
Able to perform progressive exercise program
Willingness to participate in study
Group3 (Other physical disability group):
Participants with a physical disability other than spinal cord injury
Able to perform progressive exercise program
Willingness to participate in study
Exclusion Criteria:
All groups:
• Any documented or reported health condition that would be contraindicated to a progressive exercise program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meegan G Van Straaten
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Performance and Nutrition Program for Athletes in Adaptive Sports
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