Performance and Nutrition Program for Athletes in Adaptive Sports

Spinal Cord Injuries Clinical Trial

Official title:

The Effectiveness of a Performance and Nutrition Program for Athletes in Adaptive Sports

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392155
• Other study ID #: 17-005392
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: June 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Disability
• Spinal Cord Injuries

Intervention

Behavioral:
• Training & Nutrition
Exercise at moderate to high intensities and diet education/counseling

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Secondary	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.	Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Secondary	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.	Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)
Secondary	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.	Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)

External Links

•   Mayo Clinic Clinical Trials