Performance and Nutrition Program for Athletes in Adaptive Sports

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Physical Disability
• Intervention / Treatment: Behavioral: Training & Nutrition

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training & Nutrition; Participants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks.	Behavioral: Training & Nutrition; Exercise at moderate to high intensities and diet education/counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Meegan G Van Straaten, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 17-005392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No