NCT03392155

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

December 26, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

December 26, 2017

Last Update Submit

June 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in exercise self-efficacy score (for participants not living with spinal cord injury)

    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)

    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

    Baseline (during week 1-2 of study), After intervention (week 16), 12 weeks after completion of study (week 28)

Study Arms (1)

Training & Nutrition

EXPERIMENTAL

Participants receive performance training twice a week for 12 weeks and group and individual nutritional counseling during the 12 weeks.

Behavioral: Training & Nutrition

Interventions

Exercise at moderate to high intensities and diet education/counseling

Training & Nutrition

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • All groups:
  • Any documented or reported health condition that would be contraindicated to a progressive exercise program

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

Spinal Cord Injuries

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Meegan G Van Straaten

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 5, 2018

Study Start

January 9, 2018

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

June 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations