A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment

Completed · Not applicable

Conditions studied: Spinal Cord Injury, Cardiovascular Diseases, Obesity

In brief

This study determines in people with chronic SCI the health and functional impact and user acceptance and satisfaction - of a 6-month comprehensive Lifestyle Intervention; the impact and user acceptance/satisfaction of a Complementary Caregiver Curriculum (CCC) on SCI caregiver health and function and whether the complementary caregiver curriculum (CCC) enhances health and functional benefits obtained by the SCI dyadic partner enrolled in the LI program.

Key facts

Study ID

NCT02853149

Run by

University of Miami

People needed

22

Starts

2016-06-26

Expected to finish

2022-09-23

Last updated by the study team

2022-09-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• a. Inclusion Criteria:
• Men and Women with SCI/D > 1 year, aged 18-70 years.
• American Spinal Injury Association (AIS) Impairment scale A-D Spinal Cord Levels C5-L1
• Any one or more of the following:
• Waist circumference >94 cm (37 inches)
• BMI ≥ 21 kg/m2
• Fasting dyslipidemia (either; High-density lipoprotein cholesterol (HDL-C)≤ 40mg/dL (men)/≤50 mg/dL (women), or Triglycerides (TG) ≥ 150 mg/dL).
• AND,
• Linked with caregivers: Men and women 18-70 years who consent to co-enroll in the study with their partner. Caregivers are defined as: Family member, significant others or friends living with a disabled (SCI/D) partner who provide social and/or physical support including personal assistance, routine emotional encouragement and/or social interaction.

You may not qualify if…

• Exclusion Criteria for Participants with SCI/D:
• Participating in at least 30 minutes of moderate intensity physical activity on at least three days of the week for at least three months.
• Diet involving moderate caloric restriction for at least 6 months resulting in weight loss/gain ≥ 10% of total body mass
• Surgery within 3 months.
• Grade 3-4 pressure ulcer within 3 months;
• limb pain that limits exercise
• recurrent acute infection or illness
• pregnancy
• previous myocardial infarction (MI), or cardiac surgery
• Exclusion Criteria for Caregiver Participants:
• Participating in at least 30 minutes of moderate intensity physical activity on at least three days of the week for at least three months
• Diet involving moderate caloric restriction for at least 6 months.
• weight loss/gain of 10% within the preceding 6 months
• Surgery within 3 months.
• upper limb pain that limits exercise
• pregnancy
• Previous myocardial infarction (MI), cerebrovascular accident (CVA) or cardiac surgery that limits exercise.
• Type I or II diabetes by World Health Organization (WHO) criteria
• Other exclusions applying to groups:
• The following drugs: anti-hyperglycemic agents, and lipid-altering agents within the past 6 months. Women who become pregnant will be advised to notify study personnel, will be tested, and if found to be pregnant discharged from the trial. There is no harm caused by exercise and diet in early pregnancy. Women must wait 6 months after child delivery to enter the study - a criterion of the Diabetes Prevention Program.
• Individuals with a diagnosis of pre-diabetes if, after 2 months of intervention the following diagnostic criteria of the American Diabetes Association criteria (ADA) are observed:
• Fasting Blood Glucose (FBG) 110-126mg/dL after a fast of 8 hours OR 2 hyperglycemia symptoms (i.e. Polyuria, polydipsia and unexplained weight loss) and a causal plasma glucose ≥200 mg/dL. In the absence of unequivocal hyperglycemia, these criteria will be confirmed by repeat testing per (ADA) criteria. Should repeat testing confirm diabetes, subjects will be discharged and referred for medical treatment.

Where it is running

• Craig Hospital — Englewood, Colorado, United States
• University of Miami- The Miami Project to Cure Paralysis — Miami, Florida, United States

Full record on ClinicalTrials.gov

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