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

NCT02853149 | Completed

• 2 other identifiers: 2015106590DP0074-01-00
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Spinal Cord Injury; Cardiovascular Diseases; Obesity

Keywords

Spinal Cord Injury; disability; obesity; cardiometabolic; Caregiver

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Fitness indicators as measured by Body Mass index (BMI)-

  Body Mass index will be calculated with the respective formula after collecting Height (supine position) and weight (calibrated scale), expressed in kg/m2

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months.

Secondary Outcomes (6)

• Change from baseline in Cardioendocrine and Global Cardiovascular risk by surrogate blood measures of the Homeostasis Model Assessment -Insulin Resistance (HOMA 2-IR) in SCI individuals and caregivers (unitless)

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

• Change from baseline in Cardioendocrine and Global Cardiovascular risk by surrogate blood measures of the Total Cholesterol(TC): High Density high-density lipoprotein(HDL) ratio in SCI individuals and caregivers

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

• Change in Inflammatory state cytokines by surrogate blood measures in SCI and Caregivers of Interleukin 6 (IL-6) and Interleukin (IL-1) tests

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

• Change in Inflammatory state cytokines by surrogate blood measures in SCI and Caregivers of Tumor necrosis factor alpha (TNF-α)

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

• Change from baseline in Fitness indicators as measured by Endurance-maximal oxygen consumption (Vo2 peak test)individuals and their caregivers

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

Other Outcomes (5)

• Change from baseline in Multi-dimensional Pain-The West Haven-Yale Multi-dimensional Pain Inventory (MPI-SCI)

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

• Change from baseline in Caregiver Function- Patient-Reported Outcomes Measurement Information System (PROMIS)

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

• Change from baseline in Basic Pain and Classification after SCI -The International SCI Basic Pain Data Set (ISCIBPDS)

  -2 Months (Wash) to Baseline (0 Months); to 6 Months and 12 Months and Baseline (0 months) to 6 Months and 12 Months

Study Arms (3)

Spinal Cord Injury (SCI)

EXPERIMENTAL

Experimental: Lifestyle Intervention This arm will examine whether a twelve month treatment program (one year) for Spinal Cord injury individuals enrolled with their caregivers, can lower body weight, reduce body fat, reduce risk factors for developing heart disease and diabetes, and improve the quality of life using a 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.

Behavioral: Spinal Cord Injury (SCI)

Caregiver Intervention(CCC)

ACTIVE COMPARATOR

Lifestyle Intervention This arm will examine whether a twelve month treatment program (one year) enrolled with their Care-receivers( SCI individuals) can lower body weight, reduce body fat, reduce risk factors for developing heart disease and diabetes, and improve the quality of life using a 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.

Behavioral: Caregiver Intervention(CCC)

Caregiver Control (CC)

PLACEBO COMPARATOR

Placebo: This arm will examine whether a twelve month treatment program (one year) enrolled with their Care-receivers( SCI individuals) can lower body weight, reduce body fat, reduce risk factors for developing heart disease and diabetes, and improve the quality of life. The control group intervention will test benefits of exercise alone while controlling for investigator contact.

Behavioral: Caregiver Control (CC)

Interventions

Spinal Cord Injury (SCI) BEHAVIORAL

The SCI Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or "extension phase" in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program.

Also known as: Lifestyle program-SCI

Spinal Cord Injury (SCI)

Caregiver Intervention(CCC) BEHAVIORAL

The Caregiver Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or "extension phase" in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program.

Also known as: Lifestyle program-Caregiver Intervention CCC

Caregiver Intervention(CCC)

Caregiver Control (CC) BEHAVIORAL

The Caregiver Control group will also discuss ways in which health and fitness can be improved through exercise and nutrition and will also be offered a fully paid membership to the an exercise fitness center to encourage them to exercise and consume a healthy diet. Unlike the Caregiver Intervention group(CCC) the lifestyle recommendations will be provided by internet authorities such as Web Medical(WebMD), the US Department of Agriculture, and the US Department of Human Health Services, which are dependable websites that promote healthy ways of living.

Also known as: CC

Caregiver Control (CC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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
• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (2)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

University of Miami- The Miami Project to Cure Paralysis

Miami, Florida, 33129, United States

Location

Related Publications (3)

• Bigford GE, Lehmann DA, Betancourt LF, Maher JL, Mendez AJ, Nash MS. Modification of the Diabetes Prevention Program Lifestyle Intervention in Persons with Spinal Cord Injury: Efficacy for Reducing Major Cardiometabolic Risks, Increased Fitness, and Improved Health-Related Quality of Life. J Spine Res Surg. 2024;6(1):10.26502/fjsrs0070. doi: 10.26502/fjsrs0070.

  PMID: 39309246 DERIVED

• Bigford GE, Lehmann DA, Mendez AJ, Nash MS. The Impact of Caregiver/Care-Receiver Co-Treatment in a Therapeutic Lifestyle Intervention for Chronic Spinal Cord Injury: A Comparative Case Series. Ann Case Rep. 2024;9(2):10.29011/2574-7754.101755. doi: 10.29011/2574-7754.101755.

  PMID: 39308936 DERIVED

• Bigford GE, Betancourt LF, Charlifue S, Nash MS. Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment: A Study Protocol of a Multisite Randomized Controlled Trial. Int J Environ Res Public Health. 2023 Sep 25;20(19):6819. doi: 10.3390/ijerph20196819.

  PMID: 37835090 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Cardiovascular Diseases; Obesity

Interventions

Creb3l2 protein, rat

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark S Nash, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Neurological Surgery and Physical Medicine & Rehabilitation

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: June 26, 2016
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)