Weight Loss and ExeRcise for Post-stroke Veterans

NCT06322030 | Recruiting

• 3 other identifiers: N4281-RRX004281PRO0120848
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke.

Conditions

Stroke

Keywords

obesity; weight loss; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in distance walk in 6 minute Walk Test

  Distance walk in 6 minutes

  approximately 15 weeks

Secondary Outcomes (4)

• Change in daily step activity

  approximately 15 weeks

• Change in score of Stroke Impact Scale (SIS)

  approximately 15 weeks

• Change in score of Sheehan Disability Scale (SDS)

  approximately 15 weeks

• Change in score of Inventory of Psychosocial Functioning (IPF)

  approximately 15 weeks

Other Outcomes (2)

• Change in blood lipid profile

  approximately 15 weeks

• Change in body composition in Dual-energy x-ray absorptiometry

  approximately 15 weeks

Study Arms (4)

Diet

EXPERIMENTAL

15 week weight management program

Dietary Supplement: FOCUS-15 Lifestyle Management Program

Control

NO INTERVENTION

waitlist control

Exercise

EXPERIMENTAL

exercise training

Behavioral: Exercise Training

Diet + Exercise

EXPERIMENTAL

15 week weight management program + exercise training

Dietary Supplement: FOCUS-15 Lifestyle Management Program; Behavioral: Exercise Training

Interventions

FOCUS-15 Lifestyle Management Program DIETARY_SUPPLEMENT

15 week weight management program

Also known as: Diet

Diet; Diet + Exercise

Exercise Training BEHAVIORAL

15 weeks of progressive exercise training

Diet + Exercise; Exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of stroke at least 6 months prior
• BMI \> 30 kg/m2
• Residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
• Ability to follow instructions, complete training and testing and to communicate exertion, pain and distress
• Provision of informed consent

You may not qualify if:

• Unable to ambulate at least 150 feet or experienced intermittent claudication while walking
• Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
• Dementia
• Life expectancy \<1 yr
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
• Current enrollment in a rehabilitation trial to enhance motor or psychosocial recovery

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Obesity; Weight Loss

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chris M Gregory, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah A Jackson, BA MA

CONTACT

(843) 789-6700; sarah.jackson@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The coordinator will not see group assignment, only a patient number which is entered into a software package.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will utilize a 2x2 factorial design to assess for changes in our outcomes over time between treatment groups.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)