The Impact of a Resistance Training Intervention on Blood Pressure Control in Older Adults With Sarcopenia

NCT04255745 | Completed

• 2 other identifiers: 2017-00091K01HL148503-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Current prevention and treatment of high blood pressure (BP) in sarcopenia, by non-pharmacological approaches remain limited and are far from optimal. This randomized control intervention pilot study will provide new evidence of the unexplored relationship between muscle strength and high BP in sarcopenia, and experimentally test the effects of an evidence-based progressive resistance training intervention on BP, while also examining reversibility to identify muscle strength as a non-pharmacological target for BP control in older sarcopenic adults.

Conditions

Sarcopenia; High Blood Pressure; Hypertension

Keywords

cardiovascular disease prevention; aging; exercise; blood pressure; sarcopenia; resistance training; older adults

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

  change in systolic and diastolic blood pressure

  baseline, 12 weeks, 1 year

Secondary Outcomes (2)

• Short Physical Performance Battery (SPPB)

  baseline, 12 weeks, 1 year

• Timed up and go performance

  baseline, 12 weeks, 1 year

Other Outcomes (2)

• Muscle strength

  baseline, 8 weeks 12 weeks, 1 year

• Microvascular flow-induced vasodilation (FID) dose response

  baseline, 12 weeks

Study Arms (2)

Assessment-only control

NO INTERVENTION

30 Assessment-only control group will be mailed (standard or electronic) NIH/National Institutes on Aging (NIA) Go4Life® educational materials once a month for 3 months. Exercise logs documenting weekly exercise activities, duration, time and effort will be requested to be sent back.

Intervention

EXPERIMENTAL

60 Intervention group will receive 12 weeks of supervised resistance training following the American Heart Association and American College of Sports Medicine guidelines for older adults. Exercises will include a mixture of upper-body and lower body strength exercises. Training load will be determined based on initial 1-repetition maximum tests (1-RM). Initial exercise load will start off at low resistance (40-50% 1RM) with more frequent repetitions per exercise, and will gradually increase weight load and intensity over the exercise training period.

Behavioral: progressive resistance training

Interventions

progressive resistance training BEHAVIORAL

Individual, tailored, progressive muscle strength and function intervention

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (men and women) aged 60 years and older (any racial/ethnic background)
• Demonstrates adequate cognitive function by the MoCA (education adjusted score of \>22 at screening)
• Sedentary or low active adults (not active in strength training)
• Resides in the Chicagoland Area
• Able to walk/perform exercise without complete dependence on assisted device
• Able and willing to enroll and provide written informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to 1 of 2 treatment arms, follow through assignment during 3 months active period, participate in 1 follow-up visit at 12 months

You may not qualify if:

• Subjects with self-report of inability to walk at least ¼ mile or walk 400 meters in \<15 minutes without sitting
• Subjects who self-reported having a history of a cardiovascular disease event or physician diagnosed cardiovascular disease (heart attack, heart failure, congenital heart disease, peripheral vascular disease, coronary revascularization, or angina that required overnight hospitalization), cerebrovascular disease (stroke, transient ischemic attack)
• Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 5 years;
• Subjects with orthopedic pathology or deformity that prevents exercising safely
• Diagnosis or history of cognitive impairment (Dementia, Alzheimer's Disease) or bipolar or psychotic disorder or hospitalization for psychological or emotional problems within the last 2 years
• Diagnosis of autoimmune diseases, such as (but not limited to) lupus, multiple sclerosis, advanced/severe rheumatoid arthritis that would preclude exercising safely
• Diagnosis of advanced or severe osteoporosis or orthopedic deformities that may prevent strength training exercise safely
• Participants from the same household as those already enrolled in the study
• Current abuser of alcohol or usage of illicit drugs or history of alcohol or drug abuse
• Planning to move out of the area or take an extended vacation during the study period
• Current or planned participation in in another structured program that overtly focuses on exercise
• Currently enrolled or planning to enroll into another research study that would limit full participation in the study
• Investigator discretion for clinical safety or protocol adherence reasons

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Laddu D, Kim H, Phillips SA, Ma J. INERTIA: A pilot study of the impact of progressive resistance training on blood pressure control in older adults with sarcopenia. Contemp Clin Trials. 2021 Sep;108:106516. doi: 10.1016/j.cct.2021.106516. Epub 2021 Jul 24.

  PMID: 34311098 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Deepika Laddu, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Primary investigator will be masked to the outcome data collection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: permuted block randomization scheme,

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: January 27, 2020
• Primary Completion: June 30, 2024
• Study Completion: May 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)