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

Primary Purpose

Sarcopenia, High Blood Pressure, Hypertension

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

progressive resistance training

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring cardiovascular disease prevention, muscle weakness, aging, exercise

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Assessment-only control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in blood pressure

change in systolic and diastolic blood pressure

Secondary Outcome Measures

Short Physical Performance Battery (SPPB)

4 meter gait speed (m/s; slow speed indicates lower function), timed five-time-sit-to-stand (in seconds, slower time indicates lower function), 3-stage balance (3 positions total, scored separately; inability to hold each position for 10seconds each indicates lower function)

Timed up and go performance

change in timed up and go (slower time indicates lower function)

Full Information

NCT ID

NCT04255745

First Posted

January 31, 2020

Last Updated

September 19, 2023

Sponsor

University of Illinois at Chicago

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04255745

Brief Title

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

Acronym

INERTIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 27, 2020 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This premise of this K01 proposal is to address current gaps in the literature regarding the understanding of high blood pressure due to sarcopenia, and provide new evidence for the discernible relationship between low muscle strength and blood pressure in sarcopenia, and effective non-pharmaceutical treatment approaches. This study will evaluate the feasibility of recruitment, retention, implementation and adherence to an empirically-based progressive resistance training (PRT) intervention to test its effect on blood pressure in a targeted population of older adults with sarcopenia who are randomized (via block permuted scheme) to the PRT intervention. Built within this randomized control intervention design, the investigators will further explore reversibility to examine whether muscle strength serves as an intervention target for blood pressure control in sarcopenic adults, which will be more appropriately tested in subsequently well-powered R-level intervention studies. Physiologically plausible microvascular mechanisms by which the PRT impacts changes in blood pressure will also be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia, High Blood Pressure, Hypertension

Keywords

cardiovascular disease prevention, muscle weakness, aging, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

permuted block randomization scheme,

Masking

Investigator

Masking Description

Primary investigator will be masked to the outcome data collection

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Assessment-only control

Arm Type

No Intervention

Arm Description

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

progressive resistance training

Intervention Description

Individual, tailored, progressive muscle strength and function intervention

Primary Outcome Measure Information:

Title

Change in blood pressure

Description

change in systolic and diastolic blood pressure

Time Frame

baseline, 12 weeks, 1 year

Secondary Outcome Measure Information:

Title

Short Physical Performance Battery (SPPB)

Description

Time Frame

baseline, 12 weeks, 1 year

Title

Timed up and go performance

Description

change in timed up and go (slower time indicates lower function)

Time Frame

baseline, 12 weeks, 1 year

Other Pre-specified Outcome Measures:

Title

Muscle strength

Description

muscle strength will be assessed using the 1 Repetition maximum test ( the maximum amount of weight a person can hold while performing an exercise safely and maintaining form. the 1RM will be tested on upper and lower body for a total of 6 exercises, as recommended by the American College of Sports Medicine. Changes in 1RM will be reevaluated to see if strength improves. chest press leg press lat-pull down leg extensions shoulder press leg curls

Time Frame

baseline, 8 weeks 12 weeks, 1 year

Title

Microvascular flow-induced vasodilation (FID) dose response

Description

Microvessels in subcutaneous fat (SF) will be extracted from 10 intervention and 5 control subjects (total=15) and isolated for microvascular flow-induced vasodilation (FID). Microvessels will be constricted to physiological and pharmacological pressures (stimuli) followed by dialation by a vasodialtor. The dose response curves to vasodialator will be measured (known as FID dose-response) will be the primary outcome.

Time Frame

baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deepika Laddu, PhD

Organizational Affiliation

UIC

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Illinois at Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34311098

Citation

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.

Results Reference

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

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