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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04255745
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 6, 2020
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Deepika Laddu-Patel, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Sarcopenia High Blood Pressure Hypertension Behavioral: progressive resistance training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: permuted block randomization scheme,
Masking: Single (Investigator)
Masking Description: Primary investigator will be masked to the outcome data collection
Primary Purpose: Treatment
Official Title: The Impact of a Resistance Training Intervention on Blood Pressure Control in Older Adults With Sarcopenia
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Assessment-only control
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.
Experimental: Intervention
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
Individual, tailored, progressive muscle strength and function intervention

Primary Outcome Measures :
  1. Change in systolic and diastolic blood pressure [ Time Frame: baseline, 12 weeks, 1 year ]

Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: baseline, 12 weeks, 1 year ]
    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)

  2. Timed up and go performance [ Time Frame: baseline, 12 weeks, 1 year ]
    change in timed up and go (slower time indicates lower function)

Other Outcome Measures:
  1. Muscle strength [ Time Frame: baseline, 8 weeks 12 weeks, 1 year ]

    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.

    1. chest press
    2. leg press
    3. lat-pull down
    4. leg extensions
    5. shoulder press
    6. leg curls

  2. Microvascular flow-induced vasodilation (FID) dose response [ Time Frame: baseline, 12 weeks ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults (men and women) aged 65 years and older (any racial/ethnic background)
  • Sedentary or low active adults (not active in strength training)

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 (CVD) event or physician diagnosed CVD (heart attack, heart failure, peripheral vascular disease, coronary revascularization, or angina that required overnight hospitalization)
  • Subjects history of mental illness (bipolar, multiple personality disorder), or cognitive impairment (e.g., dementia, Alzheimer's)
  • Subjects with orthopedic pathology or deformity that prevents exercising safely
  • Subjects with active cancer (i.e., recent physician diagnosis, currently receiving treatment, or in remission).
  • Subjects with lupus, multiple sclerosis
  • Lidocaine allergy
  • Participants from the same household as those already enrolled in the study
  • Baseline Montreal Cognitive Assessment score of <22 (adjusted by adding 2 points for education 4-9, 1 point for education 10-12 years)
  • Current participation in another exercise study
  • Currently is- or has a history of abusing alcohol or illicit drugs
  • Subjects who plan to move in the next 6 months or take an extended vacation
  • Non-english speakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04255745

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Contact: Deepika Laddu, PhD 3123552135
Contact: Nidhi Choudhary 312-996-0018

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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Deepika Laddu, PhD    312-355-2135   
Contact: Nidhi Choudhary    312-996-0018   
Sponsors and Collaborators
University of Illinois at Chicago
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: Deepika Laddu-Patel, Assistant Professor, University of Illinois at Chicago Identifier: NCT04255745    
Other Study ID Numbers: 2017-0009
1K01HL148503-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deepika Laddu-Patel, University of Illinois at Chicago:
cardiovascular disease prevention
muscle weakness
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms