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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL148503-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| progressive resistance training | Behavioral | Individual, tailored, progressive muscle strength and function intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | change in systolic and diastolic blood pressure | baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepika Laddu, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34311098 | Result | 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. |
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After enrollment, study eligibility was confirmed via hand grip strength assessment. Clinically meaningful weakness will determine study eligibility is defined as a grip strength <30kg in men and <20kg in women. Adults who do not meet the cutoff for low sex-specific grip strength were ineligible to continue.
Recruitment dates: 01/27/2020 through September 2022. Recruitment was temporarily paused from 03/06/2020 through July 2020 due to the COVID pandemic and university mandated closures of research. Recruitment resumed in August 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. progressive resistance training: Individual, tailored, progressive muscle strength and function intervention |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Assessment-only Control | 21 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Blood Pressure | change in systolic and diastolic blood pressure | patients were hypertensive and taking blood pressure lowering medication. Prescription data was collected at baseline but not during follow up. | Posted | Mean | Standard Deviation | mmHg | baseline, 12 weeks |
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Adverse events were collected for during the 12 week intervention period for those who initiated the intervention.
Deaths and adverse events were only monitored/assessed for those who initiated the intervention (n=71). i.e., out of the 77 randomized, we do not report on the 6 (5 intervention; 1 control) who withdrew during Covid, prior to them starting the intervention; therefore total monitored= 71.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assessment-only Control | 21 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. |
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The total number of participants enrolled was 77. However, this study started a few weeks prior to COVID-19 and state-mandated shutdowns, during which 6 participants withdrew from the study due to pandemic-related changes and vulnerabilities. Therefore, we report on 71 participants who initiated their assigned condition following re-opening of research.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepika Laddu, Associate Professor | Northwestern University | 312-503-4827 | dladdu@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2022 | Mar 23, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2023 | May 6, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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permuted block randomization scheme,
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Primary investigator will be masked to the outcome data collection
| Intervention |
50 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. progressive resistance training: Individual, tailored, progressive muscle strength and function intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| body mass index | Mean | Standard Deviation | kg per meters squared |
|
| grip strength | Mean | Standard Deviation | kg |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Intervention | 50 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. progressive resistance training: Individual, tailored, progressive muscle strength and function intervention | 0 | 45 | 0 | 45 | 0 | 45 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |