- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812143
Optimizing Strength Training in Older Adults (LOAD)
The objective of the current study is to determine whether lifting lighter loads close to failure improves strength training adaptations and function in older adults. The main questions it aims to answer are:
- The effect of light loads on physical function
- The effect of light loads on muscle mass, power, and strength
Researchers will compare a light-load, high-repetition program to a standard strength training program. Participants will perform supervised strength training twice per week for 20 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anoop T Balachandran, PhD
- Phone Number: 718-997-2729
- Email: athozhuthungalba@qc.cuny.edu
Study Locations
-
-
New York
-
Flushing, New York, United States, 11367
- Recruiting
- Exercise & Aging Lab, Queens College
-
Contact:
- Anoop T Balachandran
- Phone Number: 718-570-0639
- Email: athozhuthungalba@qc.cuny.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females aged 65 years and above
- Inactive lifestyle (< 150 min per week of moderate intensity physical activity) and not regularly participating in a structured strength training program
- Planning to reside in the area for the duration of the study
Exclusion Criteria:
- Severe cardiac disease, including Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Lung disease requiring either oral or injected steroids, or the use of supplemental oxygen
- Short, portable mental status questionnaire with 3 or more errors
- Severe arthritis (either osteoarthritis or rheumatoid arthritis)
- Cancer requiring treatment in the past 1 year (melanomas excluded)
- Development of chest pain or severe shortness of breath during the 6 min self-paced walk test
- Parkinson's disease or other serious neurological disorders
- Renal disease requiring dialysis
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Current consumption of more than 14 alcoholic drinks per week
- Severe lower back or shoulder pain that may worsen with weightlifting exercises
- Undergoing physical therapy involving the lower extremities
- Living in nursing homes, assisted living facilities or other similar institutions
- Currently enrolled in another randomized trial involving a pharmaceutical or lifestyle intervention
- Weight change (intentional or not) over the last 6 months of > 5% of body weight, or plan to lose or gain weight during the study
- Any other cardiovascular, pulmonary, orthopedic, neurologic, or other conditions that would preclude participation and successful completion of the protocol
Temporary Exclusion Criteria
A person meeting any of the following temporary exclusion criteria at the time of screening will not be enrolled but may be re-screened later.
- Severe hypertension, e.g., SBP > 200 mm Hg, DBP > 110 mm Hg
- Major surgery or fracture or hip/knee replacement within the last 6 months
- Hospitalization within the last 6 months (excluding ER visits)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Light Load, High Repetition (LLHR)
The LLHR group will perform a full-body routine with lighter weights, performing 16-20 repetitions per set, close to failure.
|
This intervention involves strength training with lighter loads and higher repetitions.
Other Names:
This intervention involves conventional strength training with higher loads and moderate repetitions.
Other Names:
|
|
Active Comparator: Strength Training (ST)
The ST group will perform a full-body routine with higher weights, performing 8-12 repetitions per set, close to failure.
|
This intervention involves strength training with lighter loads and higher repetitions.
Other Names:
This intervention involves conventional strength training with higher loads and moderate repetitions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-minute walk test
Time Frame: Baseline and week 21
|
Change in the total distance walked in 6 minutes.
The 6-minute walk test is an objective, well-validated, and clinically meaningful measure of physical function in older adults.
|
Baseline and week 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower body muscle power
Time Frame: Baseline and week 21
|
Lower body muscle peak power (W) will be assessed using a pneumatic leg press machine.
|
Baseline and week 21
|
|
Lean body mass (LBM)
Time Frame: Baseline and week 21
|
Change in total lean body mass (kg) will be assessed using a dual-energy X-ray absorptiometry (DXA) scan
|
Baseline and week 21
|
|
Self-reported physical function
Time Frame: Baseline and week 21
|
Self-reported physical function will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function questionnaire.
PROMIS measures are scored on the T-score metric.
High scores mean more of the concept being measured.
|
Baseline and week 21
|
|
Get-up & go test
Time Frame: Baseline and week 21
|
Change in the time (in seconds) taken to complete the get up and go test.
The get up & go test will be used to assess lower body dynamic balance and fall risk
|
Baseline and week 21
|
|
30-second chair stand test
Time Frame: Baseline and week 21
|
Change in the number of repetitions completed during the 30-Second chair stand test.
This test assesses lower body functional strength and power.
|
Baseline and week 21
|
|
Number of participants with adverse events
Time Frame: From enrollment to the end of 20-week intervention period
|
Number of participants experiencing adverse events that are possibly or definitely related to the intervention,
|
From enrollment to the end of 20-week intervention period
|
|
Exercise session attendance
Time Frame: From enrollment to the end of 20-week intervention period
|
The total number of supervised exercise sessions attended by participants over the 20-week intervention period.
|
From enrollment to the end of 20-week intervention period
|
|
Lower body maximal muscle strength
Time Frame: Baseline and week 21.
|
Change in lower body maximum muscle strength will be assessed using a one-repetition maximum (1RM) test on a leg press machine.
|
Baseline and week 21.
|
|
Physical activity enjoyment scale (PACES)
Time Frame: Week 21
|
Participants will complete the 18-item Physical activity enjoyment scale (PACES) to assess their level of physical activity enjoyment.
Scores range from 18 to 126 and higher scores indicate greater enjoyment.
|
Week 21
|
|
Exercise self-efficacy questionnaire
Time Frame: Week 21
|
Participants will complete the exercise self-efficacy scale to assess their belief in their ability to continue strength training twice per week at the prescribed intensity in the future.
Scores range from 0 to 100 and higher scores indicate greater self-efficacy.
|
Week 21
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R15AG085170 (U.S. NIH Grant/Contract)
- 1R15AG085170-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.