- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07398092
TRX Suspension Training for Sarcopenia in Older Men (TRX-SARC)
Effects of TRX Suspension Training on Physical Fitness, Gait Performance, and Inflammatory and Growth-Related Biomarkers in Older Men With Sarcopenia: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of a 12-week TRX suspension training program on physical fitness, gait performance, and selected blood biomarkers in older men with sarcopenia. Sarcopenia is an age-related condition characterized by loss of muscle mass, muscle strength, and physical function, which increases the risk of falls, disability, and reduced quality of life.
A total of 36 older men diagnosed with sarcopenia were randomly assigned to either a TRX suspension training group or a control group. The training group participated in supervised TRX exercise sessions three times per week for 12 weeks, with each session lasting approximately 60 minutes. The control group maintained their usual daily activities without structured exercise intervention.
Physical fitness, walking ability, and blood biomarkers related to inflammation and muscle growth were assessed before and after the intervention. The study aimed to determine whether TRX suspension training is a safe and effective exercise approach for improving muscle strength, balance, walking ability, and biological indicators associated with sarcopenia in older adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was a single-center, randomized controlled trial designed to examine the effects of TRX suspension training on physical fitness, gait performance, and inflammatory- and growth-related biomarkers in older men with sarcopenia.
Eligible participants were men aged 65 years and older who met established diagnostic criteria for sarcopenia based on low handgrip strength, reduced skeletal muscle mass index, and slow gait speed. After screening, 36 participants were randomly allocated in a 1:1 ratio to either an experimental group receiving TRX suspension training or a control group maintaining usual daily activities.
The intervention consisted of a 12-week TRX suspension training program conducted three times per week. Each training session lasted approximately 60 minutes and included a warm-up period, a main training phase, and a cool-down period. The exercise program emphasized multi-joint, whole-body movements targeting the upper limbs, lower limbs, and trunk. Training intensity and difficulty were progressively adjusted using body angle and support-point principles to ensure safety and individualized progression for older participants.
Assessments were performed before the intervention and within 48 hours after completion of the 12-week program. Outcome measures included physical fitness tests (upper- and lower-limb muscle strength, balance, and agility), gait performance tests (mobility, walking speed, and walking endurance), and fasting blood biomarkers related to inflammation and muscle growth, including interleukin-6, tumor necrosis factor-alpha, insulin-like growth factor-1, C-reactive protein, and vitamin D.
The primary objective of the study was to determine whether TRX suspension training could improve muscle strength and functional mobility in older men with sarcopenia. Secondary objectives included evaluating changes in gait performance and selected biological markers associated with inflammation and muscle metabolism. This study aimed to provide evidence supporting the use of TRX suspension training as a safe and effective exercise strategy for improving physical function and reducing fall risk in older adults with sarcopenia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sichuan
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Yibin, Sichuan, China, 644000
- Yibin University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male participants aged 65 years or older.
- Diagnosis of sarcopenia based on established criteria, including low handgrip strength, reduced skeletal muscle mass index, and slow gait speed.
- Ability to walk independently without assistive devices.
- Ability to understand the study procedures and provide written informed consent.
- Willingness to participate in the 12-week intervention and complete all required assessments.
Exclusion Criteria:
- Presence of severe cardiovascular disease or other medical conditions that contraindicate moderate-intensity exercise.
- Diagnosis of severe depression, dementia, or other neurological or psychiatric disorders that could interfere with participation.
- Participation in other structured exercise or training programs during the study period.
- History of drug or alcohol abuse.
- Any musculoskeletal, neurological, or systemic condition that would prevent safe participation in the exercise intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TRX Suspension Training Group
Participants assigned to this arm received a supervised TRX suspension training program for 12 weeks.
Training sessions were conducted three times per week, with each session lasting approximately 60 minutes.
The program included progressive, whole-body resistance exercises targeting the upper limbs, lower limbs, and trunk.
|
TRX suspension training was delivered as a structured, supervised exercise program conducted three times per week for 12 weeks.
Each session lasted approximately 60 minutes and included warm-up, main training, and cool-down phases.
The program emphasized progressive, whole-body resistance exercises targeting the upper limbs, lower limbs, and trunk, with training intensity individualized through adjustments in body angle and support points.
|
|
Other: Control Group
Participants in the control group maintained their usual daily activities throughout the 12-week study period and did not participate in any structured exercise or training intervention.
|
Participants continued their usual daily activities during the 12-week study period and did not receive any structured exercise or training intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Handgrip Strength
Time Frame: Baseline to 12 weeks
|
Handgrip strength was measured using a digital handgrip dynamometer.
The primary outcome was the change in maximal handgrip strength from baseline to the end of the 12-week intervention period.
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Baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 30-Second Chair Stand Test Performance
Time Frame: Baseline to 12 weeks
|
Lower-limb muscle strength was assessed using the 30-second chair stand test.
The outcome was defined as the change in the number of completed stands from baseline to the end of the 12-week intervention.
|
Baseline to 12 weeks
|
|
Change in 30-Second Arm Curl Test Performance
Time Frame: Baseline to 12 weeks
|
Upper-limb muscular endurance was evaluated using the 30-second arm curl test.
The outcome was the change in the number of repetitions completed from baseline to the end of the 12-week intervention period.
|
Baseline to 12 weeks
|
|
Change in Single-Leg Stance Time
Time Frame: Baseline to 12 weeks
|
Static balance was assessed using the single-leg stance test.
The outcome was defined as the change in maximal standing time from baseline to the end of the 12-week intervention.
|
Baseline to 12 weeks
|
|
Change in Four Square Step Test Performance
Time Frame: Baseline to 12 weeks
|
Dynamic balance and agility were evaluated using the four square step test.
The outcome was the change in completion time from baseline to the end of the 12-week intervention period.
|
Baseline to 12 weeks
|
|
Change in Timed Up and Go Test Performance
Time Frame: Baseline to 12 weeks
|
Functional mobility was assessed using the Timed Up and Go test.
The outcome was defined as the change in test completion time from baseline to the end of the 12-week intervention.
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Baseline to 12 weeks
|
|
Change in 10-Meter Walk Test Performance
Time Frame: Baseline to 12 weeks
|
Walking speed was evaluated using the 10-meter walk test.
The outcome was defined as the change in walking time from baseline to the end of the 12-week intervention period.
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Baseline to 12 weeks
|
|
Change in Six-Minute Walk Test Distance
Time Frame: Baseline to 12 weeks
|
Walking endurance was assessed using the six-minute walk test.
The outcome was defined as the change in total walking distance from baseline to the end of the 12-week intervention.
|
Baseline to 12 weeks
|
|
Change in Serum Interleukin-6 Levels
Time Frame: Baseline to 12 weeks
|
Systemic inflammation was evaluated by measuring fasting serum interleukin-6 concentrations.
The outcome was defined as the change in IL-6 levels from baseline to the end of the 12-week intervention.
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Baseline to 12 weeks
|
|
Change in Serum Tumor Necrosis Factor-Alpha Levels
Time Frame: Baseline to 12 weeks
|
Inflammatory status was assessed by measuring fasting serum tumor necrosis factor-alpha concentrations.
The outcome was defined as the change in TNF-alpha levels from baseline to the end of the 12-week intervention.
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Baseline to 12 weeks
|
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Change in Serum Insulin-Like Growth Factor-1 Levels
Time Frame: Baseline to 12 weeks
|
Muscle anabolic status was assessed by measuring fasting serum insulin-like growth factor-1 concentrations.
The outcome was defined as the change in IGF-1 levels from baseline to the end of the 12-week intervention.
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Baseline to 12 weeks
|
|
Change in Serum Vitamin D Levels
Time Frame: Baseline to 12 weeks
|
Vitamin D status was evaluated by measuring fasting serum vitamin D concentrations.
The outcome was defined as the change in vitamin D levels from baseline to the end of the 12-week intervention.
|
Baseline to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seung-Soo Baek, PhD, Department of Sport and Healthcare, Sangmyung University, Seoul, Republic of Korea
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YBU-TRX-SARC-2024-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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