- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522398
Acute Power Training Effects in Older Adults (APTE-OA)
Acute Neuromuscular and Physiological Responses to Different Velocity Loss Thresholds During Power Training in Older Adults
The goal of this clinical trial is to learn how older adults respond to power training when the level of fatigue during exercise is different. Power training means performing fast movements with moderate loads to improve strength, power and mobility.
The main questions the study aims to answer are:
- How does the level of fatigue during power training acutely affect strength, movement, and muscle function?
- How does it affect recovery, muscle soreness, and how hard the exercise feels?
Researchers will compare three power-training sessions with different fatigue levels to see which approach may be safest and most effective for older adults.
Participants will be healthy older adults aged 65 to 85 years. Each participant will complete three supervised exercise sessions on a leg press machine. The sessions will take place about one week apart.
During the study, participants will:
- Perform power training on a pneumatic leg press machine
- Complete strength and mobility tests before and after exercise
- Provide small blood samples to measure body responses to exercise
- Rate how hard the exercise feels
- Report muscle soreness for up to two days after exercise
The results may help researchers design safer and more effective power-training programs to improve strength, mobility, and recovery in older adults.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Max Riesbeck, Master of Science
- Phone Number: +32 11 26 84 93
- Email: max.riesbeck@uhasselt.be
Study Contact Backup
- Name: Evelien Van Roie, PhD
- Phone Number: +3211269062
- Email: evelien.vanroie@uhasselt.be
Study Locations
-
-
Flanders
-
Diepenbeek, Flanders, Belgium, 3590
- Recruiting
- REVAL - Faculty of Rehabilitation Sciences
-
Contact:
- Faculteit Revalidatiewetenschappen
- Phone Number: +32(0)11 26 93 11
- Email: reval.rws@uhasselt.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
Participants must:
- Be 65 to 85 years old.
- Be able to live independently and perform everyday activities without help.
- Not have regularly done resistance or strength training in the past year.
- Be able to understand study instructions and communicate in the study language.
- Have a recent statement from their treating physician confirming that their heart and blood vessels are healthy enough to safely take part in this study.
Exclusion criteria
Participants will not be eligible if they have any of the following:
- Unstable heart disease, neurological disease, acute infection, or fever.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, in the 5 days before the study.
- Use of whey protein, casein, or amino acid supplements in the month before the study.
- Acute or chronic injuries to the legs or lower body muscles.
- Any injury or condition that prevents safe leg extension exercises.
- Recent lower-limb joint replacement (less than 6 months ago).
- Dependence on walking aids.
- Current participation in another interventional trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low-Fatigue Power Training (10% velocity loss)
Participants perform a single supervised session of power training on a pneumatic leg press, consisting of 4 sets.
During the exercise, movement speed is continuously monitored.
In this arm, the exercise set will be stopped when movement speed decreases by 10% compared with the fastest repetition, which corresponds to a low level of fatigue (small amount of repetitions).
|
Participants perform supervised power-training exercises on a pneumatic leg press. The sessions are designed to test different levels of fatigue:
Each session lasts a single training bout (4 sets), and is separated from the next session by one week. During and after each session, researchers measure immediate and post 24h responses to the training in neuromuscular function, physiological responses (e.g., blood markers, muscle oxygenation), functional performance, perceived effort, and muscle soreness. This intervention is different from other exercise studies because it focuses on how varying fatigue levels during power training affect immediate performance and recovery in healthy older adults.
Other Names:
|
|
Experimental: Moderate Fatigue Power Training (30% velocity loss)
Participants perform a single supervised session of power training on a pneumatic leg press, consisting of 4 sets.
During the exercise, movement speed is continuously monitored.
In this arm, the exercise set will be stopped when movement speed decreases by 30% compared with the fastest repetition, which corresponds to a moderate level of fatigue (more repetitions, performed closer to muscle failure).
|
Participants perform supervised power-training exercises on a pneumatic leg press. The sessions are designed to test different levels of fatigue:
Each session lasts a single training bout (4 sets), and is separated from the next session by one week. During and after each session, researchers measure immediate and post 24h responses to the training in neuromuscular function, physiological responses (e.g., blood markers, muscle oxygenation), functional performance, perceived effort, and muscle soreness. This intervention is different from other exercise studies because it focuses on how varying fatigue levels during power training affect immediate performance and recovery in healthy older adults.
Other Names:
|
|
Experimental: Cluster-Set Power Training (10% Velocity Loss)
Participants perform a single supervised session of power training on a pneumatic leg press. In this arm, the exercise is organized into 4 cluster sets. A cluster set consists of small groups of repetitions separated by short rest periods within the set. Participants will perform clusters of 3-4 repetitions with 20 seconds of rest between clusters. During the exercise, movement speed is continuously monitored. Each cluster will be performed within the range of 10% velocity loss compared with the fastest repetition, which corresponds to a low level of fatigue. Clusters will continue until the total number of repetitions matches the training volume (amount of total repetitions) reached in the 30% velocity loss condition. This design allows participants to complete a similar total training volume as in the moderate fatigue condition, while maintaining lower fatigue, enabling researchers to separate the effects of exercise volume from the effects of fatigue. |
Participants perform supervised power-training exercises on a pneumatic leg press. The sessions are designed to test different levels of fatigue:
Each session lasts a single training bout (4 sets), and is separated from the next session by one week. During and after each session, researchers measure immediate and post 24h responses to the training in neuromuscular function, physiological responses (e.g., blood markers, muscle oxygenation), functional performance, perceived effort, and muscle soreness. This intervention is different from other exercise studies because it focuses on how varying fatigue levels during power training affect immediate performance and recovery in healthy older adults.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Voluntary Contraction (MVC)
Time Frame: Measurements will be taken before exercise (baseline), 5 minutes after each training session, and 24 hours after each session.
|
Maximum voluntary contraction (MVC) will be assessed to determine the maximum force-generating capacity of the leg extensors using an isokinetic dynamometer (Humac Norm). Simultaneously, muscle activity will be recorded using surface electromyography (EMG; Delsys EMG system). Primary outcome metric: Peak torque (Nm) obtained from three maximal isometric trials recorded on the dynamometer, combined with EMG amplitude (µV) to quantify muscle activation. Interpretation: Higher torque values indicate greater knee extensor strength. EMG amplitude reflects the level of muscle activation during maximal voluntary effort. Interpretation: Higher force values indicate greater leg muscle strength. EMG values indicate the level of muscle activation during the maximal effort. |
Measurements will be taken before exercise (baseline), 5 minutes after each training session, and 24 hours after each session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Torque Development (RTD)
Time Frame: Measurements will be taken before exercise (baseline), 5 minutes after each training session, and 24 hours after each session.
|
Rate of torque development (RTD) will be assessed to determine how quickly participants can generate torque with their leg extensors. This will be measured using an isokinetic dynamometer (Humac Norm), which records joint torque, alongside surface electromyography (EMG; Delsys EMG system), which measures muscle activation. This parameter provides insight into neuromuscular responses to different levels of power training-induced fatigue. Metric: Peak rate of torque development (Nm/s) calculated from three maximal trials, together with EMG amplitude (µV). RTD will be calculated as the slope of the torque-time curve over a specified time interval (e.g., 0-100ms, 100-200 ms). |
Measurements will be taken before exercise (baseline), 5 minutes after each training session, and 24 hours after each session.
|
|
Muscle Activity
Time Frame: Measurements will be taken before exercise (baseline), during exercise session (mean value across the full session), 5 minutes post exercise, and 24 hours post exercise (3 exercise sessions, 1 week apart)
|
Muscle activity will be assessed by recording the electrical signals of the leg muscles during the leg press exercise using surface electromyography (sEMG; Delsys EMG system). This method enables quantification of muscle activation and fatigue-related changes in neuromuscular function. Surface electrodes will be placed on three key thigh muscles: the vastus lateralis, vastus medialis, and biceps femoris. Metric: EMG amplitude (µV), derived from the recorded electrical signals, representing the level of muscle activation during exercise. |
Measurements will be taken before exercise (baseline), during exercise session (mean value across the full session), 5 minutes post exercise, and 24 hours post exercise (3 exercise sessions, 1 week apart)
|
|
Strength Training Data: Mean Movement Velocity
Time Frame: During each exercise session (mean values across the full session) (3 Sessions ; ~1 week apart)
|
Mean concentric movement velocity (meter per second (m/s)) recorded during each leg press (exercise) repetition using the Keiser A400 Leg Press.
|
During each exercise session (mean values across the full session) (3 Sessions ; ~1 week apart)
|
|
Strength Training Data: Power
Time Frame: During each exercise session (mean value across the full session) (3 Sessions ; ~1 week apart)
|
Mean mechanical power (Watts (W)) produced during each leg press repetition recorded by the Keiser A400 Leg Press.
|
During each exercise session (mean value across the full session) (3 Sessions ; ~1 week apart)
|
|
Strength Training Data: Total Number of Repetitions
Time Frame: During each exercise session (mean value across the full session) (3 Sessions ; ~1 week apart)
|
Total number of repetitions (count) completed during each exercise session on the leg press.
|
During each exercise session (mean value across the full session) (3 Sessions ; ~1 week apart)
|
|
Muscle Oxygenation
Time Frame: Baseline (pre-exercise), continuously during each exercise session, 5 minutes post-exercise, and 24 hours post-exercise (for each of the 3 sessions, 1 week apart)
|
Muscle oxygenation will be assessed to determine oxygen availability in the thigh muscle (vastus lateralis) during and after exercise using near-infrared spectroscopy (NIRS). In addition, a vascular occlusion test will be performed to evaluate muscle oxygen extraction and the recovery kinetics of oxygenation following transient blood flow restriction. Metric: Muscle oxygen saturation (%; e.g., SmO₂), as well as reoxygenation rate and amplitude following occlusion. |
Baseline (pre-exercise), continuously during each exercise session, 5 minutes post-exercise, and 24 hours post-exercise (for each of the 3 sessions, 1 week apart)
|
|
Blood Lactate
Time Frame: Measurements will be taken at baseline and immediately post exercise session (3 sessions, 1 week apart)
|
Small blood sample will be taken to measure lactate, in millimoles per liter analysed through standard laboratory tests, including Enzyme-Linked Immunosorbent Assay (ELISA).
|
Measurements will be taken at baseline and immediately post exercise session (3 sessions, 1 week apart)
|
|
Blood Gas
Time Frame: Measurements will be taken at baseline and immediately post exercise session (3 sessions, 1 week apart).
|
A Small blood sample will be taken to measure blood gas levels (blood oxygen/carbon dioxide levels) using standard laboratory tests, including Enzyme-Linked Immunosorbent Assay (ELISA).
|
Measurements will be taken at baseline and immediately post exercise session (3 sessions, 1 week apart).
|
|
Creatine Kinase (CK)
Time Frame: Measurements will be taken at Baseline and 24 hours after each exercise session.
|
Small blood samples will be taken to measure creatine kinase (CK), an enzyme that increases in the blood when muscles are damaged or stressed. Metric: CK concentration in units per liter (U/L). |
Measurements will be taken at Baseline and 24 hours after each exercise session.
|
|
Functional Performance: Five-Repetition Sit-to-Stand Test
Time Frame: Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
Five-Repetition Sit-to-Stand (5xSTS) test: Participants stand up from a chair repeatedly.
An inertial measurement unit (DynaPort MoveTest, McRoberts, The Hague, NL) measures speed (meters per second (m/s)), movement duration (s) , and power (W).
|
Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
|
Functional Performance: Counter Movement Jump
Time Frame: Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
Countermovement Jump (CMJ): Participants jump vertically from a standing position.
Jump height (cm), force (Nm), and power (W) are measured using KINVENT force plates.
|
Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
|
Functional Performance: Stair Ascent test
Time Frame: Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
Stair Ascent Test (SA): Participants climb a set of stairs while wearing an inertial measurement unit (DynaPort MoveTest, McRoberts, The Hague, NL), which measures speed (m/s), movement duration (s), distance (cm), and power (W).
|
Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
|
Functional Performance: 30-s Sit-to-Stand Test
Time Frame: Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
30-Second Sit-to-Stand (30sSTS) Tests: Participants stand up from a chair repeatedly.
An inertial measurement unit (DynaPort MoveTest, McRoberts, The Hague, NL) measures speed (m/s), movement duration (s), and power (W).
|
Measurements will be taken at Baseline, immediate post exercise and 24 hours after each exercise session.
|
|
Perceived Exertion
Time Frame: Assessed after each exercise set during each exercise session (mean value across the full session) (3 Sessions ; ~1 week apart)
|
Perceived exertion will be assessed using the OMNI Resistance Exercise Scale (OMNI-RES).
Participants will rate their level of effort after each exercise set during the leg press sessions.
The scale ranges from 1 (no exertion at all) to 10 (maximum effort), with higher scores indicating greater perceived exertion.
|
Assessed after each exercise set during each exercise session (mean value across the full session) (3 Sessions ; ~1 week apart)
|
|
Delayed Onset Muscle Soreness (DOMS)
Time Frame: Ratings will be collected at baseline, 24 hours after exercise, and 48 hours after exercise using a remote survey.
|
Delayed onset of muscle soreness (DOMS) will be assessed using a Visual Analog Scale (VAS).
Participants will rate perceived soreness in the leg muscles on a scale from 0 (no soreness) to 10 (worst possible soreness), with higher scores indicating greater muscle soreness.
|
Ratings will be collected at baseline, 24 hours after exercise, and 48 hours after exercise using a remote survey.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Evelien Van Roie, PhD, Hasselt University, Faculty of Rehabilitation Sciences
- Principal Investigator: Bruno Tassignon, PhD, Hasselt University, Faculty of Rehabilitation Sciences
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Other Study ID Numbers
- B1152025000035
- BOF25OWB22 (Other Grant/Funding Number: BOF)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Only qualified researchers affiliated with recognized academic or research institutions will be eligible. Researchers must submit a formal request describing the purpose and planned analyses. The research proposal must relate to legitimate scientific questions consistent with the original study aims. The proposed statistical methods must be clearly described.
Researchers submit a data access request through the study's contact point or the FAIRVault platform. Once approved, they will sign a Data Transfer Agreement (DTA) before receiving access to the data. All requests will be reviewed by the study team or designated independent reviewers to ensure the research is appropriate, the data will be handled responsibly, and privacy protections are met.
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
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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