- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06944886
Effects of Active Stretching on Cardiovascular Response and Arterial Stiffness in Older Adults With Low Flexibility (stretching)
Effects of Active Stretching Exercises on Autonomic Cardiovascular Responses and Arterial Stiffness in Elderly Individuals With Low Flexibility Levels: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aims to investigate the effects of active static stretching exercises on autonomic nervous system responses, arterial stiffness, and balance ability in elderly individuals with poor flexibility in the lower extremity muscles.
Participants will engage in an 8-week exercise program consisting of active static stretching sessions, focusing on major muscle groups in the lower limbs. The intervention is designed to improve arterial elasticity and heart rate variability (HRV) while enhancing dynamic and static balance performance.
Outcomes will include measures of heart rate variability (HRV), arterial stiffness, and physical performance assessments such as the Timed Up and Go test (TUG), Single-Leg Stance test (SLST), and muscle strength tests. Body composition and flexibility (sit-and-reach test, back scratch test) will also be evaluated.
The study hypothesizes that active static stretching will promote improvements in autonomic regulation and cardiovascular health, as well as increase flexibility and balance control in community-dwelling older adults with reduced lower-limb flexibility.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Phayao, Thailand, 56000
- Chonticha Kaewjoho
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Elderly males and females
- Have a normal body mass index (between 18.5-24.5 kg/m2)
- Be able to follow instructions and willing to participate in the study
- Be able to communicate with the researcher and provide information by themselves (the researcher will read the questions to the volunteers and let the volunteers choose the answers by themselves)
- Be able to walk continuously for at least 10 meters with or without walking aids
- Have low flexibility with a forward lean distance not exceeding the 40th percentile from the sit and reach test according to the American College of Sports Medicine criteria
Exclusion Criteria:
- - Abnormalities such as pain or inflammation of the legs more than 5 points, assessed by (visual analog scale (VAS) > 5 points)
- Significantly different leg lengths (more than 1.4 centimeters) or abnormalities of joints, including abnormal sensations that affect movement and walking
- Uncontrolled chronic diseases or obstacles to study, such as high blood pressure, diabetes, asthma, neurological diseases such as Parkinson's disease, Alzheimer's disease, skeletal and muscular diseases such as chronic back pain, acute osteoarthritis, sprained ankle
- Vision problems that cannot be corrected by wearing glasses
- Uncorrected hearing Inner ear disturbances that affect balance, such as otitis media
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)
Participants received a pre-intervention orientation at the SHPH, including instruction by a licensed physical therapist on active static stretching and breathing techniques.
Each participant was given an illustrated manual and logbook.
The 8-week program combined home-based stretching with weekly supervised sessions at the SHPH.
Exercises targeted neck, trunk, upper and lower limb muscles (e.g., flexors, extensors, pectorals, triceps, quadriceps, hamstrings, adductors).
Movements were performed in seated, lying, and standing positions, synchronized with breathing.
Each session included a 5-min warm-up, 30 min of stretching, and 5-min cool-down.
Exercises were done 5 times/week (4 at home, 1 supervised).
Community health volunteers followed up weekly.
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Participants in the intervention group performed active static stretching exercises using a pictorial exercise booklet. The booklet contained a series of self-directed stretching postures targeting major muscle groups. Each stretch was held in a static position without external assistance, encouraging the participant to engage and maintain the stretch voluntarily." Each stretch was held for 30 seconds and repeated 3 times per muscle group. The targeted areas included the hamstrings, quadriceps, calves, hip flexors, and shoulders."
Other Names:
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No Intervention: Control group
regular activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart Rate Variability (HRV) Assessment
Time Frame: pre-test, 4weeks and 8 weeks
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HRV was evaluated to measure the variability between heartbeats, providing insight into autonomic nervous system (ANS) function, stress resistance, and arterial elasticity (Nunan et al., 2009).
Measurements were conducted using the SA-3000P device in a temperature-controlled room (25-27 °C) during a consistent morning time frame (8:00-10:00 AM).
Participant data (e.g., sex, date of birth) were entered into the system, and the individual was instructed to sit comfortably, refrain from speaking or moving, and breathe normally for 3 minutes while a finger probe was attached.
Results were automatically displayed and stored for analysis.
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pre-test, 4weeks and 8 weeks
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Timed Up and Go (TUG) Test
Time Frame: pre-test, 4weeks and 8 weeks
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The TUG test was used to assess dynamic balance and fall risk.
Participants were instructed to rise from a chair, walk 3 meters at a safe and fastest possible pace, turn around a cone, and return to the chair.
Timing stopped once they sat back down.
Each participant performed three trials, and the average time was recorded.
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pre-test, 4weeks and 8 weeks
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Hand Grip Strength Test
Time Frame: pre-test, 4weeks and 8 weeks
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Upper extremity strength was assessed using a hand grip dynamometer.
Participants stood upright with arms at their sides.
The test was conducted on the dominant arm with the elbow extended and the arm in a neutral pronated position.
The dynamometer handle was adjusted to the second phalanx.
Participants were asked to abduct the arm approximately 15 degrees and, upon the signal "start," squeeze the device with maximum force.
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pre-test, 4weeks and 8 weeks
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Five Times Sit to Stand Test (FTSST)
Time Frame: pre-test, 4weeks and 8 weeks
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Lower limb strength was assessed using the FTSST.
Participants sat in a standard-height chair (without armrests), feet flat on the floor, heels 10 cm behind the knees, and hips flexed at approximately 90 degrees.
Upon the command "start," they were instructed to stand up and sit down five times as quickly and safely as possible.
Timing began at the command and ended when they sat down on the fifth repetition.
Three trials were conducted, and the average time was used.
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pre-test, 4weeks and 8 weeks
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Single-Leg Stance Test (SLST)
Time Frame: pre-test, 4weeks and 8 weeks
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Static balance was measured using the SLST (Franchignoni et al., 2010).
Participants crossed their arms over their chest and stood on their preferred leg with the opposite leg lifted at 90-degree knee flexion.
Timing started upon command and stopped when any of the following occurred: (1) lifted leg touched the ground, (2) lifted leg touched the standing leg, (3) the standing leg shifted position, or (4) arms moved from the chest.
The test was repeated three times, and the average time (in seconds) was recorded.
Participants were allowed to rest for one minute between trials.
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pre-test, 4weeks and 8 weeks
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Isometric Strength Assessment
Time Frame: pre-test, 4weeks and 8 weeks
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Isometric back, leg, and chest strength was evaluated using a calibrated dynamometer (Takei 5402 Back Muscle Digital Dynamometer).
Participants stood on the device base with knees extended.
The handle height was adjusted to the knee joint.
During testing, participants flexed hips and knees slightly, maintaining a natural lordotic curve.
They were instructed to pull vertically using maximal isometric contraction over 3 seconds, holding for 2 seconds.
After one demonstration and one trial, three formal trials were performed, with 30-second rests in between.
The maximum value from the trials (in kilograms) was recorded for analysis.
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pre-test, 4weeks and 8 weeks
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Sit and Reach Test (SRT)
Time Frame: pre-test, 4weeks and 8 weeks
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Flexibility of the lower back and hamstrings was measured using the SRT.
Participants sat on the floor with knees fully extended and reached forward along a standardized box.
They were instructed to reach as far as possible and hold for two seconds.
Two trials were conducted with 2-minute rests, and the best average score was used
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pre-test, 4weeks and 8 weeks
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Back Scratch Test
Time Frame: pre-test, 4weeks and 8 weeks
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Upper body flexibility was assessed using the Back Scratch Test (ICC: 0.98, 95% CI: 0.97-0.98).
Participants stood upright and reached one hand over the shoulder and the other behind the back to touch or overlap fingertips.
The distance (in cm) between fingertips was measured: overlapping = positive score; unable to touch = negative score; fingertips touching = 0. Two trials were performed for each arm, and the average was recorded.
The minimal detectable change reported in previous studies was 1.41 cm.
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pre-test, 4weeks and 8 weeks
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Body Composition Analysis
Time Frame: pre-test, 4weeks and 8 weeks
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Body composition was assessed using the InBody analyzer, which measures muscle mass, fat, water, minerals, and bone mass via bioelectrical impedance analysis.
Participants grasped the hand electrodes and stood still on the platform for approximately 5 minutes.
The device automatically analyzed and printed the results.
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pre-test, 4weeks and 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chonticha Kaewjoho, PT, PhD Kaewjoho, University of Phayao
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
- UPhayaoChonticha-220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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