Arterial StiffnessstretchingNCT06944886
Effects of Active Stretching on Cardiovascular Response and Arterial Stiffness in Older Adults With Low Flexibility
A study testing Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group) in people with Arterial Stiffness and Autonomic Nervous System, run by University of Phayao at 1 site in Thailand.
Trial summary
A study of the effects of active static stretching exercise in elderly people with poor lower extremity muscle flexibility on autonomic and cardiovascular responses and balance ability. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, Autonomic Nervous System, Musculoskeletal Diseases
- What is being tested?
- Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2024to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Active Stretching Exercises on Autonomic Cardiovascular Responses and Arterial Stiffness in Elderly Individuals With Low Flexibility Levels: A Randomized Controlled Trial
A study of the effects of active static stretching exercise in elderly people with poor lower extremity muscle flexibility on autonomic and cardiovascular responses and balance ability.
Read the 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.
- Being tested
- Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)
- Keywords
- Active static stretching, Arterial stiffness, Autonomic nervous system response, Lower-limb flexibility, Balance control in older adults
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)Other
Also called Active Static Stretching
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."
| Study group | Role | What they receive |
|---|---|---|
| Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group) | Experimental | 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. Receives: Other: Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group) |
| Control group | No intervention | regular activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV) Assessment
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.
Measured: pre-test, 4weeks and 8 weeks
Timed Up and Go (TUG) Test
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.
Measured: pre-test, 4weeks and 8 weeks
Hand Grip Strength Test
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.
Measured: pre-test, 4weeks and 8 weeks
Five Times Sit to Stand Test (FTSST)
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.
Measured: pre-test, 4weeks and 8 weeks
Single-Leg Stance Test (SLST)
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.
Measured: pre-test, 4weeks and 8 weeks
Isometric Strength Assessment
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.
Measured: pre-test, 4weeks and 8 weeks
Sit and Reach Test (SRT)
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
Measured: pre-test, 4weeks and 8 weeks
Back Scratch Test
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.
Measured: pre-test, 4weeks and 8 weeks
Body Composition Analysis
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.
Measured: pre-test, 4weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Dec 2024
- Primary completion5 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Older adult participants attended an orientation at the SHPH, where a licensed physical therapist provided instruction on active static stretching and breathing techniques. Each participant received an illustrated manual and logbook. The 8-week hybrid program included home-based stretching with one supervised session weekly. Exercises targeted neck, trunk, upper and lower limb muscles (e.g., flexors, extensors, pectorals, triceps, hamstrings, adductors). Movements were done 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. Participants trained 5 days/week (4 home, 1 group). Community health volunteers provided weekly follow-up.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Phayao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chonticha Kaewjoho, University of Phayao
- Investigators
- Chonticha Kaewjoho, PT, PhD Kaewjoho, Principal investigator, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944886
- Sponsor's protocol ID
- UPhayaoChonticha-220
- Acronym
- stretching
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Stretching Exercises on Autonomic Cardiovascular Responses and Arterial Stiffness in Elderly Individuals With Low Flexibility Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06944886
- Acronym / sponsor ID
- stretching / UPhayaoChonticha-220
- Keywords
- Active static stretching, Arterial stiffness, Autonomic nervous system response, Lower-limb flexibility, Balance control in older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PhayaoUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of the effects of active static stretching exercise in elderly people with poor lower extremity muscle flexibility on autonomic and cardiovascular responses and balance ability.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Older adult participants attended an orientation at the SHPH, where a licensed physical therapist provided instruction on active static stretching and breathing techniques. Each participant received an illustrated manual and logbook. The 8-week hybrid program included home-based stretching with one supervised session weekly. Exercises targeted neck, trunk, upper and lower limb muscles (e.g., flexors, extensors, pectorals, triceps, hamstrings, adductors). Movements were done 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. Participants trained 5 days/week (4 home, 1 group). Community health volunteers provided weekly follow-up.
| Arm | Type | Receives |
|---|---|---|
| Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group) | Experimental | Other: 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. |
| Control group | No intervention | –regular activity |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)Also: Active Static StretchingParticipants 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 | Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group) |
Primary outcome
Heart Rate Variability (HRV) Assessment
Time frame: pre-test, 4weeks and 8 weeks
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.
Timed Up and Go (TUG) Test
Time frame: pre-test, 4weeks and 8 weeks
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.
Hand Grip Strength Test
Time frame: pre-test, 4weeks and 8 weeks
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.
Five Times Sit to Stand Test (FTSST)
Time frame: pre-test, 4weeks and 8 weeks
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.
Single-Leg Stance Test (SLST)
Time frame: pre-test, 4weeks and 8 weeks
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.
Isometric Strength Assessment
Time frame: pre-test, 4weeks and 8 weeks
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.
Sit and Reach Test (SRT)
Time frame: pre-test, 4weeks and 8 weeks
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
Back Scratch Test
Time frame: pre-test, 4weeks and 8 weeks
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.
Body Composition Analysis
Time frame: pre-test, 4weeks and 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chonticha Kaewjoho, PT, PhD Kaewjoho principal investigator
University of Phayao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group) in people with Arterial Stiffness and Autonomic Nervous System, run by University of Phayao at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) Assessment (time frame: pre-test, 4weeks and 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.