NCT06944886

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 10, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Active static stretchingArterial stiffnessAutonomic nervous system responseLower-limb flexibilityBalance control in older adults

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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

    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.

    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.

    pre-test, 4weeks and 8 weeks

Study Arms (2)

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.

Other: Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)

Control group

NO INTERVENTION

regular activity

Interventions

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."

Also known as: Active Static Stretching
Active Static Stretching Exercise Combined with Breathing Exercise (Experimental Group)

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonticha Kaewjoho

Phayao, 56000, Thailand

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Breathing ExercisesMuscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chonticha Kaewjoho, PT, PhD Kaewjoho

    University of Phayao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Physical Therapy

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 25, 2025

Study Start

December 1, 2024

Primary Completion

April 5, 2025

Study Completion

April 9, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations