Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05825989
Other study ID # IRB-NS2022/96.2811
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date August 31, 2024

Study information

Verified date April 2024
Source Kaohsiung Medical University
Contact Siriluk Sithichoksakulchai, Master's degree
Phone 0981136455
Email jib.siriluk@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the effects of the first three months of instructor-led HBA regimen on physical fitness (aerobic endurance, lung capacity, upper body flexibility, lower body flexibility, handgrip strength, upper body strength, and lower body strength) between the HBA intervention and control groups, to test the effects of another three months of DVD-led HBA regimen followed by the three months of instructor-led on physical fitness between the HBA intervention and control groups and to test the changes at three and six months of the HBA regimen in comparison to the baseline of the physical fitness in the HBA intervention group.


Description:

After the researcher meet the potential participants regarding the inclusion criteria, the researcher will inform purpose of study, human subjects protection, and termination in this study. Once participants receive all information and need to participate in this study, the researcher will ask permission participants to sign in their names in the informed consent and participant information sheet. If participants cannot sign their names, a thumbprint will be used instead of signatures. Therefore, the consent form will be completed by signatures or thumbprints. This study will conduct in group exercise. The intervention group will receive the HBA program, 40 min/time, 3 times/week for 6 months. The control group will continue their routine activities of the residential homes.


Recruitment information / eligibility

Status Recruiting
Enrollment 92
Est. completion date August 31, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Mild to moderate dependence or complete independence as defined by an Activity Daily Living assessment using the Barthel Index (BI Thai version) with a score of 61 or higher - No cognitive impairment defined by a Short Portable Mental Status Questionnaire (SPMSQ Thai version) a score of = 8 - No experience with the HBA regimen - Able to communicate in Thai Exclusion Criteria: - Older adults whom physicians have advised not to exercise because of medical conditions, severe disease, such as severe cardiopulmonary disease (CVD, COPD), or severe musculoskeletal diseases, and have sensory impairments such as visual and auditory impairments.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy Beat Acupunch Regimen
The Healthy Beat Acupunch (HBA) regimen, developed by Chen et al. (2017), is based on the Meridian Theory or Jing-Luo Theory. The HBA regimen focuses on body movement with hands swinging, resulting in the natural swinging of fists that hit on acupoints. There are three phases: phase 1 is activating qi and blood; phase 2 is punching meridians; phase 3 is relaxing body and mind.

Locations

Country Name City State
Thailand Ban Bang Khae Social Welfare Development Center for Older Persons Bang Khae Bangkok
Thailand Watsanawet Social Welfare Development Center for Older Persons Nakhon Luang Ayutthaya

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical fitness: aerobic endurance Aerobic endurance will be assessed by the 2 minutes step test. Participants will be asked to stand up in a straight position. The assessor marks the middle length between the patella and the pelvic bones at the wall with color tape. Participants raise their knees above the marked height as much as possible within 2 minutes. The score is the number of times the participants raise their knees above the marked height, which will be recorded. pretest (before receiving the HBA regimen)
Primary Physical fitness: aerobic endurance Aerobic endurance will be assessed by the 2 minutes step test. Participants will be asked to stand up in a straight position. The assessor marks the middle length between the patella and the pelvic bones at the wall with color tape. Participants raise their knees above the marked height as much as possible within 2 minutes. The score is the number of times the participants raise their knees above the marked height, which will be recorded. posttest 1 (after receiving the HBA regimen at 3 months)
Primary Physical fitness: aerobic endurance Aerobic endurance will be assessed by the 2 minutes step test. Participants will be asked to stand up in a straight position. The assessor marks the middle length between the patella and the pelvic bones at the wall with color tape. Participants raise their knees above the marked height as much as possible within 2 minutes. The score is the number of times the participants raise their knees above the marked height, which will be recorded. posttest 2 (after receiving the HBA regimen at 6 months)
Primary Physical fitness: lung capacity Lung capacity will be assessed by a TruZoneTM Peak Flow Meter. The TruZone will be reset to zero before participants hold the mouth-piece in their mouth. The score is the measurement of a deep breath, which is exhaled forcefully quickly in one out-breath. This will be recorded in liters. pretest (before receiving the HBA regimen)
Primary Physical fitness: lung capacity Lung capacity will be assessed by a TruZoneTM Peak Flow Meter. The TruZone will be reset to zero before participants hold the mouth-piece in their mouth. The score is the measurement of a deep breath, which is exhaled forcefully quickly in one out-breath. This will be recorded in liters. posttest 1 (after receiving the HBA regimen at 3 months)
Primary Physical fitness: lung capacity Lung capacity will be assessed by a TruZoneTM Peak Flow Meter. The TruZone will be reset to zero before participants hold the mouth-piece in their mouth. The score is the measurement of a deep breath, which is exhaled forcefully quickly in one out-breath. This will be recorded in liters. posttest 2 (after receiving the HBA regimen at 6 months)
Primary Physical fitness: upper body flexibility Upper body flexibility will be evaluated by a back scratch test. Participants raise their favored hand above the same shoulder and put their palm face down on their back with the fingers in a downward direction as much as possible. The other hand is placed palm up on the middle of the back as high as possible. The score is the distance in centimeters between the tips of the middle fingers, which will be recorded. If the tips of the middle fingers cannot touch, participants receive a minus score, if the middle fingers just touch a zero score is recorded, and if the tips of the middle fingers can overlap, participants receive a plus score. pretest (before receiving the HBA regimen)
Primary Physical fitness: upper body flexibility Upper body flexibility will be evaluated by a back scratch test. Participants raise their favored hand above the same shoulder and put their palm face down on their back with the fingers in a downward direction as much as possible. The other hand is placed palm up on the middle of the back as high as possible. The score is the distance in centimeters between the tips of the middle fingers, which will be recorded. If the tips of the middle fingers cannot touch, participants receive a minus score, if the middle fingers just touch a zero score is recorded, and if the tips of the middle fingers can overlap, participants receive a plus score. posttest 1 (after receiving the HBA regimen at 3 months)
Primary Physical fitness: upper body flexibility Upper body flexibility will be evaluated by a back scratch test. Participants raise their favored hand above the same shoulder and put their palm face down on their back with the fingers in a downward direction as much as possible. The other hand is placed palm up on the middle of the back as high as possible. The score is the distance in centimeters between the tips of the middle fingers, which will be recorded. If the tips of the middle fingers cannot touch, participants receive a minus score, if the middle fingers just touch a zero score is recorded, and if the tips of the middle fingers can overlap, participants receive a plus score. posttest 2 (after receiving the HBA regimen at 6 months)
Primary Physical fitness: lower body flexibility Lower body flexibility will be assessed by the chair sit-and-reach test. Participants sit on the front of a chair, then fully extend their right leg and place their foot up 90 degrees. Then, they move both hands to touch the big toe. The score is the distance in centimeters between the middle fingers of both hands and the big toe of the right foot, which will be recorded. Suppose their middle fingers cannot reach the big toe of the right foot. In that case, participants receive a minus score, if their middle fingers can reach the top of their big toe, a zero score is recorded, and if their middle fingers can reach or pass their big toe, participants receive a plus score. pretest (before receiving the HBA regimen)
Primary Physical fitness: lower body flexibility Lower body flexibility will be assessed by the chair sit-and-reach test. Participants sit on the front of a chair, then fully extend their right leg and place their foot up 90 degrees. Then, they move both hands to touch the big toe. The score is the distance in centimeters between the middle fingers of both hands and the big toe of the right foot, which will be recorded. Suppose their middle fingers cannot reach the big toe of the right foot. In that case, participants receive a minus score, if their middle fingers can reach the top of their big toe, a zero score is recorded, and if their middle fingers can reach or pass their big toe, participants receive a plus score. posttest 1 (after receiving the HBA regimen at 3 months)
Primary Physical fitness: lower body flexibility Lower body flexibility will be assessed by the chair sit-and-reach test. Participants sit on the front of a chair, then fully extend their right leg and place their foot up 90 degrees. Then, they move both hands to touch the big toe. The score is the distance in centimeters between the middle fingers of both hands and the big toe of the right foot, which will be recorded. Suppose their middle fingers cannot reach the big toe of the right foot. In that case, participants receive a minus score, if their middle fingers can reach the top of their big toe, a zero score is recorded, and if their middle fingers can reach or pass their big toe, participants receive a plus score. posttest 2 (after receiving the HBA regimen at 6 months)
Primary Physical fitness: handgrip strength Handgrip strength will be assessed by using a digital handgrip dynamometer. Participants hold the dynamometer with the fingers of their dominant hand and keep their arm parallel to the side of their body without moving the arm, then squeeze the holder for 3 seconds as hard as possible. Participants' handgrip strength will be measured two times. The score of the highest value will be recorded. pretest (before receiving the HBA regimen)
Primary Physical fitness: handgrip strength Handgrip strength will be assessed by using a digital handgrip dynamometer. Participants hold the dynamometer with the fingers of their dominant hand and keep their arm parallel to the side of their body without moving the arm, then squeeze the holder for 3 seconds as hard as possible. Participants' handgrip strength will be measured two times. The score of the highest value will be recorded. posttest 1 (after receiving the HBA regimen at 3 months)
Primary Physical fitness: handgrip strength Handgrip strength will be assessed by using a digital handgrip dynamometer. Participants hold the dynamometer with the fingers of their dominant hand and keep their arm parallel to the side of their body without moving the arm, then squeeze the holder for 3 seconds as hard as possible. Participants' handgrip strength will be measured two times. The score of the highest value will be recorded. posttest 2 (after receiving the HBA regimen at 6 months)
Primary Physical fitness: upper body strength Upper body strength will be assessed by a 60-second arm curl test. Participants sit on a chair and hold a dumbbell with their dominant hand (8-pound or 3.63 kilograms for men and 5-pound or 2.27 kilograms for women). Then, they lift the dumbbell up and down using the forearm repetitively. The score is the number of repetitions within 60 seconds, which will be recorded. pretest (before receiving the HBA regimen)
Primary Physical fitness: upper body strength Upper body strength will be assessed by a 60-second arm curl test. Participants sit on a chair and hold a dumbbell with their dominant hand (8-pound or 3.63 kilograms for men and 5-pound or 2.27 kilograms for women). Then, they lift the dumbbell up and down using the forearm repetitively. The score is the number of repetitions within 60 seconds, which will be recorded. posttest 1 (after receiving the HBA regimen at 3 months)
Primary Physical fitness: upper body strength Upper body strength will be assessed by a 60-second arm curl test. Participants sit on a chair and hold a dumbbell with their dominant hand (8-pound or 3.63 kilograms for men and 5-pound or 2.27 kilograms for women). Then, they lift the dumbbell up and down using the forearm repetitively. The score is the number of repetitions within 60 seconds, which will be recorded. posttest 2 (after receiving the HBA regimen at 6 months)
Primary Physical fitness: lower body strength Lower body strength will be assessed by the 60 seconds chair sit-to-stand test. Participants sit on the middle of the chair without an armrest or wheels. They put their feet on the floor equal width to their shoulder width. Then, they place both hands on their opposite shoulders. The score is the number of times that the subjects can stand up and sit down within 60 seconds, which will be recorded. pretest (before receiving the HBA regimen)
Primary Physical fitness: lower body strength Lower body strength will be assessed by the 60 seconds chair sit-to-stand test. Participants sit on the middle of the chair without an armrest or wheels. They put their feet on the floor equal width to their shoulder width. Then, they place both hands on their opposite shoulders. The score is the number of times that the subjects can stand up and sit down within 60 seconds, which will be recorded. posttest 1 (after receiving the HBA regimen at 3 months)
Primary Physical fitness: lower body strength Lower body strength will be assessed by the 60 seconds chair sit-to-stand test. Participants sit on the middle of the chair without an armrest or wheels. They put their feet on the floor equal width to their shoulder width. Then, they place both hands on their opposite shoulders. The score is the number of times that the subjects can stand up and sit down within 60 seconds, which will be recorded. posttest 2 (after receiving the HBA regimen at 6 months)
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A