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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06466408
Other study ID # NCKU HREC-E-112-419-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 25, 2024
Est. completion date July 30, 2024

Study information

Verified date June 2024
Source Tainan University of Technology
Contact SHU-CHENG LIN, PhD
Phone +886912997187
Email s0975835@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study explores the effectiveness of fruit and vegetable enzyme supplementation in reducing fatigue and enhancing aerobic capacity in elderly individuals after engaging in high-intensity interval exercise (HIIE) through exergaming. Sixteen elderly female participants were divided into two groups based on pre-test lactate levels: an enzyme group and a placebo group, to ensure comparability. They performed HIIE using Nintendo Switch Ring Fit Adventure, completing eight sets of 20-second high-effort exercises with 30-second rest intervals, totaling 370 seconds of activity. The primary metrics evaluated were blood lactate levels, heart rate (HR), rating of perceived exertion (RPE), and training impulse (TRIMP). Participants in the enzyme group received a fruit and vegetable enzyme supplement in a 30 c.c. dose twice daily for 14 days. The study aimed to determine if enzyme supplementation could effectively mitigate the physiological stress of HIIE and improve exercise outcomes in the elderly.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Aged 65 and above 2. healthy elderly participants 3. regular exercise habit (3 times per week within the past year) 4. Those who can move their upper and lower limbs normally Exclusion Criteria: 1. no history of upper limb skeletal muscle injury or major injury 2. No heart-related diseases such as high blood pressure 3. No related chronic diseases, such as diabetes

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Supplementation Protocol
After the pre-test, the enzyme group consumed 30 mL of vegetable and fruit enzymes (The contents include needle-leaf cherries, cherries, apples, cranberries, blackberries, black currants, blueberries, beets, broccoli, cabbage, carrots, Concord grapes, cranberries, elderberries, kale, oranges, peaches, papayas, parsley, pineapples, raspberries, red currants, spinach, and tomatoes, etc.)(Enzyme Village, Chiayi, Taiwan) mixed with 150 mL of water twice a day (at breakfast and dinner) for 14 consecutive days. The placebo group followed the same protocol but consumed malt syrup (Amazon, USA) instead until the end of the study. Participants returned to the laboratory each morning to receive the daily supplement, which was administered on-site. Following supplementation, participants reported their dinner intake to the researchers, ensuring compliance with the prescribed supplementation regimen.
Diagnostic Test:
Blood Lactate Test
The blood lactate was measured at five time points: before exercise, after the fourth and eighth bouts of exercise, and at 5 and 10 minutes after exercise. The blood lactate were analyzed using a Biosen Cline blood analysis system (EKF-diagnostic, Germany). Capillary blood samples of 10 µL were collected and added to red blood cell lysis reagent and stored at low temperature until analyzed. Prior to analysis, instrument standardization and test calibration were performed, and the coefficient of variation was determined to be =1.5%. The detection range for blood lactate was 0.5-40 mM
Training Impulse
In this study, the exercise load was represented by the TRIMP [32], which is calculated as the product of exercise intensity and duration. To accommodate the convenience of the experiment, two different TRIMP calculation methods were used, including % HRmax (objective) and RPE (subjective). At the end of each exercise bout (8 bouts in total) and during the recovery period before the next bout (7 bouts in total), participants were asked to report their RPE, and their heart rate was recorded. This process was repeated 8 times.
Exergaming HIIE Test
The sensor system utilized two Nintendo controllers: one mounted on the exercise ring and the other secured to the participant's thigh to enhance gameplay interaction. Through the Ring-Con, participants engaged in diverse physical activities such as weightlifting, yoga, and aerobic exercises. The fitness ring sensor accurately captures and integrates players' movements into the game. The gameplay involves unlocking levels and engaging in fitness challenges that are achieved through actual physical activities. It offers a wide range of exercise routines targeting various muscle groups and provides engaging gaming challenges. The exercise protocol included eight sets of 20-second high-effort exercises, interspersed with 30-second rest intervals, totaling 370 seconds of active exercise time. Specifically, the fitness game mode used was the Adventure Mode in 'Ring Fit Adventure,' comprising exercises targeting the pectoralis major, latissimus dorsi, deltoids, and quadriceps muscles.

Locations

Country Name City State
Taiwan Tainan University of Technology Tainan City

Sponsors (1)

Lead Sponsor Collaborator
Shu-Cheng Lin

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lactate Measure lactate level with fingertip blood test in Exergaming HIIE pre and after-intervention: measurements taken before the test, during the 2 and 4 minute of the test, and 5 and 10 minutes after the test.
Primary Heart rate (bpm) Use a heart rate monitor to record heart rate in Exergaming HIIE Collect the heart rate at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Primary Borg 0-10 score rating of perceived exertion (RPE) Use Borg 0-10 score RPE to record RPE in Exergaming HIIE Collect the RPE at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Secondary Training Impulse Calculate the subjective and objective training Impulse (arbitrary unit, AU) based on the heart rate and RPE. During Exergaming HIIE
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