AgingNCT04940884
Supervised Exercise Training Effects on Older Community Dwellers
A study testing Supervised exercise training and Aerobic exercise training in people with Aging, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Altered circulating microRNA (miRNA) after physical activity reflects exercise effects on muscle performance and cardiorespiratory fitness. The present work was designed to highlight associations between exercise-induced physical fitness miRNAs in community-indwelling elderly adults. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Supervised exercise training and Aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 31 Jan 2022
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary
- 1.Community-indwelling individuals with age>=55 years, who lived adjacent to a community hospital were surveyed.
- Secondary
- Adults with mini-mental state examination (MMSE) score > 24
- Negative lumbar spine as well as lower extremity degenerative joint disorder were recruited.
Who cannot join
- unstable angina
- unstable BP
- severe aortic stenosis
- inflammatory disease within recent 3 months
- uncontrolled or severe cardiac dysrhythmias
- uncompensated HF
Show all 11Show fewer
- embolic disease within recent 3 months
- ST segment displacement>=2 mm at rest
- uncontrolled diabetes
- sarcopenia
- Patients with absolute contraindications of exercise training (Pescatello LS, Arena R, Riebe D and Thompson PD. ACSM's guidelines for exercise testing and prescription. 9th ed. Philadelphia, PA.: Wolters Kluwer/Lippincott Williams \& Wilkins; 2014.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise Intervention on Health-related Physical Fitness and Circulating microRNA in the Community Senior Residents
Altered circulating microRNA (miRNA) after physical activity reflects exercise effects on muscle performance and cardiorespiratory fitness. The present work was designed to highlight associations between exercise-induced physical fitness miRNAs in community-indwelling elderly adults. Baseline clinical information was assessed for community-indwelling individuals, long-term followed by our community medicine research center, aged >=55 years near our hospital. Among them, participants were randomly assigned to the supervised exercise training (SET) and home exercise training (HET) groups. All included subjects were instructed to walk>=8000 steps per day (stp/d), which was recorded by wrist-worm smart watches. SET Participants underwent 24 sessions of moderate-intensity exercise training (MICT) at 70% maximum predicted heart rate for 30 min in each session. HET participants underwent walking activities as the above instruction. Movement analysis and body composition measurements were used to assess physical fitness at baseline and 8 as well as 24 weeks after recruitment. MiRNAs (miR-21, miR-126, miR-146a, and miR-222) were also examined at the above time point. SET participants took significantly more steps per day and had greater chance to walk>=8000 stp/d in the community compared to the SET participants during follow-up. Prominent beneficial effects on physical fitness, including cardiorespiratory fitness, flexibility, lower extremity muscle strength, and body composition, were noticed during and 16 weeks after stopping SET. Increased miR146a and miR-126 expressions reflecting increased anti-inflammatory response and enhanced angiogenesis, respectively after 8 weeks of SET. However, inhibited skeletal as well as cardiac muscle catabolism respectively reflecting in the increased miR-21 and miR-222 were also identified in the present work. These observations may clarify short-term SET effects on lifestyle in community inhabitants and how sensitive of miRNAs to exercise-induced physiological adaptations.
Read the detailed description
Design The Institutional Review Board of a tertiary care hospital approved the study (IRB No.: 201602058A3C502 and NCT04839796). A randomized controlled trial with assessor and subject blinded study for effects of exercise regimens on ageing persons was performed from May to November 2021. All subjects provided informed consent after understanding the experimental procedures. Participants were then randomly allocated to undergo 30 min of supervised exercise training (SET) at moderate-intensity continuous training (MICT) for 24 sessions in the hospital or home exercise training (HET) groups using a computer-generated, concealed allocation schedule. Data were collected by a blinded assessor prior to randomization and after completing the exercise training.
Participants Community-indwelling individuals with age>=55 years, who lived adjacent to a community hospital were surveyed. Elderly adults with mini-mental state examination (MMSE) score > 24 and negative lumbar spine as well as lower extremity degenerative joint disorder were recruited. Those who had unstable clinical presentations mentioned in our previous studies, or sarcopenia, diagnosed based on the recommendation of the Asian Working Group for Sarcopenia, were not candidates of the study. We also excluded individuals with absolute contraindications for aerobic activities, suggested by the American College of Sports Medicine (ACSM). The baseline physical component score (PCS) and mental component scores (MCS) in the Medical Outcomes Study Short Form 36 (SF-36) were used to assess the quality of life (QoL) and were re-evaluated 24 weeks after the recruitment. Baseline demographic characteristics and clinical information of included participants were carefully recorded.
Exercise Training All subjects were instructed to wear a smart watch (WDI08, WisDat Inc., Taichung, Taiwan) and to take at least 8000 steps per day (stp/d). In addition to 8000 stp/d, the SET participants underwent 24 sessions of supervised MICT (70% of maximum predicted HR) for 30-min on a bicycle ergometer (Ergoselect 150P, ergoline GmbH, Bitz, Germany) in our hospital during an 8-week period. All subjects were reminded to take >=8000 stp/d every week during the first 8-week after recruitment by phone call and app. After completing the MICT, SET participants were instructed to take >=8000 stp/d for another 16 weeks. HET participants were instructed to take 8000 stp/d over the 24-week follow-up period. During the latter 16-week, the instruction of taking>=8000 stp/d was not reminded in all subjects. The exercise training was terminated when the subject had symptoms/signs during exercise according to the ACSM guideline.20 Measurement of physical fitness The wrist-worn smart watch (WDI08, Wisdat Inc., Taichung, Taiwan) recorded the every-day step count and energy expenditure in each subject, and the average number of steps and energy expenditure (Kcal) per day in a week represented the mean every day steps and energy expenditure of a week in community during the 24-week follow-up period.
The calf circumference (Calf_circ) was obtained by averaging the greatest Calf_circ in bilateral legs. Intelligent movement analysis (eFitHealth, uCare Medical Electronics, Co. Ltd., Miaoli, Taiwan) using interactive voices and 3D depth image guides to assess 2-min step number, 5-time sit-to-stand duration, and chair sit-and-reach distance (Supplementary Data 1). Each of the above test was used to estimate VO2max (eV O2max), lower extremity muscle strength, and flexibility, respectively.21 Body composition, including total body water (TBW), mineral portion, protein amount (Prot), lean body mass (LBM), skeletal muscle mass (SKM), body fat mass (BFM), and basal metabolic rate (BMR) were measured by multiple frequency bioimpedance analysis (Inbody 720, Inbody Co., Ltd., CA, USA). The above measurements were documented before, 8-week after, and 24-week after initial visit.
RNA extraction Blood sampling of 10 ml whole blood from each subject at the recruitment, 8-week, and 24-week from the initial visit was placed in a tube containing 3.2% sodium citrate. Samples were then centrifuged at 360xg for 15 min, which supernatant was further centrifuged at 2400xg for 20 min at room temperature of 25 ℃ to keep plasma platelet count less than 2.5×10^8/ml. Processed plasma of 400 microL was placed in a 2mL eppendorf (Eppendorf corp. Hamburg, Germany) to mix with 1200 microL TRIzol (ThermoFisher Scientific Inc., Waltham, MA, USA) and 5 microL miR-39 (5x10^-15 mol/microL), exogenous control, of C. elegans as well as 2 microg (10 microg/mL in plasma) yeast RNA (Invitrogen, Carlsbad, CA, USA) for 15 min at room temperature. Another 320 microL chloroform was added and placed at room temperature for 5 min. The specimen was centrifuged at 12000 xg for 15 min at 4 ℃ and 300 microL colorless fluid layer was aspirated to mix with 900 microL iced 100% ethanol overnight at -80 ℃. The prepared specimen was placed into the Direct-zol column (Direct-zol RNA Miniprep, Zymo Research corp., Irvine, CA, USA) and was then centrifuged at 12000 xg for 30 sec. The column was then transferred to a new collection tube and was centrifuged at 12000 xg for 30 sec after mixing with 400 microL RNA wash buffer. DNase I reaction mix of 80 microL (DNase I enzyme 5 microL+DNA digestion buffer 75 microL) was added to the tube after discarding the RNA wash buffer and was incubated at room temperature for 15 min. Additional 400 microL pre-wash buffer was introduced into the tube and was centrifuged at 12000 xg for 30 sec. The column was then transferred into a new 1.5 mL RNase-free tube and was treated with 80 microL nuclease-free water at room temperature for 2min. The prepared sample was centrifuged at 12000 xg for 2 min to elute RNA solution.
Quantification of plasma microRNA levels miR-21, miR-126, miR-146a and miR-222 levels at the above three different time was analyzed. One-step real-time quantitative polymerase chain reaction (RT-qPCR) was performed using a RT-qPCR system (T100TM Thermal Cycler, Bio-Rad Laboratories Inc., Berkeley, CA, USA) to assess plasma microRNA levels. A mixture of 100 ng total RNA extraction, 10 microL TaqMan master mix (ThermoFisher), 5.8 microL nuclease-free water, 0.2 microL universal probe library 21 (10 microM), 0.1 microL RNase inhibitor, self-constructed 1 microL forward primers and 1 microL reverse primers for miR-39, miR-126 and miR-146a, and 2 microL cDNA template were created on ice. All reactions were incubated in a 48-well plate at 95°C for 3 min, followed by 40 cycles of 95°C for 5 sec, 60°C for 10 sec and 72°C for 1 sec. Self-constructed forward and reverse primer sequences for primary C. elegans miR-39 (C-miR-39) as exogenous control. Human miR-126 (miR-126) and miR-146a (miR-146a) (Supplementary Table 1) were normalized by the exogenous control and were used to determine the microRNA levels expressions during the follow-up.
miRCURY LNA SYBR Green PCR kit (Qiagen) was used to determine human miR-21 (miR-21) and miR-222 (miR-222). A mixture of 4 microL 5X miRCURY RT SYBR Green Reaction Buffer, 2 microL 10X miRCURY RT Wnzyme Mix and 14 microL of 100 ng total RNA extraction in nuclease-free water was incubated in a 48-well plate at 42°C for 60 min and followed by 95°C to generate cDNA. A mixture containing 2 microL C-miR-39 (or miR-21/ or miR-222) primers purchased from Qiagen, 10 microL miRCURY SYBR Green Master Mix, 2 microL nuclease-free water and 6 microL 5X generated cDNA template was incubated at 95°C for 2 min, followed by 40 cycles of 95°C for 10 sec and 56°C for 60 sec. has-miR-21 and hsa-miR-222 were normalized by the C-miR-39 and were used to determine the microRNA levels expressions during the follow-up.
Determination of inflammatory activity 300 microL of serum was diluted by 1:2 ratios. Loaded 50 microL of prepared samples per well and calibrators in duplicate onto the assay plate (Multiplex Human Cytokine Panel 1, Boster Biological Technology, Pleasanton, CA, USA). Each well containing antibodies captured IL-1α, IL-1β, IL-6, IL-10, and TNFα. A mixture that contains biotinylated analyte specific antibodies is added after washing away any unbound protein. The biotinylated antibodies completed the sandwich for each specific arrayed analyte. After washing away unbound biotinylated antibody, streptavidin horseradish peroxidase (SHRP) is added. Following an additional wash, the amount of SHRP remaining on each location of the array is proportional to the amount of the above initially captured cytokines. The amount of conjugated enzyme on each location of the array is measured with the addition of a chemiluminescent substrate.
Statistical analysis Data are presented as mean (95% CI) or n (%). Differences of continuous and nominal parameters and between the two groups were estimated by student-t and chi-square tests, respectively. Repeated measurement ANOVA was conducted to analyze differences of continuous parameters measured at the three time points in each group. Pearson correlation was performed to find the relationship between physical fitness and miRNAs. A p value less than 0.05 was considered as statistical significance.
- Conditions
- Aging
- Being tested
- Supervised exercise training, Aerobic exercise training
- Keywords
- aerobic exercise, physical fitness, body compositions, micro rna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise trainingBehavioural
SET Participants underwent 24 sessions of moderate-intensity exercise training (MICT) at 70% maximum predicted heart rate for 30 min in each session
Aerobic exercise trainingBehavioural
All recruited subjects were instructed to walk >=8000 steps per day in the community. Part of the participants were randomly assigned to underwent additional 24 sessions of supervised aerobic exercise training (SET) with the intensity at 70% of maximum predicted heart rate and the remaining participants follow the above home exercise training (HET) instruction without additional supervised exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise training | Experimental | Pre- and Post- exercise training effects. Part of the participants were randomly assigned to underwent additional 24 sessions of supervised exercise training (SET) and the remaining participants follow the above instruction without additional supervised exercise training. After the 24 sessions of SET, they were then followed a 16-week of follow-up of their daily activities without additional exercise training. Receives: Behavioral: Supervised exercise training; Behavioral: Aerobic exercise training |
| home exercise training | Active comparator | All included subjects were instructed to walk>=8000 steps per day (stp/d), which was recorded by wrist-worm smart watches Receives: Behavioral: Aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking steps per day (stp/d)
mean every day walking steps in a week measured by a wrist-worn smart watch
Measured: 24 weeks
energy expenditure per day (Kcal/d)
mean every day energy consumption in a week estimated by a wrist-worn smart watch.
Measured: 24 weeks
estimated maximum oxygen consumption (eVO2max)
maximum energy consumption estimated from 2-min step numbers measured by an interactive voices and 3D depth imaging device.
Measured: Initial recruitment
estimated maximum oxygen consumption (eVO2max)
maximum energy consumption estimated from 2-min step numbers measured by an interactive voices and 3D depth imaging device.
Measured: 8 weeks after recruitment
estimated maximum oxygen consumption (eVO2max)
maximum energy consumption estimated from 2-min step numbers measured by an interactive voices and 3D depth imaging device.
Measured: 24 weeks after recruitment
Calf circumference (cm)
Average maximum calf circumference of bilateral legs obtained by measuring tape.
Measured: Initial recruitment
Calf circumference (cm)
Average maximum calf circumference of bilateral legs obtained by measuring tape.
Measured: 8 weeks after recruitment
Calf circumference (cm)
Average maximum calf circumference of bilateral legs obtained by measuring tape.
Measured: 24 weeks after recruitment
5-time sit-to-stand duration (second)
5-time sit-to-stand duration measured by an interactive voices and 3D depth imaging device.
Measured: Initial recruitment
5-time sit-to-stand duration (second)
5-time sit-to-stand duration measured by an interactive voices and 3D depth imaging device.
Measured: 8 weeks after recruitment
5-time sit-to-stand duration (second)
5-time sit-to-stand duration measured by an interactive voices and 3D depth imaging device.
Measured: 24 weeks after recruitment
Sit-and-reach distance (cm)
Hand reaching distance while performing forward bending in a sitting position
Measured: Initial recruitment
Sit-and-reach distance (cm)
Hand reaching distance while performing forward bending in a sitting position
Measured: 8 weeks after recruitment
Sit-and-reach distance (cm)
Hand reaching distance while performing forward bending in a sitting position
Measured: 24 weeks after recruitment
Normalized total body water content (%)
Total body water content obtained from bioimpedance measurement and was then normalized by body weight
Measured: Initial recruitment
Normalized total body water content (%)
Total body water content obtained from bioimpedance measurement and was then normalized by body weight
Measured: 8 weeks after recruitment
Normalized total body water content (%)
Total body water content obtained from bioimpedance measurement and was then normalized by body weight
Measured: 24 weeks after recruitment
Normalized total mineral content (%)
Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.
Measured: Initial recruitment
Normalized total mineral content (%)
Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.
Measured: 8 weeks after recruitment
Normalized total mineral content (%)
Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.
Measured: 24 weeks after recruitment
Normalized total protein amount (%)
Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.
Measured: Initial recruitment
Normalized total protein amount (%)
Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.
Measured: 8 weeks after recruitment
Normalized total protein amount (%)
Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.
Measured: 24 weeks after recruitment
Normalized body fat mass (%)
Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.
Measured: Initial recruitment
Normalized body fat mass (%)
Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.
Measured: 8 weeks after recruitment
Normalized body fat mass (%)
Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.
Measured: 24 weeks after recruitment
Normalized skeletal mass to lean body mass percentage (%)
Total skeletal mass obtained from bioimpedance measurement and was then normalized by lean body mass.
Measured: Initial recruitment
Normalized skeletal mass to lean body mass percentage (%)
Total skeletal mass obtained from bioimpedance measurement and was then normalized by lean body mass.
Measured: 8 weeks after recruitment
Normalized skeletal mass to lean body mass percentage (%)
Total skeletal mass obtained from bioimpedance measurement and was then normalized by lean body mass.
Measured: 24 weeks after recruitment
miR-21 (relative intensity)
Ratio of human micro RNA 21 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: Initial recruitment
miR-21 (relative intensity)
Ratio of human micro RNA 21 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 8 weeks after recruitment
miR-21 (relative intensity)
Ratio of human micro RNA 21 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 24 weeks after recruitment
miR-126 (relative intensity)
Ratio of human micro RNA 126 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: Initial recruitment
miR-126 (relative intensity)
Ratio of human micro RNA 126 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 8 weeks after recruitment
miR-126 (relative intensity)
Ratio of human micro RNA 126 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 24 weeks after recruitment
miR-146a (relative intensity)
Ratio of human micro RNA 146a measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: Initial recruitment
miR-146a (relative intensity)
Ratio of human micro RNA 146a measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 8 weeks after recruitment
miR-146a (relative intensity)
Ratio of human micro RNA 146a measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 24 weeks after recruitment
miR-222 (relative intensity)
Ratio of human micro RNA 222 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: Initial recruitment
miR-222 (relative intensity)
Ratio of human micro RNA 222 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 8 weeks after recruitment
miR-222 (relative intensity)
Ratio of human micro RNA 222 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
Measured: 24 weeks after recruitment
IL-1a (relative intensity)
Ratio of IL-1a obtained from ELISA assay plate at each time point to the baseline level.
Measured: Initial recruitment
IL-1a (relative intensity)
Ratio of IL-1a obtained from ELISA assay plate at each time point to the baseline level.
Measured: 8 weeks after recruitment
IL-1a (relative intensity)
Ratio of IL-1a obtained from ELISA assay plate at each time point to the baseline level.
Measured: 24 weeks after recruitment
IL-1b (relative intensity)
Ratio of IL-1b obtained from ELISA assay plate at each time point to the baseline level.
Measured: Initial recruitment
IL-1b (relative intensity)
Ratio of IL-1b obtained from ELISA assay plate at each time point to the baseline level.
Measured: 8 weeks after recruitment
IL-1b (relative intensity)
Ratio of IL-1b obtained from ELISA assay plate at each time point to the baseline level.
Measured: 24 weeks after recruitment
IL-6 (relative intensity)
Ratio of IL-6 obtained from ELISA assay plate at each time point to the baseline level.
Measured: Initial recruitment
IL-6 (relative intensity)
Ratio of IL-6 obtained from ELISA assay plate at each time point to the baseline level.
Measured: 8 weeks after recruitment
IL-6 (relative intensity)
Ratio of IL-6 obtained from ELISA assay plate at each time point to the baseline level.
Measured: 24 weeks after recruitment
IL-10 (relative intensity)
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
Measured: Initial recruitment
IL-10 (relative intensity)
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
Measured: 8 weeks after recruitment
IL-10 (relative intensity)
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
Measured: 24 weeks after recruitment
TNFa (relative intensity)
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
Measured: Initial recruitment
TNFa (relative intensity)
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
Measured: 8 weeks after recruitment
TNFa (relative intensity)
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
Measured: 24 weeks after recruitment
Physical component score (PCS)
Physical role function obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Initial recruitment
Physical component score (PCS)
Physical role function obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 24 weeks after recruitment
Mental component score (MCS)
Mental health score obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Initial recruitment
Mental component score (MCS)
Mental health score obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 24 weeks after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Chin Hsu, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940884
- Sponsor's protocol ID
- 201602058A3C502
- Status last verified
- Jul 2022
- First submitted
- 14 Jun 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang LY, Lim AY, Hsu CC, Tsai YF, Fu TC, Shyu YC, Peng SC, Wang JS. Sustainability of exercise-induced benefits on circulating MicroRNAs and physical fitness in community-dwelling older adults: a randomized controlled trial with follow up. BMC Geriatr. 2024 May 30;24(1):473. doi: 10.1186/s12877-024-05084-0.
PubMed 38816804
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Intervention on Health-related Physical Fitness and Circulating microRNA in the Community Senior Residents
- ClinicalTrials.gov ID
- NCT04940884
- Acronym / sponsor ID
- 201602058A3C502
- Conditions
- Aging
- Keywords
- aerobic exercise, physical fitness, body compositions, micro rna
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 28 Jun 2021 (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.
Altered circulating microRNA (miRNA) after physical activity reflects exercise effects on muscle performance and cardiorespiratory fitness. The present work was designed to highlight associations between exercise-induced physical fitness miRNAs in community-indwelling elderly adults. Baseline clinical information was assessed for community-indwelling individuals, long-term followed by our community medicine research center, aged >=55 years near our hospital. Among them, participants were randomly assigned to the supervised exercise training (SET) and home exercise training (HET) groups. All included subjects were instructed to walk>=8000 steps per day (stp/d), which was recorded by wrist-worm smart watches. SET Participants underwent 24 sessions of moderate-intensity exercise training (MICT) at 70% maximum predicted heart rate for 30 min in each session. HET participants underwent walking activities as the above instruction. Movement analysis and body composition measurements were used to assess physical fitness at baseline and 8 as well as 24 weeks after recruitment. MiRNAs (miR-21, miR-126, miR-146a, and miR-222) were also examined at the above time point. SET participants took significantly more steps per day and had greater chance to walk>=8000 stp/d in the community compared to the SET participants during follow-up. Prominent beneficial effects on physical fitness, including cardiorespiratory fitness, flexibility, lower extremity muscle strength, and body composition, were noticed during and 16 weeks after stopping SET. Increased miR146a and miR-126 expressions reflecting increased anti-inflammatory response and enhanced angiogenesis, respectively after 8 weeks of SET. However, inhibited skeletal as well as cardiac muscle catabolism respectively reflecting in the increased miR-21 and miR-222 were also identified in the present work. These observations may clarify short-term SET effects on lifestyle in community inhabitants and how sensitive of miRNAs to exercise-induced physiological adaptations.
Detailed description
Design The Institutional Review Board of a tertiary care hospital approved the study (IRB No.: 201602058A3C502 and NCT04839796). A randomized controlled trial with assessor and subject blinded study for effects of exercise regimens on ageing persons was performed from May to November 2021. All subjects provided informed consent after understanding the experimental procedures. Participants were then randomly allocated to undergo 30 min of supervised exercise training (SET) at moderate-intensity continuous training (MICT) for 24 sessions in the hospital or home exercise training (HET) groups using a computer-generated, concealed allocation schedule. Data were collected by a blinded assessor prior to randomization and after completing the exercise training.
Participants Community-indwelling individuals with age>=55 years, who lived adjacent to a community hospital were surveyed. Elderly adults with mini-mental state examination (MMSE) score > 24 and negative lumbar spine as well as lower extremity degenerative joint disorder were recruited. Those who had unstable clinical presentations mentioned in our previous studies, or sarcopenia, diagnosed based on the recommendation of the Asian Working Group for Sarcopenia, were not candidates of the study. We also excluded individuals with absolute contraindications for aerobic activities, suggested by the American College of Sports Medicine (ACSM). The baseline physical component score (PCS) and mental component scores (MCS) in the Medical Outcomes Study Short Form 36 (SF-36) were used to assess the quality of life (QoL) and were re-evaluated 24 weeks after the recruitment. Baseline demographic characteristics and clinical information of included participants were carefully recorded.
Exercise Training All subjects were instructed to wear a smart watch (WDI08, WisDat Inc., Taichung, Taiwan) and to take at least 8000 steps per day (stp/d). In addition to 8000 stp/d, the SET participants underwent 24 sessions of supervised MICT (70% of maximum predicted HR) for 30-min on a bicycle ergometer (Ergoselect 150P, ergoline GmbH, Bitz, Germany) in our hospital during an 8-week period. All subjects were reminded to take >=8000 stp/d every week during the first 8-week after recruitment by phone call and app. After completing the MICT, SET participants were instructed to take >=8000 stp/d for another 16 weeks. HET participants were instructed to take 8000 stp/d over the 24-week follow-up period. During the latter 16-week, the instruction of taking>=8000 stp/d was not reminded in all subjects. The exercise training was terminated when the subject had symptoms/signs during exercise according to the ACSM guideline.20 Measurement of physical fitness The wrist-worn smart watch (WDI08, Wisdat Inc., Taichung, Taiwan) recorded the every-day step count and energy expenditure in each subject, and the average number of steps and energy expenditure (Kcal) per day in a week represented the mean every day steps and energy expenditure of a week in community during the 24-week follow-up period.
The calf circumference (Calf_circ) was obtained by averaging the greatest Calf_circ in bilateral legs. Intelligent movement analysis (eFitHealth, uCare Medical Electronics, Co. Ltd., Miaoli, Taiwan) using interactive voices and 3D depth image guides to assess 2-min step number, 5-time sit-to-stand duration, and chair sit-and-reach distance (Supplementary Data 1). Each of the above test was used to estimate VO2max (eV O2max), lower extremity muscle strength, and flexibility, respectively.21 Body composition, including total body water (TBW), mineral portion, protein amount (Prot), lean body mass (LBM), skeletal muscle mass (SKM), body fat mass (BFM), and basal metabolic rate (BMR) were measured by multiple frequency bioimpedance analysis (Inbody 720, Inbody Co., Ltd., CA, USA). The above measurements were documented before, 8-week after, and 24-week after initial visit.
RNA extraction Blood sampling of 10 ml whole blood from each subject at the recruitment, 8-week, and 24-week from the initial visit was placed in a tube containing 3.2% sodium citrate. Samples were then centrifuged at 360xg for 15 min, which supernatant was further centrifuged at 2400xg for 20 min at room temperature of 25 ℃ to keep plasma platelet count less than 2.5×10^8/ml. Processed plasma of 400 microL was placed in a 2mL eppendorf (Eppendorf corp. Hamburg, Germany) to mix with 1200 microL TRIzol (ThermoFisher Scientific Inc., Waltham, MA, USA) and 5 microL miR-39 (5x10^-15 mol/microL), exogenous control, of C. elegans as well as 2 microg (10 microg/mL in plasma) yeast RNA (Invitrogen, Carlsbad, CA, USA) for 15 min at room temperature. Another 320 microL chloroform was added and placed at room temperature for 5 min. The specimen was centrifuged at 12000 xg for 15 min at 4 ℃ and 300 microL colorless fluid layer was aspirated to mix with 900 microL iced 100% ethanol overnight at -80 ℃. The prepared specimen was placed into the Direct-zol column (Direct-zol RNA Miniprep, Zymo Research corp., Irvine, CA, USA) and was then centrifuged at 12000 xg for 30 sec. The column was then transferred to a new collection tube and was centrifuged at 12000 xg for 30 sec after mixing with 400 microL RNA wash buffer. DNase I reaction mix of 80 microL (DNase I enzyme 5 microL+DNA digestion buffer 75 microL) was added to the tube after discarding the RNA wash buffer and was incubated at room temperature for 15 min. Additional 400 microL pre-wash buffer was introduced into the tube and was centrifuged at 12000 xg for 30 sec. The column was then transferred into a new 1.5 mL RNase-free tube and was treated with 80 microL nuclease-free water at room temperature for 2min. The prepared sample was centrifuged at 12000 xg for 2 min to elute RNA solution.
Quantification of plasma microRNA levels miR-21, miR-126, miR-146a and miR-222 levels at the above three different time was analyzed. One-step real-time quantitative polymerase chain reaction (RT-qPCR) was performed using a RT-qPCR system (T100TM Thermal Cycler, Bio-Rad Laboratories Inc., Berkeley, CA, USA) to assess plasma microRNA levels. A mixture of 100 ng total RNA extraction, 10 microL TaqMan master mix (ThermoFisher), 5.8 microL nuclease-free water, 0.2 microL universal probe library 21 (10 microM), 0.1 microL RNase inhibitor, self-constructed 1 microL forward primers and 1 microL reverse primers for miR-39, miR-126 and miR-146a, and 2 microL cDNA template were created on ice. All reactions were incubated in a 48-well plate at 95°C for 3 min, followed by 40 cycles of 95°C for 5 sec, 60°C for 10 sec and 72°C for 1 sec. Self-constructed forward and reverse primer sequences for primary C. elegans miR-39 (C-miR-39) as exogenous control. Human miR-126 (miR-126) and miR-146a (miR-146a) (Supplementary Table 1) were normalized by the exogenous control and were used to determine the microRNA levels expressions during the follow-up.
miRCURY LNA SYBR Green PCR kit (Qiagen) was used to determine human miR-21 (miR-21) and miR-222 (miR-222). A mixture of 4 microL 5X miRCURY RT SYBR Green Reaction Buffer, 2 microL 10X miRCURY RT Wnzyme Mix and 14 microL of 100 ng total RNA extraction in nuclease-free water was incubated in a 48-well plate at 42°C for 60 min and followed by 95°C to generate cDNA. A mixture containing 2 microL C-miR-39 (or miR-21/ or miR-222) primers purchased from Qiagen, 10 microL miRCURY SYBR Green Master Mix, 2 microL nuclease-free water and 6 microL 5X generated cDNA template was incubated at 95°C for 2 min, followed by 40 cycles of 95°C for 10 sec and 56°C for 60 sec. has-miR-21 and hsa-miR-222 were normalized by the C-miR-39 and were used to determine the microRNA levels expressions during the follow-up.
Determination of inflammatory activity 300 microL of serum was diluted by 1:2 ratios. Loaded 50 microL of prepared samples per well and calibrators in duplicate onto the assay plate (Multiplex Human Cytokine Panel 1, Boster Biological Technology, Pleasanton, CA, USA). Each well containing antibodies captured IL-1α, IL-1β, IL-6, IL-10, and TNFα. A mixture that contains biotinylated analyte specific antibodies is added after washing away any unbound protein. The biotinylated antibodies completed the sandwich for each specific arrayed analyte. After washing away unbound biotinylated antibody, streptavidin horseradish peroxidase (SHRP) is added. Following an additional wash, the amount of SHRP remaining on each location of the array is proportional to the amount of the above initially captured cytokines. The amount of conjugated enzyme on each location of the array is measured with the addition of a chemiluminescent substrate.
Statistical analysis Data are presented as mean (95% CI) or n (%). Differences of continuous and nominal parameters and between the two groups were estimated by student-t and chi-square tests, respectively. Repeated measurement ANOVA was conducted to analyze differences of continuous parameters measured at the three time points in each group. Pearson correlation was performed to find the relationship between physical fitness and miRNAs. A p value less than 0.05 was considered as statistical significance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise training | Experimental | Behavioral: Supervised exercise training, Behavioral: Aerobic exercise trainingPre- and Post- exercise training effects. Part of the participants were randomly assigned to underwent additional 24 sessions of supervised exercise training (SET) and the remaining participants follow the above instruction without additional supervised exercise training. After the 24 sessions of SET, they were then followed a 16-week of follow-up of their daily activities without additional exercise training. |
| home exercise training | Active comparator | Behavioral: Aerobic exercise trainingAll included subjects were instructed to walk>=8000 steps per day (stp/d), which was recorded by wrist-worm smart watches |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary
- 1.Community-indwelling individuals with age>=55 years, who lived adjacent to a community hospital were surveyed.
- Secondary
- Adults with mini-mental state examination (MMSE) score > 24
- Negative lumbar spine as well as lower extremity degenerative joint disorder were recruited.
Key exclusion criteria (11 listed)
- unstable angina
- unstable BP
- severe aortic stenosis
- inflammatory disease within recent 3 months
- uncontrolled or severe cardiac dysrhythmias
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 |
|---|---|---|
| Supervised exercise trainingSET Participants underwent 24 sessions of moderate-intensity exercise training (MICT) at 70% maximum predicted heart rate for 30 min in each session | Behavioural | Supervised exercise training |
| Aerobic exercise trainingAll recruited subjects were instructed to walk >=8000 steps per day in the community. Part of the participants were randomly assigned to underwent additional 24 sessions of supervised aerobic exercise training (SET) with the intensity at 70% of maximum predicted heart rate and the remaining participants follow the above home exercise training (HET) instruction without additional supervised exercise training. | Behavioural | Supervised exercise training, home exercise training |
Primary outcome
walking steps per day (stp/d)
Time frame: 24 weeks
mean every day walking steps in a week measured by a wrist-worn smart watch
energy expenditure per day (Kcal/d)
Time frame: 24 weeks
mean every day energy consumption in a week estimated by a wrist-worn smart watch.
estimated maximum oxygen consumption (eVO2max)
Time frame: Initial recruitment
maximum energy consumption estimated from 2-min step numbers measured by an interactive voices and 3D depth imaging device.
estimated maximum oxygen consumption (eVO2max)
Time frame: 8 weeks after recruitment
maximum energy consumption estimated from 2-min step numbers measured by an interactive voices and 3D depth imaging device.
estimated maximum oxygen consumption (eVO2max)
Time frame: 24 weeks after recruitment
maximum energy consumption estimated from 2-min step numbers measured by an interactive voices and 3D depth imaging device.
Calf circumference (cm)
Time frame: Initial recruitment
Average maximum calf circumference of bilateral legs obtained by measuring tape.
Calf circumference (cm)
Time frame: 8 weeks after recruitment
Average maximum calf circumference of bilateral legs obtained by measuring tape.
Calf circumference (cm)
Time frame: 24 weeks after recruitment
Average maximum calf circumference of bilateral legs obtained by measuring tape.
5-time sit-to-stand duration (second)
Time frame: Initial recruitment
5-time sit-to-stand duration measured by an interactive voices and 3D depth imaging device.
5-time sit-to-stand duration (second)
Time frame: 8 weeks after recruitment
5-time sit-to-stand duration measured by an interactive voices and 3D depth imaging device.
5-time sit-to-stand duration (second)
Time frame: 24 weeks after recruitment
5-time sit-to-stand duration measured by an interactive voices and 3D depth imaging device.
Sit-and-reach distance (cm)
Time frame: Initial recruitment
Hand reaching distance while performing forward bending in a sitting position
Sit-and-reach distance (cm)
Time frame: 8 weeks after recruitment
Hand reaching distance while performing forward bending in a sitting position
Sit-and-reach distance (cm)
Time frame: 24 weeks after recruitment
Hand reaching distance while performing forward bending in a sitting position
Normalized total body water content (%)
Time frame: Initial recruitment
Total body water content obtained from bioimpedance measurement and was then normalized by body weight
Normalized total body water content (%)
Time frame: 8 weeks after recruitment
Total body water content obtained from bioimpedance measurement and was then normalized by body weight
Normalized total body water content (%)
Time frame: 24 weeks after recruitment
Total body water content obtained from bioimpedance measurement and was then normalized by body weight
Normalized total mineral content (%)
Time frame: Initial recruitment
Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.
Normalized total mineral content (%)
Time frame: 8 weeks after recruitment
Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.
Normalized total mineral content (%)
Time frame: 24 weeks after recruitment
Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.
Normalized total protein amount (%)
Time frame: Initial recruitment
Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.
Normalized total protein amount (%)
Time frame: 8 weeks after recruitment
Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.
Normalized total protein amount (%)
Time frame: 24 weeks after recruitment
Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.
Normalized body fat mass (%)
Time frame: Initial recruitment
Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.
Normalized body fat mass (%)
Time frame: 8 weeks after recruitment
Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.
Normalized body fat mass (%)
Time frame: 24 weeks after recruitment
Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.
Normalized skeletal mass to lean body mass percentage (%)
Time frame: Initial recruitment
Total skeletal mass obtained from bioimpedance measurement and was then normalized by lean body mass.
Normalized skeletal mass to lean body mass percentage (%)
Time frame: 8 weeks after recruitment
Total skeletal mass obtained from bioimpedance measurement and was then normalized by lean body mass.
Normalized skeletal mass to lean body mass percentage (%)
Time frame: 24 weeks after recruitment
Total skeletal mass obtained from bioimpedance measurement and was then normalized by lean body mass.
miR-21 (relative intensity)
Time frame: Initial recruitment
Ratio of human micro RNA 21 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-21 (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of human micro RNA 21 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-21 (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of human micro RNA 21 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-126 (relative intensity)
Time frame: Initial recruitment
Ratio of human micro RNA 126 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-126 (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of human micro RNA 126 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-126 (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of human micro RNA 126 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-146a (relative intensity)
Time frame: Initial recruitment
Ratio of human micro RNA 146a measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-146a (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of human micro RNA 146a measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-146a (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of human micro RNA 146a measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-222 (relative intensity)
Time frame: Initial recruitment
Ratio of human micro RNA 222 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-222 (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of human micro RNA 222 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
miR-222 (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of human micro RNA 222 measured by real-time quantitative polymerase chain reaction compared to the level of microRNA 39 of C. elegans.
IL-1a (relative intensity)
Time frame: Initial recruitment
Ratio of IL-1a obtained from ELISA assay plate at each time point to the baseline level.
IL-1a (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of IL-1a obtained from ELISA assay plate at each time point to the baseline level.
IL-1a (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of IL-1a obtained from ELISA assay plate at each time point to the baseline level.
IL-1b (relative intensity)
Time frame: Initial recruitment
Ratio of IL-1b obtained from ELISA assay plate at each time point to the baseline level.
IL-1b (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of IL-1b obtained from ELISA assay plate at each time point to the baseline level.
IL-1b (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of IL-1b obtained from ELISA assay plate at each time point to the baseline level.
IL-6 (relative intensity)
Time frame: Initial recruitment
Ratio of IL-6 obtained from ELISA assay plate at each time point to the baseline level.
IL-6 (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of IL-6 obtained from ELISA assay plate at each time point to the baseline level.
IL-6 (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of IL-6 obtained from ELISA assay plate at each time point to the baseline level.
IL-10 (relative intensity)
Time frame: Initial recruitment
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
IL-10 (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
IL-10 (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
TNFa (relative intensity)
Time frame: Initial recruitment
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
TNFa (relative intensity)
Time frame: 8 weeks after recruitment
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
TNFa (relative intensity)
Time frame: 24 weeks after recruitment
Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.
Physical component score (PCS)
Time frame: Initial recruitment
Physical role function obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Physical component score (PCS)
Time frame: 24 weeks after recruitment
Physical role function obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Mental component score (MCS)
Time frame: Initial recruitment
Mental health score obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Mental component score (MCS)
Time frame: 24 weeks after recruitment
Mental health score obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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 Jul 2022.
- Derived from this study: PubMed 38816804Huang LY, Lim AY, Hsu CC, Tsai YF, Fu TC, Shyu YC, Peng SC, Wang JS. Sustainability of exercise-induced benefits on circulating MicroRNAs and physical fitness in community-dwelling older adults: a randomized controlled trial with follow up. BMC Geriatr. 2024 May 30;24(1):473. doi: 10.1186/s12877-024-05084-0.
- Individual participant dataSharing planned: No
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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.
Chih-Chin Hsu, MD, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise training and Aerobic exercise training in people with Aging, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 11 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 Jul 2022. 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 Taiwan. 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?
walking steps per day (stp/d) (time frame: 24 weeks). The study lists 60 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940884, which also lists 1 linked publication.
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 Jul 2022.