Supervised Exercise Training Effects on Older Community Dwellers

NCT04940884 | Completed

• 1 other identifier: 201602058A3C502
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aging

Keywords

aerobic exercise; physical fitness; body compositions; micro rna

Outcome Measures

Primary Outcomes (60)

• walking steps per day (stp/d)

  mean every day walking steps in a week measured by a wrist-worn smart watch

  24 weeks

• energy expenditure per day (Kcal/d)

  mean every day energy consumption in a week estimated by a wrist-worn smart watch.

  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.

  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.

  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.

  24 weeks after recruitment

• Calf circumference (cm)

  Average maximum calf circumference of bilateral legs obtained by measuring tape.

  Initial recruitment

• Calf circumference (cm)

  Average maximum calf circumference of bilateral legs obtained by measuring tape.

  8 weeks after recruitment

• Calf circumference (cm)

  Average maximum calf circumference of bilateral legs obtained by measuring tape.

  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.

  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.

  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.

  24 weeks after recruitment

• Sit-and-reach distance (cm)

  Hand reaching distance while performing forward bending in a sitting position

  Initial recruitment

• Sit-and-reach distance (cm)

  Hand reaching distance while performing forward bending in a sitting position

  8 weeks after recruitment

• Sit-and-reach distance (cm)

  Hand reaching distance while performing forward bending in a sitting position

  24 weeks after recruitment

• Normalized total body water content (%)

  Total body water content obtained from bioimpedance measurement and was then normalized by body weight

  Initial recruitment

• Normalized total body water content (%)

  Total body water content obtained from bioimpedance measurement and was then normalized by body weight

  8 weeks after recruitment

• Normalized total body water content (%)

  Total body water content obtained from bioimpedance measurement and was then normalized by body weight

  24 weeks after recruitment

• Normalized total mineral content (%)

  Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.

  Initial recruitment

• Normalized total mineral content (%)

  Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.

  8 weeks after recruitment

• Normalized total mineral content (%)

  Total body mineral content obtained from bioimpedance measurement and was then normalized by body weight.

  24 weeks after recruitment

• Normalized total protein amount (%)

  Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.

  Initial recruitment

• Normalized total protein amount (%)

  Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.

  8 weeks after recruitment

• Normalized total protein amount (%)

  Total body protein amount obtained from bioimpedance measurement and was then normalized by body weight.

  24 weeks after recruitment

• Normalized body fat mass (%)

  Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.

  Initial recruitment

• Normalized body fat mass (%)

  Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.

  8 weeks after recruitment

• Normalized body fat mass (%)

  Total body fat amount obtained from bioimpedance measurement and was then normalized by body weight.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Initial recruitment

• IL-1a (relative intensity)

  Ratio of IL-1a obtained from ELISA assay plate at each time point to the baseline level.

  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.

  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.

  Initial recruitment

• IL-1b (relative intensity)

  Ratio of IL-1b obtained from ELISA assay plate at each time point to the baseline level.

  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.

  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.

  Initial recruitment

• IL-6 (relative intensity)

  Ratio of IL-6 obtained from ELISA assay plate at each time point to the baseline level.

  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.

  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.

  Initial recruitment

• IL-10 (relative intensity)

  Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.

  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.

  24 weeks after recruitment

• TNFa (relative intensity)

  Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.

  Initial recruitment

• TNFa (relative intensity)

  Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.

  8 weeks after recruitment

• TNFa (relative intensity)

  Ratio of IL-10 obtained from ELISA assay plate at each time point to the baseline level.

  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.

  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.

  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.

  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.

  24 weeks after recruitment

Study Arms (2)

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.

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

Behavioral: Aerobic exercise training

Interventions

Supervised exercise training BEHAVIORAL

SET Participants underwent 24 sessions of moderate-intensity exercise training (MICT) at 70% maximum predicted heart rate for 30 min in each session

Supervised exercise training

Aerobic exercise training BEHAVIORAL

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.

Supervised exercise training; home exercise training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary
• 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.

You may not qualify if:

• unstable angina
• unstable BP
• severe aortic stenosis
• inflammatory disease within recent 3 months
• uncontrolled or severe cardiac dysrhythmias
• uncompensated HF
• 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.)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Study Officials

• Chih-Chin Hsu, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 28, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)