HealthyNCT05862415
Concurrent Training for Optimal Physiological and Physical Benefits
A study testing therapeutic Exercise in people with Healthy and Physical Inactivity, run by Monira Aldhahi at 1 site in Saudi Arabia.
Trial summary
It is widely accepted that aerobic exercise and strengthen training are the core components of most workout programs. However, there is no clear consensus on whether the order in which the exercises are performed impacts their effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Physical Inactivity
- What is being tested?
- therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Aug 2022to 10 Apr 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- middle-aged adults ( over the age of 40)
- No history of cardiovascular or neuromuscular disorders
- not having orthopedic disorder or neurologic disorders.
Who cannot join
- adults using artificial prosthesis
- participation in any structured training program
- any disease that precludes exercise or necessitates special care (for example, coronary artery disease, thrombosis, moderate or severe bone disease, and lung or renal disease)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Princess Nourah bint Abdulrahman University
Riyadh, 11671
About this study
Official title: Impact of Two Types of Concurrent Training for Optimal Physiological and Physical Benefits in Middle-Aged Adults: a Randomized Controlled Trial
It is widely accepted that aerobic exercise and strengthen training are the core components of most workout programs. However, there is no clear consensus on whether the order in which the exercises are performed impacts their effectiveness. Therefore, the overarching aim of the study is to understand the optimal order of two types of concurrent training program for 13 weeks by comparing the effectiveness of the training on body composition, predicated maximal oxygen uptake (MaxVO2), dynamic respiratory parameters, and muscle strength in healthy middle-aged people. Methods:Thirty-three moderately-active middle-aged and healthy participants were randomly assigned to the strength+aerobic group (SAG, n = 16) and aerobic+strength group (ASG, n = 17). Body composition, aerobic endurance, respiratory parameters and upper and lower strength were assessed before (pre-test) and after (post-test) a 13-week intervention. The chi-square test and the independent t-test will be used to compare sociodemographic variables between the groups. A 2 x 2 analysis of variance (ANOVA) with repeated measures (group x measurement) will be conducted.
This study will enhance our understanding of the concurrent training effect on muscle composition and strength. These training programs allow for reducing the duration of the training, which can be an important factor in making adults more willing to participate in physical activity.
- Conditions
- Healthy, Physical Inactivity
- Being tested
- therapeutic Exercise
- Keywords
- Anaerobic work, Endurance, Aerobic training, Concurrent Training
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic ExerciseOther
The circular training method was used in the resistance training phase. During the aerobic training phase, a series of movements from moderate intensity to vigorous intensity was performed. The step loading periodization principle was taken into account in both resistance training and aerobic exercises.
The RT lasted approximately 20-25 min per session and included two sets of 8-20 repetitions, with a rest interval of 1-2 min. The RT exercises included: squat, barbell bent-over row, overhead press, plank, lateral pull down, triceps push down, barbell curl, leg extension, leg curl, lunge, barbell bench press, crunches etc.
For the aerobic training: Intensity was established between 50-65% and 80-85% of HRmax for both groups (SAG and ASG). Aerobic training includes walking and running periods and was carried out on a 400 m outdoor track. In periodization, especially 1st-4th.
| Study group | Role | What they receive |
|---|---|---|
| strength+aerobic group (SAG) | Active comparator | All training sessions began with a 5- to 7-minute warm- up (consisting low-intensity walking and running, and dynamic mobility exercises) and active recovery of 4- to 5-minute (based on stretching and relaxation exercises). Sessions lasted approximately 50 minutes (warm-up and cold down included), with an overall weekly volume of 105-120 minutes.
The circular training method was used in the resistance training phase. During the aerobic training phase, a series of movements from moderate intensity to vigorous intensity was performed.
The RT lasted approximately 20-25 min per session and included two sets of 8-20 repetitions, with a rest interval of 1-2 min. The resistance training program was performed using the circuit training method in which two or three sets were performed. The RT exercises included: squat, barbell bent-over row, overhead press, plank, lateral pull down, triceps push down, barbell curl, leg extension, leg curl, lunge, barbell bench press, crunches etc. Receives: Other: therapeutic Exercise |
| aerobic+strength group (ASG) | Experimental | Similar to the active comparator group, but the order of the training reverse. Receives: Other: therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat %
To measure the BF%, a bioelectrical impedance analysis was used. The participants will be instructed to stand barefoot on the bioelectrical impedance analysis devices (seca mBCA 515, Hamburg, Germany).The device measures the body composition and includes a platform with handrails and electrodes that measure the impedance passed through the pairs of hands and feet while standing. Impedance was measured over 75 s with a current of 100 μA at a frequency range between 1 kHz and 1000 kHz and a capacity of 360 kg. Waist circumference measurement at the umbilicus and level physical activity level were inputted to indirectly estimate the body composition.
Measured: 10 min
Predicated maximal oxygen uptake (MaxVO2)
1-mile walk-run performance test was used. The aim of this test is to cover a distance of one mile in the shortest possible time. Participants can alternate between walking and running as desired; however, they should be encouraged to cover the distance as quickly as feasible. The time elapsed to cover a mile distance, measured in minutes and seconds. During the testing and recovery the heart rate of the participants was monitored with a heart rate sensor (Polar Verity Sense; Kempele, Finland). Polar Verity Sense can be connected to a sports watch or app via Bluetooth®, ANT+, and internal memory to instantly track your training or view the data after training. As a result, the participant's time for completing the 1-mile test was tracked using a smart phone GPS system. The validity of the device has previously been reported previously[27]. The participants' MaxVO2 values were calculated using the formulas below.
Measured: 1 day
Forced Vital Capacity (FVC)
a spirometer device (Minispir®, PC-based Spirometer with Oximetry option, Italy) will be used to measure the Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1).
Measured: 1 day
Forced Expiratory Volume in One Second
a spirometer device (Minispir®, PC-based Spirometer with Oximetry option, Italy) will be used to measure the Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1).
Measured: 1 day
Grip Strength
A handgrip dynamometer was used to measure the strength of the hand and forearm muscles (in kilograms) (Tanita Handgrip Meter, RM40, East Malaysia). The test was carried out with the elbow fully extended and the forearm in a neutral position. At 1-minute intervals, three measurements were taken on the subjects' dominant side. The participants were instructed to told the handgrip of the device tightly for 3 seconds[30]. For statistical analysis, the highest scores from three measurements were taken.
Measured: 1 day
1-Repetition Maximum Strength
The indirect 1 repetition maximum (1RM) test is relatively simple, efficient, and safe when used and administered. The maximum repetition between 2 and 20 for any weight can be used to indirectly compute the 1RM value using the calculations. The formulas for calculating 1RM allow for weightlifting repetitions of less than 20 and a linear or curved relationship between the percentages of 1RMI. In order to determine the 1RM values of the study participants, indirect 1RM bench press, leg press, long pulley, leg extension, and overhead press were used. 1RM tests were performed using a weight machine (Technogym Selection 900).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start10 Aug 2022
- Primary completion10 Feb 2023
- Study completion10 Apr 2023
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 HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monira Aldhahi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monira Aldhahi, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862415
- Sponsor's protocol ID
- 198511
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Canli U, Aldhahi MI. The physiological and physical benefits of two types of concurrent training: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 Jan 2;16(1):8. doi: 10.1186/s13102-023-00798-x.
PubMed 38169423
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Types of Concurrent Training for Optimal Physiological and Physical Benefits in Middle-Aged Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05862415
- Acronym / sponsor ID
- 198511
- Conditions
- Healthy, Physical Inactivity
- Keywords
- Anaerobic work, Endurance, Aerobic training, Concurrent Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Monira AldhahiUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 17 May 2023 (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.
It is widely accepted that aerobic exercise and strengthen training are the core components of most workout programs. However, there is no clear consensus on whether the order in which the exercises are performed impacts their effectiveness. Therefore, the overarching aim of the study is to understand the optimal order of two types of concurrent training program for 13 weeks by comparing the effectiveness of the training on body composition, predicated maximal oxygen uptake (MaxVO2), dynamic respiratory parameters, and muscle strength in healthy middle-aged people. Methods:Thirty-three moderately-active middle-aged and healthy participants were randomly assigned to the strength+aerobic group (SAG, n = 16) and aerobic+strength group (ASG, n = 17). Body composition, aerobic endurance, respiratory parameters and upper and lower strength were assessed before (pre-test) and after (post-test) a 13-week intervention. The chi-square test and the independent t-test will be used to compare sociodemographic variables between the groups. A 2 x 2 analysis of variance (ANOVA) with repeated measures (group x measurement) will be conducted.
This study will enhance our understanding of the concurrent training effect on muscle composition and strength. These training programs allow for reducing the duration of the training, which can be an important factor in making adults more willing to participate in physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strength+aerobic group (SAG) | Active comparator | Other: therapeutic ExerciseAll training sessions began with a 5- to 7-minute warm- up (consisting low-intensity walking and running, and dynamic mobility exercises) and active recovery of 4- to 5-minute (based on stretching and relaxation exercises). Sessions lasted approximately 50 minutes (warm-up and cold down included), with an overall weekly volume of 105-120 minutes. The circular training method was used in the resistance training phase. During the aerobic training phase, a series of movements from moderate intensity to vigorous intensity was performed. The RT lasted approximately 20-25 min per session and included two sets of 8-20 repetitions, with a rest interval of 1-2 min. The resistance training program was performed using the circuit training method in which two or three sets were performed. The RT exercises included: squat, barbell bent-over row, overhead press, plank, lateral pull down, triceps push down, barbell curl, leg extension, leg curl, lunge, barbell bench press, crunches etc. |
| aerobic+strength group (ASG) | Experimental | Other: therapeutic ExerciseSimilar to the active comparator group, but the order of the training reverse. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- middle-aged adults ( over the age of 40)
- No history of cardiovascular or neuromuscular disorders
- not having orthopedic disorder or neurologic disorders.
Key exclusion criteria (3 listed)
- adults using artificial prosthesis
- participation in any structured training program
- any disease that precludes exercise or necessitates special care (for example, coronary artery disease, thrombosis, moderate or severe bone disease, and lung or renal disease)
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 |
|---|---|---|
| therapeutic ExerciseThe circular training method was used in the resistance training phase. During the aerobic training phase, a series of movements from moderate intensity to vigorous intensity was performed. The step loading periodization principle was taken into account in both resistance training and aerobic exercises. The RT lasted approximately 20-25 min per session and included two sets of 8-20 repetitions, with a rest interval of 1-2 min. The RT exercises included: squat, barbell bent-over row, overhead press, plank, lateral pull down, triceps push down, barbell curl, leg extension, leg curl, lunge, barbell bench press, crunches etc. For the aerobic training: Intensity was established between 50-65% and 80-85% of HRmax for both groups (SAG and ASG). Aerobic training includes walking and running periods and was carried out on a 400 m outdoor track. In periodization, especially 1st-4th. | Other | aerobic+strength group (ASG), strength+aerobic group (SAG) |
Primary outcome
Body fat %
Time frame: 10 min
To measure the BF%, a bioelectrical impedance analysis was used. The participants will be instructed to stand barefoot on the bioelectrical impedance analysis devices (seca mBCA 515, Hamburg, Germany).The device measures the body composition and includes a platform with handrails and electrodes that measure the impedance passed through the pairs of hands and feet while standing. Impedance was measured over 75 s with a current of 100 μA at a frequency range between 1 kHz and 1000 kHz and a capacity of 360 kg. Waist circumference measurement at the umbilicus and level physical activity level were inputted to indirectly estimate the body composition.
Predicated maximal oxygen uptake (MaxVO2)
Time frame: 1 day
1-mile walk-run performance test was used. The aim of this test is to cover a distance of one mile in the shortest possible time. Participants can alternate between walking and running as desired; however, they should be encouraged to cover the distance as quickly as feasible. The time elapsed to cover a mile distance, measured in minutes and seconds. During the testing and recovery the heart rate of the participants was monitored with a heart rate sensor (Polar Verity Sense; Kempele, Finland). Polar Verity Sense can be connected to a sports watch or app via Bluetooth®, ANT+, and internal memory to instantly track your training or view the data after training. As a result, the participant's time for completing the 1-mile test was tracked using a smart phone GPS system. The validity of the device has previously been reported previously[27]. The participants' MaxVO2 values were calculated using the formulas below.
Forced Vital Capacity (FVC)
Time frame: 1 day
a spirometer device (Minispir®, PC-based Spirometer with Oximetry option, Italy) will be used to measure the Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1).
Forced Expiratory Volume in One Second
Time frame: 1 day
a spirometer device (Minispir®, PC-based Spirometer with Oximetry option, Italy) will be used to measure the Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1).
Grip Strength
Time frame: 1 day
A handgrip dynamometer was used to measure the strength of the hand and forearm muscles (in kilograms) (Tanita Handgrip Meter, RM40, East Malaysia). The test was carried out with the elbow fully extended and the forearm in a neutral position. At 1-minute intervals, three measurements were taken on the subjects' dominant side. The participants were instructed to told the handgrip of the device tightly for 3 seconds[30]. For statistical analysis, the highest scores from three measurements were taken.
1-Repetition Maximum Strength
Time frame: 1 day
The indirect 1 repetition maximum (1RM) test is relatively simple, efficient, and safe when used and administered. The maximum repetition between 2 and 20 for any weight can be used to indirectly compute the 1RM value using the calculations. The formulas for calculating 1RM allow for weightlifting repetitions of less than 20 and a linear or curved relationship between the percentages of 1RMI. In order to determine the 1RM values of the study participants, indirect 1RM bench press, leg press, long pulley, leg extension, and overhead press were used. 1RM tests were performed using a weight machine (Technogym Selection 900).
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 17 May 2023.
- Derived from this study: PubMed 38169423Canli U, Aldhahi MI. The physiological and physical benefits of two types of concurrent training: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 Jan 2;16(1):8. doi: 10.1186/s13102-023-00798-x.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic Exercise in people with Healthy and Physical Inactivity, run by Monira Aldhahi at 1 site in Saudi Arabia.
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 3 inclusion and 3 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 17 May 2023. 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 Saudi Arabia. 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?
Body fat % (time frame: 10 min). The study lists 6 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 NCT05862415, 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 17 May 2023.