AgedNCT06160089
Effectiveness of Iso-inertial Resistance Training in Physically Active Older Adults
A study testing Isoinertial training and Gravitational training in people with Aged and Muscle Strength, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Strength training is effective for promoting longevity. The iso-inertial training method is an innovative way to improve strength, but it is unclear whether it improves muscle power and functional variables that are key to develop activities of daily living. Read more about this study
- Who is it for?
- Ages 57 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged, Muscle Strength, Resistance Training
- What is being tested?
- Isoinertial training and Gravitational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2023to 8 Mar 2024
- 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 57 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 60 or more.
- Adults physically active. By "physically active" we consider that they are enrolled in the gymnasium Espai Esport Wellness Centre and that they make use of their facilities with varying frequency in the months prior to the start of the study.
Who cannot join
- Acute Osteoarticular injuries
- Acute musculoskeletal injuries
- Systemic diseases
- Neurodegenerative diseases
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08197
Aida Cadellans Arroniz, PhD, 635246977, acadellans@uic.es
Aida Cadellans Arroniz, 635246977, acadellans@uic.es
About this study
Official title: Effectiveness of Iso-inertial Resistance Training on the Muscle Power of the Lower Limbs, Physical Aptitude, and Risk of Falls in Physically Active Older Adults: a Randomised Controlled Trial
Strength training is effective for promoting longevity. The iso-inertial training method is an innovative way to improve strength, but it is unclear whether it improves muscle power and functional variables that are key to develop activities of daily living. The purpose of this study is to conduct a randomised controlled trial at the gymnasium Espai Esport Wellness Center (Granollers) involving physically active older adults (age ≥60). Our goal is to evaluate the effectiveness of a 6-week iso-inertial strength program on the muscle power, physical fitness and risk of falls compared to executing that program with a traditional gravitational strength method. Providing older adults with new, effective methods to preserve their functional capacities is essential for longevity. Also, bringing them into an active environment could encourage a healthier lifestyle and reduce the risk of physical and mental diseases.
Read the detailed description
With the progressive increase in life expectancy of the population, attention to ageing has gained special interest in recent years. Actions aimed at promoting healthy ageing in the older adults are key to slow down the physiological progressive loss in skeletal muscle mass, quality and function as the person ages. These losses affect the individual's ability to carry out activities of daily living. More concretely, the muscle strength and power are reduced during aging, which has a negative impact on the functional capacity and quality of life of older adults. In fact, recent research has identified a significant decrease in muscle strength of 1-1.5% each year from the age of 50. While the muscle strength is defined as the ability to generate intramuscular tension when facing a resistance, regardless of whether it generates movement, the muscle power is defined as the maximum amount of force one can generate during a specific movement at a specified velocity. Previous studies report that muscle power is diminished to a greater extent than strength over time. Muscle power is considered a predictor of functional capacity, as it is associated with activities of daily living such as climbing stairs, standing up from a chair or walking. This fact has justified the use of strength and power training in different studies that aim to prevent the risk of falls, improve the balance or the walking capacity in older adults.
Resistance training (RT) is one of the main strategies to prevent the decrease in functional capacities and has demonstrated its effectiveness in combating age-induced muscle atrophy (sarcopenia), risk of falls, and fragility. RT has also been shown to improve cardiovascular health. Regarding the types of RT, previous studies have noted statistically significant differences in favor of eccentric training, when comparing it with concentric RT. Specifically, it has been observed that eccentric training leads to higher peak strength with lower muscle activation and lower metabolic cost, increased muscle mass and higher jumping performance. Thus, the values of muscle strength and power resulting from an eccentric RT are physiologically superior to those obtained when performing concentric RT.
The most traditionally used RT method in the field of community health is the one known as gravitational, in which a resistance is opposed through free weights or by blocks or disks in cable machines. One of the main restrictions of this method is that the workload applied during the shortening-longing cycle of a repetition is limited to concentric muscle capacity and does not allow a progression of the eccentric workload. This fact limits the potential of this method for generating the improvements associated with eccentric training mentioned above. In contrast, the iso-inertial (ISI) training method is based on the application of resistance generated by an iso-inertial device, where the workload is provided by the inertia of a rotating mass. Unlike the gravitational system, the ISI method can provide a resistance workload in the eccentric phase that is proportional to the concentric phase. Thanks to that, high workloads can be applied for both phases. Another benefit of ISI method is that, when the load increases or the fatigue appears, only the execution speed is reduced but the execution is not interrupted .
Different studies show that eccentric overload training protocols (i.e., with a higher force in the eccentric phase of a repetition) improve muscle hypertrophy and power, as well as and neuromuscular functions. Because of its force-generating system, the ISI method is ideal for eccentric overload compared to gravitational systems, where eccentric overload can only be achieved with external assistance. Also, the ISI method allows a fluid movement compared to the interrupted movements of gravitational systems.
Recent studies have reported improvements in postural control or maximal isometric strength with ISI training in older adults. Also for metabolic variables such as lipid profile or maximum oxygen volume consumption . However, no study has been found that compares the effects of ISI and gravitational training on muscle power and other relevant functional variables in older adults. This is of critical importance because of the direct implications that the improvements of muscle power has on activities of the daily live.
The main objective of this study is to evaluate the effectiveness of an iso-inertial resistance training program on the eccentric muscle power of the lower limbs compared to the same program executed with gravitational resistance in physically active older adults. The secondary objectives are 1) to evaluate the effectiveness of an iso-inertial resistance training program on the concentric muscle power, physical fitness (balance, walking speed and functionality of the lower limbs), and risk of falls compared to the same program executed with gravitational resistance in physically active older adults, and 2) to assess the differences between men and women for the previous objectives.
- Conditions
- Aged, Muscle Strength, Resistance Training
- Being tested
- Isoinertial training, Gravitational training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoinertial trainingOther
For the front lunge and the front lunge with hand grip pull, the participant will be placed frontally on the training device (inertial). Whereas for the side lunge the participant will be placed sideways on the device (homolateral on the scrolling limb). For front and side lunge, a weight shift belt will be used, which will be placed on the waist. For the frontal lunge with hand grip pull, the grip is performed with the upper limb homolateral to the displaced lower limb. The volume and difficulty of execution of the exercises will increase over time. Investigators will instruct the participants to perform the exercises at a given intensity according to the Borg Rating of Perceived Exertion (RPE) scale. The intensity will increase throughout the training program.
Gravitational trainingOther
For the front lunge and the front lunge with hand grip pull, the participant will be placed frontally on the training device (gravitational). Whereas for the side lunge the participant will be placed sideways on the device (homolateral on the scrolling limb). For front and side lunge, a weight shift belt will be used, which will be placed on the waist. For the frontal lunge with hand grip pull, the grip is performed with the upper limb homolateral to the displaced lower limb. The volume and difficulty of execution of the exercises will increase over time. Investigators will instruct the participants to perform the exercises at a given intensity according to the Borg Rating of Perceived Exertion (RPE) scale. The intensity will increase throughout the training program.
| Study group | Role | What they receive |
|---|---|---|
| Gravitational group | Active comparator | Participants will have to perform a 6-week programme based on three exercises: front lunge, side lunge, and front lunge with hand grip pull, that will be the basis of each session. Exercices will be performed with the gravitational device. Receives: Other: Gravitational training |
| Isoinertial group | Experimental | Participants will have to perform a 6-week programme based on three exercises: front lunge, side lunge, and front lunge with hand grip pull, that will be the basis of each session. Exercices will be performed with the isoinertial device. Receives: Other: Isoinertial training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle power during the eccentric
Muscle power during the eccentric phase measured with both iso-inertial and gravitational devices, measured with a rotatory and a linear encoder (Chronojump Boscosystem®), respectively.
Measured: Before the first training session and one week after the last training session
Secondary outcomes (5)
Muscle power during the concentric
Muscle power during the concentric phase measured with both iso-inertial and gravitational devices (measured with the encoders mentioned above)
Measured: Before the first training session and one week after the last training session
Balance
Tandem and semitandem test, measured in seconds
Measured: Before the first training session and one week after the last training session
Risk of falls
Get up and go test, measured in seconds
Measured: Before the first training session and one week after the last training session
Walking speed
4 meters walking test, measured in seconds
Measured: Before the first training session and one week after the last training session
Lower limb functionality
5 times sit to stand test, measured in seconds
Measured: Before the first training session and one week after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start10 Nov 2023
- Primary completion22 Dec 2023 (estimated)
- Study completion8 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel group, randomized controlled trial (allocation ratio 1:1) with blinded outcome assessment where participants will be randomly assigned to one of the two study groups (iso-inertial or gravitational resistance training).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aïda Cadellans-Arróniz, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160089
- Sponsor's protocol ID
- FIS-2023-03
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Iso-inertial Resistance Training on the Muscle Power of the Lower Limbs, Physical Aptitude, and Risk of Falls in Physically Active Older Adults: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06160089
- Acronym / sponsor ID
- FIS-2023-03
- Conditions
- Aged, Muscle Strength, Resistance Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 8 Mar 2024 (estimated)
- First posted
- 7 Dec 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.
Strength training is effective for promoting longevity. The iso-inertial training method is an innovative way to improve strength, but it is unclear whether it improves muscle power and functional variables that are key to develop activities of daily living. The purpose of this study is to conduct a randomised controlled trial at the gymnasium Espai Esport Wellness Center (Granollers) involving physically active older adults (age ≥60). Our goal is to evaluate the effectiveness of a 6-week iso-inertial strength program on the muscle power, physical fitness and risk of falls compared to executing that program with a traditional gravitational strength method. Providing older adults with new, effective methods to preserve their functional capacities is essential for longevity. Also, bringing them into an active environment could encourage a healthier lifestyle and reduce the risk of physical and mental diseases.
Detailed description
With the progressive increase in life expectancy of the population, attention to ageing has gained special interest in recent years. Actions aimed at promoting healthy ageing in the older adults are key to slow down the physiological progressive loss in skeletal muscle mass, quality and function as the person ages. These losses affect the individual's ability to carry out activities of daily living. More concretely, the muscle strength and power are reduced during aging, which has a negative impact on the functional capacity and quality of life of older adults. In fact, recent research has identified a significant decrease in muscle strength of 1-1.5% each year from the age of 50. While the muscle strength is defined as the ability to generate intramuscular tension when facing a resistance, regardless of whether it generates movement, the muscle power is defined as the maximum amount of force one can generate during a specific movement at a specified velocity. Previous studies report that muscle power is diminished to a greater extent than strength over time. Muscle power is considered a predictor of functional capacity, as it is associated with activities of daily living such as climbing stairs, standing up from a chair or walking. This fact has justified the use of strength and power training in different studies that aim to prevent the risk of falls, improve the balance or the walking capacity in older adults.
Resistance training (RT) is one of the main strategies to prevent the decrease in functional capacities and has demonstrated its effectiveness in combating age-induced muscle atrophy (sarcopenia), risk of falls, and fragility. RT has also been shown to improve cardiovascular health. Regarding the types of RT, previous studies have noted statistically significant differences in favor of eccentric training, when comparing it with concentric RT. Specifically, it has been observed that eccentric training leads to higher peak strength with lower muscle activation and lower metabolic cost, increased muscle mass and higher jumping performance. Thus, the values of muscle strength and power resulting from an eccentric RT are physiologically superior to those obtained when performing concentric RT.
The most traditionally used RT method in the field of community health is the one known as gravitational, in which a resistance is opposed through free weights or by blocks or disks in cable machines. One of the main restrictions of this method is that the workload applied during the shortening-longing cycle of a repetition is limited to concentric muscle capacity and does not allow a progression of the eccentric workload. This fact limits the potential of this method for generating the improvements associated with eccentric training mentioned above. In contrast, the iso-inertial (ISI) training method is based on the application of resistance generated by an iso-inertial device, where the workload is provided by the inertia of a rotating mass. Unlike the gravitational system, the ISI method can provide a resistance workload in the eccentric phase that is proportional to the concentric phase. Thanks to that, high workloads can be applied for both phases. Another benefit of ISI method is that, when the load increases or the fatigue appears, only the execution speed is reduced but the execution is not interrupted .
Different studies show that eccentric overload training protocols (i.e., with a higher force in the eccentric phase of a repetition) improve muscle hypertrophy and power, as well as and neuromuscular functions. Because of its force-generating system, the ISI method is ideal for eccentric overload compared to gravitational systems, where eccentric overload can only be achieved with external assistance. Also, the ISI method allows a fluid movement compared to the interrupted movements of gravitational systems.
Recent studies have reported improvements in postural control or maximal isometric strength with ISI training in older adults. Also for metabolic variables such as lipid profile or maximum oxygen volume consumption . However, no study has been found that compares the effects of ISI and gravitational training on muscle power and other relevant functional variables in older adults. This is of critical importance because of the direct implications that the improvements of muscle power has on activities of the daily live.
The main objective of this study is to evaluate the effectiveness of an iso-inertial resistance training program on the eccentric muscle power of the lower limbs compared to the same program executed with gravitational resistance in physically active older adults. The secondary objectives are 1) to evaluate the effectiveness of an iso-inertial resistance training program on the concentric muscle power, physical fitness (balance, walking speed and functionality of the lower limbs), and risk of falls compared to the same program executed with gravitational resistance in physically active older adults, and 2) to assess the differences between men and women for the previous objectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel group, randomized controlled trial (allocation ratio 1:1) with blinded outcome assessment where participants will be randomly assigned to one of the two study groups (iso-inertial or gravitational resistance training).
| Arm | Type | Receives |
|---|---|---|
| Gravitational group | Active comparator | Other: Gravitational trainingParticipants will have to perform a 6-week programme based on three exercises: front lunge, side lunge, and front lunge with hand grip pull, that will be the basis of each session. Exercices will be performed with the gravitational device. |
| Isoinertial group | Experimental | Other: Isoinertial trainingParticipants will have to perform a 6-week programme based on three exercises: front lunge, side lunge, and front lunge with hand grip pull, that will be the basis of each session. Exercices will be performed with the isoinertial device. |
Who may qualify
- Ages
- 57 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 60 or more.
- Adults physically active. By "physically active" we consider that they are enrolled in the gymnasium Espai Esport Wellness Centre and that they make use of their facilities with varying frequency in the months prior to the start of the study.
Key exclusion criteria (4 listed)
- Acute Osteoarticular injuries
- Acute musculoskeletal injuries
- Systemic diseases
- Neurodegenerative diseases
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 |
|---|---|---|
| Isoinertial trainingFor the front lunge and the front lunge with hand grip pull, the participant will be placed frontally on the training device (inertial). Whereas for the side lunge the participant will be placed sideways on the device (homolateral on the scrolling limb). For front and side lunge, a weight shift belt will be used, which will be placed on the waist. For the frontal lunge with hand grip pull, the grip is performed with the upper limb homolateral to the displaced lower limb. The volume and difficulty of execution of the exercises will increase over time. Investigators will instruct the participants to perform the exercises at a given intensity according to the Borg Rating of Perceived Exertion (RPE) scale. The intensity will increase throughout the training program. | Other | Isoinertial group |
| Gravitational trainingFor the front lunge and the front lunge with hand grip pull, the participant will be placed frontally on the training device (gravitational). Whereas for the side lunge the participant will be placed sideways on the device (homolateral on the scrolling limb). For front and side lunge, a weight shift belt will be used, which will be placed on the waist. For the frontal lunge with hand grip pull, the grip is performed with the upper limb homolateral to the displaced lower limb. The volume and difficulty of execution of the exercises will increase over time. Investigators will instruct the participants to perform the exercises at a given intensity according to the Borg Rating of Perceived Exertion (RPE) scale. The intensity will increase throughout the training program. | Other | Gravitational group |
Primary outcome
Muscle power during the eccentric
Time frame: Before the first training session and one week after the last training session
Muscle power during the eccentric phase measured with both iso-inertial and gravitational devices, measured with a rotatory and a linear encoder (Chronojump Boscosystem®), respectively.
5 secondary outcomes
Muscle power during the concentric
Time frame: Before the first training session and one week after the last training session
Balance
Time frame: Before the first training session and one week after the last training session
Risk of falls
Time frame: Before the first training session and one week after the last training session
Walking speed
Time frame: Before the first training session and one week after the last training session
Lower limb functionality
Time frame: Before the first training session and one week after the last training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoinertial training and Gravitational training in people with Aged and Muscle Strength, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Dec 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aida Cadellans Arroniz, Dr. (635246977, acadellans@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle power during the eccentric (time frame: Before the first training session and one week after the last training session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2023.