- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06160089
Effectiveness of Iso-inertial Resistance Training in Physically Active Older Adults
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aida Cadellans Arroniz, Dr.
- Phone Number: 635246977
- Email: acadellans@uic.es
Study Locations
-
-
Barcelona
-
Sant Cugat Del Vallès, Barcelona, Spain, 08197
- Recruiting
- Universitat Internacional de Catalunya
-
Contact:
- Aida Cadellans Arroniz, PhD
- Phone Number: 635246977
- Email: acadellans@uic.es
-
Contact:
- Aida Cadellans Arroniz
- Phone Number: 635246977
- Email: acadellans@uic.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Acute Osteoarticular injuries
- Acute musculoskeletal injuries
- Systemic diseases
- Neurodegenerative diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gravitational group
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.
|
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.
|
Experimental: Isoinertial group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before the first training session and one week after the last training session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle power during the concentric
Time Frame: Before the first training session and one week after the last training session
|
Muscle power during the concentric phase measured with both iso-inertial and gravitational devices (measured with the encoders mentioned above)
|
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
|
Tandem and semitandem test, measured in seconds
|
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
|
Get up and go test, measured in seconds
|
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
|
4 meters walking test, measured in seconds
|
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
|
5 times sit to stand test, measured in seconds
|
Before the first training session and one week after the last training session
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FIS-2023-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aged
-
Samsung ElectronicsCompletedAged | Adults | Middle Age | Aged, 80 and OverKorea, Republic of
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingAged | Patient Safety | Aged, 80 and Over | Restraint, PhysicalSpain
-
University Hospital, ToulouseNot yet recruiting
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Education University of Hong KongRecruiting
-
Abbott NutritionCompleted
-
Pontificia Universidad Catolica de ChileNot yet recruiting
-
National Yang Ming UniversityCompleted
Clinical Trials on Gravitational training
-
ASST Fatebenefratelli SaccoRegione LombardiaCompletedAutonomic Nervous System Dysfunction in Critically IllItaly
-
University of Trás-os-Montes and Alto DouroCompletedLipid Metabolism Disorders | Sarcopenia | Osteoporosis | Overweight and Obesity | Personal Satisfaction | Hypertension With Complications and Secondary HypertensionPortugal
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedHypertension | Diabetes | Peripheral Arterial DiseaseBrazil
-
New Jersey Institute of TechnologyRutgers, The State University of New JerseyCompletedHemiplegia | Hemiparesis | Cerebrovascular AccidentUnited States
-
Riphah International UniversityRecruiting
-
University of PittsburghEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Lebanese UniversityCompletedHeart Failure | Quality of Life | Cardiac Rehabilitation | Aerobic Exercise | Exercise Intolerance | Respiratory Muscle Training | Strength Training