NCT06160089

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2024

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 6, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before the first training session and one week after the last training session

Secondary Outcomes (5)

  • Muscle power during the concentric

    Before the first training session and one week after the last training session

  • Balance

    Before the first training session and one week after the last training session

  • Risk of falls

    Before the first training session and one week after the last training session

  • Walking speed

    Before the first training session and one week after the last training session

  • Lower limb functionality

    Before the first training session and one week after the last training session

Study Arms (2)

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.

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.

Other: Isoinertial training

Interventions

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.

Isoinertial group

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.

Gravitational group

Eligibility Criteria

Age57 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Acute Osteoarticular injuries
  • Acute musculoskeletal injuries
  • Systemic diseases
  • Neurodegenerative diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08197, Spain

RECRUITING

Central Study Contacts

Aida Cadellans Arroniz, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 6, 2023

First Posted

December 7, 2023

Study Start

November 10, 2023

Primary Completion

December 22, 2023

Study Completion

March 8, 2024

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations