Effects of Inspiratory Muscle Fatigue and Warm-up on Respiratory Variables, Handgrip Strength, and Walking Capacity in Sedentary Older Adults

NCT06895304 | Not Yet Recruiting DMC

• 1 other identifier: 018
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue or warm-up and muscular strength in upper and lower limbs, in sedentary older adults, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, diaphragmatic ultrasonography, functionality and handgrip strength. According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue or activation in sedentary older adults could influence muscular strength, respiratory function and exercise capacity. In this study, subjects will be divided into three groups: the fatigue group , the activation group and the control group. Measurements of variables, such as maximal inspiratory pressure, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted.

Conditions

Sedentary; Healthy

Outcome Measures

Primary Outcomes (3)

• Respiratory muscle strength

  It will be assessed using a MicroRPM® (MicroMedical, UK). Maximum Inspiratory Pressure (MIP): The person will be instructed to take a maximal deep breath in, and then exhale to residual volume. After that, they will be asked to inhale forcefully against the resistance provided by the MicroRPM®. This measures the strength of the inspiratory muscles. The measures will be expressed in cmH2O.

  Immediately before intervention and immediately after intervention

• Diaphragmatic thickness and thickening fraction

  Diaphragmatic thickness and thickening fraction The linear array probe with a frequency of 3.0-10 megahertz (MHz) is placed perpendicularly to chest wall close to the mid-axillary line which is between the 8th and 10th intercostal space. The thickness of diaphragm is measured at the end of expiration and maximum inspiration for three times and the average values were recorded. The measures will be expressed in centimeters.

  Immediately before intervention and immediately after intervention

• Diaphragm movement curve

  The convex array probe with a frequency of 1.5-4.6 MHz is placed below the midclavicular line of the right costal margin in longitudinal scanning plane. The liver was used as an inspection window, and the probe was pointed toward the cephalic side. The ultrasound bundle is perpendicular to the posterior third of the right diaphragm. M-mode ultrasound is used to record the diaphragmatic movement curve during quiet breathing (QB) and deep breathing (DB). The measures will be expressed in milliseconds.

  Immediately before intervention and immediately after intervention

Secondary Outcomes (2)

• 6 minutes walking test

  Immediately before intervention and immediately after intervention

• Handgrip strength

  Immediately before intervention and immediately after intervention

Study Arms (3)

Inspiratory muscle fatigue group

EXPERIMENTAL

The EG (fatigue group) will perform the diaphragmatic fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their MIP (Maximum Inspiratory Pressure) through a threshold valve device. The participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts.

Device: inspiratory muscle training

Control group

NO INTERVENTION

they will not receive any intervention. Just sit and wait the same amount of time that the intervention and the activation group needs to finish their protocol (around 10 minutes)

Inspiratory muscle activation group

ACTIVE COMPARATOR

The activation group will perform the protocol of 2 sets of 30 repetitions at 15% of their MIP, one-on-one, and in a single session, breathing against submaximal inspiratory loads using a threshold valve device. The participants will follow a free pattern of breathing until complete the protocol.

Device: inspiratory muscle training

Interventions

inspiratory muscle training DEVICE

The subjects will perform deep inspirations against a threshold device with varying resistances to observe the effect on the diaphragm and the musculature of the upper limbs.

Also known as: Inspiratory muscle fatigue

Inspiratory muscle fatigue group

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Being over 60 years old.
• Physical independence in terms of gait and transfers
• Engaging in less than 150 minutes of physical activity per week.

You may not qualify if:

• Having any pathology that prevents the performance of physical activity.
• Subjects with impaired cognitive abilities.
• Subjects with tympanic perforation or middle-inner ear pathology.
• Subjects with chronic respiratory, cardiac, renal, or metabolic pathology..
• Subjects who have undergone lower limb surgery within the past 12 months.

Sponsors & Collaborators

• Sierra Varona SL: lead

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Arturo Ladriñan

CONTACT

925 26 88 00; arturo.ladrinan@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: March 31, 2025
• Primary Completion: April 3, 2025
• Study Completion: April 10, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03