Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability

S

Sierra Varona SL

Status

Not yet enrolling

Conditions

Healthy

Treatments

Other: Inspiratory muscle training

Study type

Interventional

Funder types

Other

Identifiers

NCT06269042
0010

Details and patient eligibility

About

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 and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability. According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function. In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group. Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted.

Full description

This is a randomized control trial. The experimental group (EG) 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 Maximum Inspiratory Pressure (MIP) 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. The activation group (AG) will perform the protocol of 2 sets of 30 repetitions at 15% of their MIP, one-on-one, and in a single session, using a threshold valve device. The control group will do a seat and wait. The interventions will be supervised by a physiotherapist. The primary outcomes will be Respiratory muscle strength will be assessed using a respiratory pressure meter or manometer designed, and with ultrasound image measuring the cross sectional area of the diaphragm at 8-9th rib level and speed of contraction with a deep and fast inspiratory manoeuver. This will be done immediately before intervention and immediately after intervention Heart rate variability (HRV) will be assessed using a heart rate sensor Polar H10.

Enrollment

18 estimated patients

Sex

All

Ages

60 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Being over 60 years old.
  • Physical independence in terms of gait and transfers.

Exclusion criteria

  • 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 pulmonary hypertension, decompensated heart or respiratory failure.
  • Subjects who have undergone lower limb surgery within the past 12 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

18 participants in 3 patient groups

Intervention group
Experimental group
Description:
The EG (experimental 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.
Treatment:
Other: Inspiratory muscle training
Control group
No Intervention group
Description:
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)
Activation group
Active Comparator group
Description:
The activation group will perform the protocol of 2 sets of 30 repetitions at 40% 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.
Treatment:
Other: Inspiratory muscle training

Trial contacts and locations

0

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Central trial contact

eva V sanz; SIerra V SL

Data sourced from clinicaltrials.gov

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