AzTrials
AzTrials

In Brazil, Which Has an Increasing Number of Elderly People.Phase 2/3NCT01001156

Effects of the Breathing Muscular Training of Institutionalized Elderly

A Phase 2/3 study testing Comparison of different breathing muscular training in people with In Brazil, Which Has an Increasing Number of Elderly People. and The Physiological Alterations of Aging Are Systemic., run by Universidade Camilo Castelo Branco at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to use associated breathing exercises the incentive inspiratory of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in institutionalized elderly, comparing the effect of the same ones in the training of the breathing musculature, for the increment of the… Read more about this study

Who is it for?
Ages 60 to 82 years
What is being tested?
Comparison of different breathing muscular training
How many people
37 participants
Where
1 siteBrazil
Study dates
Oct 2008to May 2009
Phase
Phase 2/3
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 60 to 82 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The elderly individuals were required to be in good physical and cognitive condition to be considered for the study

Who cannot join

  • Eliminated participation by those who had acute-phase infections of the cardio-respiratory system and those who did not have a satisfactory cognitive level to understand the evaluation tests and the exercises performed in the treatment programs.
  • Also excluded were people who presented skeletal muscle and neurological sequel, presented metabolic syndromes or failed to adhere to the training program for more than one week.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Marilia de Andrade Fonseca

    Rio de Janeiro, Rio de Janeiro, 22780-160

Other trials in Brazil

About this study

Official title: Effects of the Breathing Muscular Training to Volume and the Pressure in MIP and MEP of Institutionalized Elderly

The purpose of this study was to use associated breathing exercises the incentive inspiratory of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in institutionalized elderly, comparing the effect of the same ones in the training of the breathing musculature, for the increment of the muscular strength, expressed by the maximum breathing pressures (MIP and MEP).

From the total number of admitted people (n = 52), 12 individuals were excluded: one by appearance of cognitive deficit, one by death (stroke), one by visual deficit (glaucoma) and twelve by failure to continue the training. After selecting the sample, the 37 participants were randomly divided into three different groups: the Threshold Group (TG; n = 13, age = 70. 93 ± 8.41 years old, BMI = 24.06 ± 3.69 kg/m²), the Voldyne Group (VG; n = 12, age = 70.54 ± 7. 73 years-old, BMI = 27.17 ± 5.66 kg/m²) and the Control Group (CG; n= 12, age = 73. 92 ± 7.28 years-old, BMI = 24.80 ± 5.42 kg/m²). The TG and VG received treatment with respiratory exercises and Threshold and Voldyne muscular training, respectively. The CG received only respiratory exercises.

Read the detailed description

The physiologic alterations of the aging are systemic and they seem to be more evident in the institutionalized elderly. The advanced age is associated to the decrease of the force of the skeletal muscles, as well as the one of the muscles respiratory. In the breathing system happen important muscle-skeletal alterations, interfering in the mechanics ventilatory. The changes in the compliance of the thoracic wall and of the lung stcruture resulting in imprisonment of air, air-trapping ", increasing the breathing work simultaneously the and functional residual capacity (FRC) with consequent decrease of the pressure maximum expiratory. Also the decreases of the pick of flow expiratory and changes in the curve flow-volume contributing to the closing of the outlying aerial roads. This way the breathing muscular function will be strongly harmed and correlated with the state nutritional and it forces muscular outlying. Besides, modifications in the curvature of the diaphragm, with a negative effect for the capacity to generate muscular force, collaborating for the decrease inspiratory.

The participant was completely evaluated, including personal information, medical history and a physical examination.

Measurement of Translation provided gratis.

MIP and MEP: Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively. This was measured using a device called a vacuum manometer (analogical with operational intervals of -120 to + 120 cmH2O, Critical Med/USA-2002 and display with scale intervals of 4 cmH2O). During MIP measurements, a nasal clip was used, which prevented air from escaping during the evaluation. In MIP measurements, the mouth and oropharynx can create negative pressure that can alter the results depending on whether the glottis opens (correct form) or closes (improper form). To prevent this interference of the orofacial musculature in the MIP measurements, an escape orifice was placed in the measurement instrument. This orifice relieved the pressure without significantly affecting the pressure produced by the respiratory muscles. Five tests were carried out to get three acceptable measures (i.e., duration of at least 2 seconds and an absence of emptying).

Acceptable tests were required to have at least two reproducible measurements (a maximum difference of 5% between the two maxima). A rest of at least one minute between tests was used for better equalization of the volumes and (consequently) the attainment of maximum pressures. To measure MEP, the patient was instructed to inhale until reaching total pulmonary capacity (TPC) and to carry through a supported expiratory effort down to the residual volume (RV). A seated position was used when measuring both MIP and MEP.

Threshold Group Training: after the measurement of the initial MIP and MEP (pre-training), the elderly individuals of the TG were submitted to a respiratory exercise program. The research of Ide et al. (2007) showed that this program contributes to an increase in chest expansion in healthy elderly people. The program was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements. After training, the Threshold® IMT (Respironics USA - 2004) was used. This device is commercially offered in the form of a transparent plastic cylinder; at one end is a valve that is kept closed for the positive pressure by a spring, while at the other end is a nipple. The valve blocks the aerial flow until the patient generates inspiratory pressure sufficient to overcome the spring.

The utilization of Threshold in this research began with a gradual load, starting with 50% of the MIP of each individual and increasing 10% per week until the fourth week. From the fifth week on, this was increased by 5% until 100% was reached in the eighth week or the maximum pressure value of the Threshold IMT (41 cmH2O) was reached. Thereafter, this value was kept constant in the final two weeks. The sessions lasted 20 minutes and consisted of seven series of strengthening (2 minutes each) with an interval of 1 minute between the series; sessions were conducted three times per week for ten weeks.

In the use of this training program, all the elderly individuals had been evaluated separately and trained in a group with individualized attention.

Voldyne Group Training: The same respiratory exercises used in the TG were used in the VG.

The maximum inspiratory sustentation technique (MIS) using the Voldyne mobilizes great pulmonary volumes and thereby increases the intra-alveolar pressure until the end of the supported inspiration. The increase in the intra-alveolar pressure is directly proportional to the contractile strength of the respiratory muscles (diaphragm and accessories), thus justifying the fact that intense muscular activity is required to reach the total pulmonary capacity (TPC) and to support inspiration at this level.

The use of EI (Voldyne®) incentive spirometry as muscular training in elderly people and as a basis for physiotherapy followed some guidelines. The patient's trunk was positioned at 30º relative to the horizontal plane, providing more diaphragmatic conscription. The device was positioned vertically. The volume indicator was visible to the patient to provide visual biofeedback. The patient was instructed to carry out a slow and deep inspiration until reaching TPC from the functional residual capacity (FRC). Slow inspiration favours a laminar flow. A sustentation of the maximum inspiration of around three seconds was recommended. Expiration occurred normally until the FRC was reached. During the use of Voldyne, patient hyperventilation was avoided. Intervals of 60 seconds between the inspiration support maxima were recommended 11. The elderly subjects received a verbal command to initiate a new inspiration. In this study, the Voldyne was used for 20 minutes, that is, 40 repetitions with 2 repetitions per minute. The procedure lasted 10 weeks at a frequency of three times per week. The group was supervised intermittently during the twenty minutes to ensure that hyperventilation was not occurring.

Control Group Training: This group received only respiratory exercises. The exercises was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements.

Statistical Treatment:The average and standard deviation (av ± sd) were calculated for age, body mass index, maximum respiratory pressure and functional autonomy. The normality of the sample was evaluated by the Shapiro-Wilk test and the homogeneity of the variance by the test of Levene. For the within-groups analysis variables, the parametric Student's t test or Wilcoxon was used when appropriate (for homogeneous or heterogeneous distribution of the data, respectively). For the between-groups evaluation, the nonparametric Kruskal-Wallis test was used followed by the Mann-Whitney multiple comparisons test. The statistical significance level adopted was p < 0.05. Excel and the SPSS v14.0 statistical package program were used to evaluate the data.

Being tested
Comparison of different breathing muscular training
Keywords
Aged, Breathing Muscles, Strength Muscles, Institution of long Permanence for elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comparison of different breathing muscular trainingOther

    Also called Aged, Breathing Muscles, Strength Muscles.

    Three times per week for ten weeks, thirty minutes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O

    Measured: One minute

Secondary outcomes (1)
  1. Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively.

    Measured: Ten weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionDec 2008
  4. Study completionMay 2009

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01001156
Sponsor's protocol ID
0043-2008
Status last verified
Oct 2009
First submitted
21 Oct 2009
Last updated
23 Oct 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Hill K, Jenkins SC, Philippe DL, Cecins N, Shepherd KL, Green DJ, Hillman DR, Eastwood PR. High-intensity inspiratory muscle training in COPD. Eur Respir J. 2006 Jun;27(6):1119-28. doi: 10.1183/09031936.06.00105205.

    PubMed 16772388

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Comparison of different breathing muscular training in people with In Brazil, Which Has an Increasing Number of Elderly People. and The Physiological Alterations of Aging Are Systemic., run by Universidade Camilo Castelo Branco at 1 site in Brazil.

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 1 inclusion and 2 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: finished, as of the sponsor's last update on 23 Oct 2009. 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 Brazil. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O (time frame: One minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01001156, which also lists 1 linked publication.

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 23 Oct 2009.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in