ClinicalTrials.gg
Status unknownNCT03417908Updated Nov 26, 2018

Respiratory Muscle Stretching Effect on Functional and Electromyographic Parameters of Patients With and Without COPD

An interventional study of PNF and Sham in COPD, sponsored by Universidade Federal do Pampa. Status unknown at 1 site in Brazil. Open to male participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-26.

Sponsored by Universidade Federal do Pampa · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Active, not recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 144 studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil — 20 open to participants now, 24 under way, 7 of them phase 3. Pulmonary Disease, Chronic Obstructive · Brazil.

Enrollment
57th of 124
60 · median 59
Started
2017
with 8 others
No phase
64 of 144
6 open now
Registered
92nd of 144
by date

Among the 144 studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil, this one is the 57th largest by enrollment of the 124 interventional ones that give a count, is one of 9 that started in 2017, is one of 64 with no phase, and was the 92nd registered.

Pulmonary Disease, Chronic Obstructive

5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

20 of the 144 studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil are open now. Recruiting first, the newest first:

15 more — sign in →

All 20 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.

This study: 40 Years and older · male · healthy volunteers too.

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02

Study summary

To evaluate the activation of accessory respiratory muscles and the effects of stretching these muscles in patients with COPD.

Read the detailed description

All subjects (sixty men) will perform spirometry, measure of inspiratory capacity (IC) and maximal inspiratory and expiratory pressures (MIP and MEP). Baseline blood pressure (BP), respiratory rate (RR), heart rate (HR), sensation of dyspnea (Borg Scale) and oxygen saturation (pulse oximetry, SpO2) will be collected prior to the performance of pulmonary function tests.

The electrical activity of the scalene (ESC), sternocleidomastoid (SCM) and external intercostal muscles (INTER) will be measured by surface electromyography (sEMG) at rest and during the maneuvers of IC, MIP and MEP.

Control group: The control group will perform isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.

Intervention group: The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) is maintained for 6 seconds. After that, the patient will be asked to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.

Statistical analysis will be carried out with the Statistical Package for the Social Sciences, version 18.0 (SPSS Inc., Chicago, IL, USA). Normality of data distribution will be assessed by the Shapiro-Wilk test.

Values will be presented as mean ± standard deviation (SD) or median (25-75%). To compare the differences between the baseline characteristics between the groups the t test for independent samples will be used. The effect of the intervention will be evaluated by paired t test. For the analysis of the electromyographic signal will be use the Wilcoxon T test. Statistical significance is accepted at p \< 0.05.

03

Conditions studied

  • COPD

Keywords

  • Proprioceptive neuromuscular facilitation
  • Pulmonary Rehabilitation
  • muscle activation
  • COPD
04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Control group: Men without respiratory symptoms and lung disease, with normal spirometry.
  • Interventional group: Men diagnosed with severe to very severe ( / forced vital capacity - FEV1/FVC \<0.7 and FEV1 \<50% predicted after bronchodilator use); clinically stable over the past 4 weeks.

Exclusion criteria

Exclusion Criteria:

  • History of fracture in the spine and / or upper limb
  • Herniated disc
  • Connective tissue disease
  • Ischemic heart disease or uncontrolled hypertension
  • Obesity (> 30 kg/m2)
  • Aortic aneurysm
  • Recent abdominal or thoracic surgery
  • Glaucoma
  • Retinal detachment
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    COPD - PNF

    COPD - PNF

    Procedure: PNF

  • Sham comparator
    COPD - sham

    COPD - sham

    Procedure: Sham

  • Active comparator
    Individuals Without COPD - PNF

    Individuals Without COPD - PNF

    Procedure: PNF

  • Sham comparator
    Individuals Without COPD - sham

    Individuals Without COPD - sham

    Procedure: Sham

Interventions

  • ProcedurePNF

    The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) will be maintained for 6 seconds. After that, the patient is oriented to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.

  • ProcedureSham

    Isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.

06

What researchers measure

Primary outcomes

  1. Change in inspiratory capacity

    Change in inspiratory capacity

    Time frame: One day

Secondary outcomes

  1. Change in maximal respiratory pressure (MIP and MEP)

    Change in maximal respiratory pressure (MIP and MEP)

    Time frame: One day

  2. Change in electromyographic activity of accessory respiratory muscles

    Change in electromyographic activity of accessory respiratory muscles

    Time frame: One Day

07

Study locations

1 site
  • Anelise Dumke
    Uruguaiana, Rio Grande Do Sul 97502-765, Brazil
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Dec 2018, 12 months after the start.

Of 1,095 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 12 months is below that.

Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2018
First posted
Jan 31, 2018
StartActual
Dec 4, 2017
Primary completionEst.
Dec 14, 2018
CompletionEst.
Dec 14, 2018
Last update
Nov 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03417908
Lead sponsor
Universidade Federal do Pampa
Responsible party
Anelise Dumke (Professor, Universidade Federal do Pampa) — Principal investigator
First posted
Jan 31, 2018
Start date
Dec 4, 2017
Primary completion
Dec 14, 2018 (estimated)
Completion
Dec 14, 2018 (estimated)
Last update
Nov 26, 2018

Study contacts

Anelise Dumke
principal investigator · Federal University of Rio Grande do Sul
Marli M. Knorst
study director · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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