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Evaluation of the effects of Respiratory Training in patients with Sickle Cell Disease

Evaluation of the effects of Inspiratory Muscle Training in patients Sickle Cell Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6g8n92
Enrollment
Unknown
Registered
2020-04-22
Start date
2019-04-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle-cell disorders

Interventions

The intervention consisted of inspiratory muscle training (IMT) that was applied both in the group undergoing training with false load (SG) and in the other group was called intervention group (TG), w
the 6-minute walk test (6MWT) was performed with blood lactate concentration (Lac) assessment, using a lactimeter pre and post 6MWT. IMT was performed at the patients home through the inspiratory moti
Device
C15.378.071.141.150.150.440
E01.370.386.700.150

Sponsors

Hemocentro - Universidade Estadual de Campinas
Lead Sponsor
Hemocentro - Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Have a diagnosis of sickle cell disease; of both genders; be between 18 and 70 years old; present a stable clinical condition of the disease.

Exclusion criteria

Exclusion criteria: Present neurological or traumatic sequelae that make it impossible to properly perform any of the assessment items; presenting neurological or traumatic sequelae that make it impossible to properly perform inspiratory muscle training; present any lung disease that is not related to sickle cell disease and that may alter the appropriate performance of any of the assessment items.

Design outcomes

Primary

MeasureTime frame
Expected result 1: Increase in inspiratory and expiratory muscle forces in the intervention group with real load (TG) compared to the group that performed the training with false load (SG) after the intervention period.;Outcome found 1: Statistically significant increase (p <0.05) of inspiratory and expiratory muscle forces in the comparison between the initial and the final evaluation, both in the intervention group with real load (TG) and in the group that performed the training with false load (SG).;Expected outcome 2: Improvement of the variables evaluated in spirometry in the intervention group with real load (TG) in relation to the group that performed the training with false load (SG) after the intervention period.;Outcome found 2: Statistically significant increase (p <0.05) of the spirometric variables forced expiratory flow in the first second, Tiffeneau index and average forced expiratory flow in the comparison between pre and post bronchodilator evaluation, both in the initial evaluation and in the final evaluation in both groups, but no significant changes were observed in the comparison between the initial and final evaluations.;Expected outcome 3: Improvement of the variables assessed in the volumetric capnography in the intervention group with real load (TG) compared to the group that performed the training with false load (SG) after the intervention period.;Outcome found 3: Of the variables assessed in volumetric capnography, the inspiratory time (Ti) was significantly longer in the group that performed the training with false load (SG) compared to the intervention group with real load (TG) (p <0.05, group effect). However, the following variables: inspiratory tidal volume (Vi), peak expiratory flow (PEF), phase 3 slope of the capnography curve (P3Slp), phase 3 slope normalized according to expired tidal volume (P3Slp / Ve ), peak inspiratory flow (PIF) and Tobin Index (RSBI) showed significant changes in relation to the effect of time in both group

Secondary

MeasureTime frame
Expected outcome 1: Secondary outcomes were not expected in relation to inspiratory and expiratory muscle forces.;Outcome found 1: The group that performed the training with false load (SG) also obtained a statistically significant increase (p 0.05 in all variables when comparing the pre-intervention period with the post-intervention period in the intervention group with real load (TG).;Expected outcome 3: Secondary outcomes were not expected in relation to the variables assessed in volumetric capnography.;Outcome found 3: The group that performed the training with false load (SG) had a statistically significant longer inspiratory time (Ti) (p 0.05.;Expected outcome 6: No secondary outcome was expected in relation to the limitation imposed by dyspnea on activities of daily living after the intervention period.;Outcome found 6: The group that performed training with false load (SG) showed a significant reduction (p 0.05.

Countries

Brazil

Contacts

Public ContactSara Saad

Hemocentro - Universidade Estadual de Campinas

sara@unicamp.br+551935218383

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 17, 2026