NCT06326801

Brief Summary

To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

January 18, 2024

Last Update Submit

March 17, 2024

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (3)

  • pulmonary function

    The pulmonary functions Spirometer measure can be expressed as Forced Expiratory Volume in 1 second (FEV1) and Force Vital Capacity (FVC) .

    4 weeks

  • Trunk Control

    Trunk performance and coordination by static and dynamic sitting balance was measured by TIS.TIS comprises 17 items, measures dynamic and static sitting balance and trunk co-ordination. The TIS total score is 0-23 points, higher scores show better performance. It takes about 6 to 16 minutes in applying TIS

    4weeks

  • Functional Capacity

    6 MWT is used for functional capacity of participants, by walking for 6 minutes. Participant walk between the point marked, as numerous periods as can in 6 minutes. The 6-minute walk (6mw) test is a reliable and valid measure of for assessing functional capacity.

    4weeks

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

1. Resistive Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy

Other: Resistive Diaphragmatic breathing exerciseOther: Diaphragmatic breathing exerciseOther: Conventional stroke physiotherapy

Treatment B

ACTIVE COMPARATOR

1. Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy

Other: Resistive Diaphragmatic breathing exerciseOther: Diaphragmatic breathing exerciseOther: Conventional stroke physiotherapy

Control group

ACTIVE COMPARATOR

a) Conventional stroke physiotherapy

Other: Resistive Diaphragmatic breathing exerciseOther: Diaphragmatic breathing exerciseOther: Conventional stroke physiotherapy

Interventions

Resistive Diaphragmatic breathing exerciseOTHER

1. Resistive Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy

Control groupTreatment ATreatment B
Diaphragmatic breathing exerciseOTHER

1. Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy

Control groupTreatment ATreatment B
Conventional stroke physiotherapyOTHER

Conventional stroke physiotherapy

Control groupTreatment ATreatment B

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-65 years
  • Onset of ischemic stroke in first two week
  • First episode of unilateral stroke with hemiparesis during previous 12 months
  • Patient with no serious cognitive deficits i-e mini-mental state examination (score \>22) ability to understand, perform and follow simple verbal instructions
  • Functional ambulation category (FAC) \>3
  • min walk test distance should be \>200 m

You may not qualify if:

  • Known case of cardiopulmonary disease, BP \> 180/100 mmHg twice in 24 hours
  • Known case of neurological disease other than stroke, Known case of orthopedic disease i-e funnel chest, rib fractures or any other orthopedic deformity
  • Medication that would influence metabolic or cardiorespiratory responses to exercise Impaired level of consciousness, Evidence of gross cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest General Hospital, Peshawar;

Peshawar, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Maria Razzaq, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

March 22, 2024

Study Start

September 1, 2023

Primary Completion

January 15, 2024

Study Completion

January 18, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)