NCT05201742

Brief Summary

Patients suffering from parkinsonism have respiratory function abnormalities. This study compared the effects of incentive spirometer and inspiratory muscle trainer on pulmonary functions in patients with parkinsonism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

January 9, 2022

Last Update Submit

January 27, 2022

Conditions

Parkinson Disease

Keywords

Parkinson diseaseIncentive spirometerInspiratory muscle trainerPulmonary functions

Outcome Measures

Primary Outcomes (5)

  • Maximum inspiratory pressure (MIP)

    Maximum inspiratory pressure was measured.

    6 weeks

  • 6-minute walk distance (6 MWD)

    Distance walked by the patients in 6 minutes was measured.

    6 weeks

  • Forced vital capacity (FVC)

    Forced vital capacity was measured.

    6 weeks

  • Forced expiratory volume in 1 second (FEV1)

    Forced expiratory volume in 1 second was measured

    6 weeks

  • Peak Expiratory Flow Rate (PEFR)

    Peak Expiratory Flow Rate was measured

    6 weeks

Study Arms (2)

Inspiratory muscle trainer

ACTIVE COMPARATOR

Inspiratory muscle trainer group - Inspiratory muscle training was performed.

Other: Inspiratory muscle training

Incentive spirometer

ACTIVE COMPARATOR

Incentive spirometer group - Incentive spirometry was performed.

Other: Incentive Spirometry

Interventions

Inspiratory muscle trainingOTHER

Threshold inspiratory muscle training was performed for 6 weeks with device.

Inspiratory muscle trainer
Incentive SpirometryOTHER

Incentive spirometry was performed for 6 weeks with device.

Incentive spirometer

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients diagnosed as having Parkinsonism Disease by the Neuro physician.
  • Duration of Parkinson's Disease ≥ 5 years.
  • Patients with the age of 65 to 80 years.
  • Hoen and Yahr classification within 1 to 3.
  • Both males and females were included.
  • Patients who were able to comprehend the commands.
  • Patients who were willing to participate.

You may not qualify if:

  • Patients having any cardiovascular and pulmonary disorders.
  • History of smoking currently or in the past.
  • Psychological Impairment.
  • Insufficient verbal/intellectual understanding.
  • Patients with unstable vital parameters.
  • Those unable to perform pulmonary function tests (PFT) because of anatomical abnormalities or clinical signs of dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Masood Khan, M.P.Th

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 21, 2022

Study Start

February 6, 2017

Primary Completion

January 18, 2018

Study Completion

May 10, 2018

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)