Parkinson DiseaseNCT05201742
Incentive Spirometer and Inspiratory Muscle Trainer
A study testing Inspiratory muscle training and Incentive Spirometry in people with Parkinson Disease, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Inspiratory muscle training and Incentive Spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Feb 2017to 10 May 2018
- Phase
- Interventional
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Incentive Spirometer Versus Inspiratory Muscle Trainer on Pulmonary Function in Patients With Parkinsonism
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.
Read the detailed description
The participants were recruited according to the inclusion and exclusion criteria. Participants were divided into two groups - incentive spirometer and inspiratory muscle trainer. These trainings were performed for 6 weeks duration. Several outcome measures related to pulmonary function tests were measured before and after the intervention.
- Conditions
- Parkinson Disease
- Being tested
- Inspiratory muscle training, Incentive Spirometry
- Keywords
- Parkinson disease, Incentive spirometer, Inspiratory muscle trainer, Pulmonary functions
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Threshold inspiratory muscle training was performed for 6 weeks with device.
Incentive SpirometryOther
Incentive spirometry was performed for 6 weeks with device.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle trainer | Active comparator | Inspiratory muscle trainer group - Inspiratory muscle training was performed. Receives: Other: Inspiratory muscle training |
| Incentive spirometer | Active comparator | Incentive spirometer group - Incentive spirometry was performed. Receives: Other: Incentive Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure (MIP)
Maximum inspiratory pressure was measured.
Measured: 6 weeks
6-minute walk distance (6 MWD)
Distance walked by the patients in 6 minutes was measured.
Measured: 6 weeks
Forced vital capacity (FVC)
Forced vital capacity was measured.
Measured: 6 weeks
Forced expiratory volume in 1 second (FEV1)
Forced expiratory volume in 1 second was measured
Measured: 6 weeks
Peak Expiratory Flow Rate (PEFR)
Peak Expiratory Flow Rate was measured
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start6 Feb 2017
- Primary completion18 Jan 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201742
- Sponsor's protocol ID
- GSITESC/24/16
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Incentive Spirometer Versus Inspiratory Muscle Trainer on Pulmonary Function in Patients With Parkinsonism
- ClinicalTrials.gov ID
- NCT05201742
- Acronym / sponsor ID
- GSITESC/24/16
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Incentive spirometer, Inspiratory muscle trainer, Pulmonary functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The participants were recruited according to the inclusion and exclusion criteria. Participants were divided into two groups - incentive spirometer and inspiratory muscle trainer. These trainings were performed for 6 weeks duration. Several outcome measures related to pulmonary function tests were measured before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle trainer | Active comparator | Other: Inspiratory muscle trainingInspiratory muscle trainer group - Inspiratory muscle training was performed. |
| Incentive spirometer | Active comparator | Other: Incentive SpirometryIncentive spirometer group - Incentive spirometry was performed. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingThreshold inspiratory muscle training was performed for 6 weeks with device. | Other | Inspiratory muscle trainer |
| Incentive SpirometryIncentive spirometry was performed for 6 weeks with device. | Other | Incentive spirometer |
Primary outcome
Maximum inspiratory pressure (MIP)
Time frame: 6 weeks
Maximum inspiratory pressure was measured.
6-minute walk distance (6 MWD)
Time frame: 6 weeks
Distance walked by the patients in 6 minutes was measured.
Forced vital capacity (FVC)
Time frame: 6 weeks
Forced vital capacity was measured.
Forced expiratory volume in 1 second (FEV1)
Time frame: 6 weeks
Forced expiratory volume in 1 second was measured
Peak Expiratory Flow Rate (PEFR)
Time frame: 6 weeks
Peak Expiratory Flow Rate was measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Parkinson's Disease
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masood Khan, M.P.Th principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Incentive Spirometry in people with Parkinson Disease, run by King Saud University at 1 site in Saudi Arabia.
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 7 inclusion and 6 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 10 Feb 2022. 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 Saudi Arabia. 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.
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) (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2022.