Parkinson DiseaseNCT03977740
Chest PNF on Pulmonary Function in Parkinson Disease
A study testing chest PNF and Conventional in people with Parkinson Disease, run by Subhasish Chatterjee at 1 site in India.
Trial summary
Background: Parkinson disease (PD) is a progressive neurodegenerative disorder and characterized by tremor, rigidity and bradykinesia. Almost 84% of PD patient develops respiratory abnormalities and pointed as the most common cause of death. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- chest PNF and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2018to 10 Jun 2019
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
- MMSE score >23.
- Age 50-70 yrs.
- Both Male and Female.
Who cannot join
- Previous history of cardiac and pulmonary surgery.
- History of flail chest.
- Individual affected by neurological disorder other than PD.
- Uncooperative patients.
- Individual with the psychosomatic disorder.
Trial locations and contacts
1 site in 1 country.
Nidhi Sharma contact
India1 site, 1 recruiting
- Recruiting
MMIPR
Ambāla, Haryana, 133207
Mousumi Saha, MPT, msaha0029@gmail.com
About this study
Official title: Efficacy of Chest PNF on Pulmonary Function in Patients With Parkinson's Diseases
Background: Parkinson disease (PD) is a progressive neurodegenerative disorder and characterized by tremor, rigidity and bradykinesia. Almost 84% of PD patient develops respiratory abnormalities and pointed as the most common cause of death. Airway obstruction, trunk muscle rigidity is the common cause of respiratory abnormalities.
Purpose: The main purpose of the study will evaluate the efficacy of chest PNF on pulmonary function and chest wall mobility in PD.
Methods: 20 participants will be recruited for study purpose and divide into two groups. Group= A will be the control group and participants will receive conventional treatment which includes deep breathing exercise and segmental breathing exercise, incentive spirometry etc for one week. Group= B participants will receive chest PNF exercise along with conventional treatment for a week. Pretreatment and post-treatment data will be recorded by the help of PFT (FVC, FEV1 \& FEV1/FVC) and chest wall expansion at axillary and xiphisternal level for data analysis. Data analysis will be done by paired t-test for within group and independent t-test will be used for the between-group variable. The level of significance will be set at 0.05.
- Conditions
- Parkinson Disease
- Being tested
- chest PNF, Conventional
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest PNFOther
Chest PNF technique includes oblique downward pressure at sternum, diagonal pressure at lower rib cage at supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on elbow.
ConventionalOther
conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
| Study group | Role | What they receive |
|---|---|---|
| chest PNF | Experimental | participants received conventional chest physiotherapy along with chest PNF technique 5 days for 1 week.
Chest PNF technique includes oblique downward pressure at the sternum, diagonal pressure at lower rib cage at the supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on the elbow. Receives: Other: chest PNF |
| Conventional | Active comparator | participants received conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test (PFT)
Pulmonary functions parameters FVC in litre, FEV1 in litre and ratio between FVC/FEV1 will be recorded with PFT
Measured: changes bwtween baseline to 1 week
Secondary outcomes (1)
chest wall expansion by inch tape
chest wall expansion will be measured at axillary and xiphisternal level
Measured: changes bwtween baseline to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jan 2018
- Primary completion10 Jun 2019 (estimated)
- Study completion10 Jun 2019 (estimated)
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Subhasish Chatterjee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977740
- Sponsor's protocol ID
- IEC-1111
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chest PNF on Pulmonary Function in Patients With Parkinson's Diseases
- ClinicalTrials.gov ID
- NCT03977740
- Acronym / sponsor ID
- IEC-1111
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Subhasish ChatterjeeUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 10 Jun 2019 (estimated)
- Study completion
- 10 Jun 2019 (estimated)
- First posted
- 6 Jun 2019 (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.
Background: Parkinson disease (PD) is a progressive neurodegenerative disorder and characterized by tremor, rigidity and bradykinesia. Almost 84% of PD patient develops respiratory abnormalities and pointed as the most common cause of death. Airway obstruction, trunk muscle rigidity is the common cause of respiratory abnormalities.
Purpose: The main purpose of the study will evaluate the efficacy of chest PNF on pulmonary function and chest wall mobility in PD.
Methods: 20 participants will be recruited for study purpose and divide into two groups. Group= A will be the control group and participants will receive conventional treatment which includes deep breathing exercise and segmental breathing exercise, incentive spirometry etc for one week. Group= B participants will receive chest PNF exercise along with conventional treatment for a week. Pretreatment and post-treatment data will be recorded by the help of PFT (FVC, FEV1 \& FEV1/FVC) and chest wall expansion at axillary and xiphisternal level for data analysis. Data analysis will be done by paired t-test for within group and independent t-test will be used for the between-group variable. The level of significance will be set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chest PNF | Experimental | Other: chest PNFparticipants received conventional chest physiotherapy along with chest PNF technique 5 days for 1 week. Chest PNF technique includes oblique downward pressure at the sternum, diagonal pressure at lower rib cage at the supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on the elbow. |
| Conventional | Active comparator | Other: Conventionalparticipants received conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
- MMSE score >23.
- Age 50-70 yrs.
- Both Male and Female.
Key exclusion criteria (5 listed)
- Previous history of cardiac and pulmonary surgery.
- History of flail chest.
- Individual affected by neurological disorder other than PD.
- Uncooperative patients.
- Individual with the psychosomatic disorder.
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 |
|---|---|---|
| chest PNFChest PNF technique includes oblique downward pressure at sternum, diagonal pressure at lower rib cage at supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on elbow. | Other | chest PNF |
| Conventionalconventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer | Other | Conventional |
Primary outcome
Pulmonary Function Test (PFT)
Time frame: changes bwtween baseline to 1 week
Pulmonary functions parameters FVC in litre, FEV1 in litre and ratio between FVC/FEV1 will be recorded with PFT
1 secondary outcome
chest wall expansion by inch tape
Time frame: changes bwtween baseline to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Nidhi Sharma contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest PNF and Conventional in people with Parkinson Disease, run by Subhasish Chatterjee at 1 site in India.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2019. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mousumi Saha, MPT (9366787310, msaha0029@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (PFT) (time frame: changes bwtween baseline to 1 week). 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 6 Jun 2019.