Breathing Exercises With And Without Aerobic Training In Patients With Postural Orthostatic Tachycardia Syndrome

NCT ID: NCT05404672

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-01-15

Brief Summary

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Postural orthostatic tachycardia syndrome (POTS) is a chronic, multifactorial syndrome with complex symptoms of orthostatic intolerance. Of the major complaints are breathlessness and exercise intolerance. The aim is to explore the potential impact of a physiotherapy intervention involving education and breathing control on dysfunctional breathing and improving exercise intolerance in POTS. The study would be a randomised controlled trial. Duration would be 4 week. Patients will be randomly divided into two groups by lottery method. Data will be collected through questionnaire from enrolled subjects in physical therapy department of Liaqat Hospital, Lahore. Experimental group will be treated by Progressive Breathing Retraining Exercise Program-2 times a day for 15 minutes, initially Controlled Nasal Breathing with progressively increasing the Controlled Pause, 4 times a day for 15 minutes, then both techniques will be performed together. In addition to this Aerobic training will be assigned to both the groups. Aerobic training will include cycling and treadmill- for 30 minutes\\day for 5 days\\week for 1 month. Total 20 sessions. While the controlled group will receive only aerobic training which will include cycling and treadmill for 30 minutes\\day for 5 days\\week for 1 month. Total 20 sessions. The dysfunctional breathing and exercise intolerance will be assessed through Nijmegen Questionnaire and Veterans Questionnaire respectively at 0 week, after 2 week and after 4 week. The data will be analyzed by spss version 25.

Detailed Description

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Conditions

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Postural Orthostatic Tachycardia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Aerobic Training

Progressive breathing training exercises for a period of 4 weeks, for 15 minutes twice daily. As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced. 4 times a day followed by a sustained period of breathing control. In addition to this Aerobic Training (cycling, treadmill) will also be practiced for 30 minutes constituting 5 days/ week. Initial training would avoid upright position. Mild-to-moderate-intensity endurance training, progressing from semi-recumbent to upright position plus strength training will be practiced.

Group Type EXPERIMENTAL

Aerobic Training

Intervention Type OTHER

Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily. As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced. 4 times a day followed by a sustained period of breathing control. In addition to this Aerobic Training (cycling, treadmill) will also be practiced for 30 minutes constituting 5 days/ week. Initial training would avoid upright position. Mild-to-moderate-intensity endurance training, progressing from semi-recumbent to upright position plus strength training will be practiced.

Conventional Treatment

Intervention Type OTHER

Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily. As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced. 4 times a day followed by a sustained period of breathing control.

Conventional Treatment

Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily. As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced. 4 times a day followed by a sustained period of breathing control.

Group Type ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type OTHER

Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily. As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced. 4 times a day followed by a sustained period of breathing control.

Interventions

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Aerobic Training

Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily. As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced. 4 times a day followed by a sustained period of breathing control. In addition to this Aerobic Training (cycling, treadmill) will also be practiced for 30 minutes constituting 5 days/ week. Initial training would avoid upright position. Mild-to-moderate-intensity endurance training, progressing from semi-recumbent to upright position plus strength training will be practiced.

Intervention Type OTHER

Conventional Treatment

Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily. As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced. 4 times a day followed by a sustained period of breathing control.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Only Females
* Age: (15-45years)
* +ve tilt table test
* +ve 10 minutes standing test
* Nijmegen score \>22,
* increase in HR\>30bpm; with no orthostatic fall in blood pressure.symptoms occuring in \>3 months

Exclusion Criteria

* pregnancy
* No cardiac or respiratory pathology
* Surgical history
* Participants in another research protocol
* Any other medical condition that confers greater morbidly than POTs (e.g.,active Cancer)
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hafiza Muriam Ghani, MSPT-CP

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Liaqat Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Abed H, Ball PA, Wang LX. Diagnosis and management of postural orthostatic tachycardia syndrome: A brief review. J Geriatr Cardiol. 2012 Mar;9(1):61-7. doi: 10.3724/SP.J.1263.2012.00061.

Reference Type BACKGROUND
PMID: 22783324 (View on PubMed)

Reilly CC, Floyd SV, Lee K, Warwick G, James S, Gall N, Rafferty GF. Breathlessness and dysfunctional breathing in patients with postural orthostatic tachycardia syndrome (POTS): The impact of a physiotherapy intervention. Auton Neurosci. 2020 Jan;223:102601. doi: 10.1016/j.autneu.2019.102601. Epub 2019 Nov 12.

Reference Type BACKGROUND
PMID: 31743851 (View on PubMed)

Deb A, Morgenshtern K, Culbertson CJ, Wang LB, Hohler AD. A survey-based analysis of symptoms in patients with postural orthostatic tachycardia syndrome. Proc (Bayl Univ Med Cent). 2015 Apr;28(2):157-9. doi: 10.1080/08998280.2015.11929217.

Reference Type BACKGROUND
PMID: 25829642 (View on PubMed)

Jarosz B. POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS): ITS RELEVANCE, AND IMPORTANCE, IN THE MANAGEMENT OF SPORT RELATED CONCUSSION. Chiropractic Journal of Australia. 2021;48(1):31-4.

Reference Type BACKGROUND

Raj SR, Guzman JC, Harvey P, Richer L, Schondorf R, Seifer C, Thibodeau-Jarry N, Sheldon RS. Canadian Cardiovascular Society Position Statement on Postural Orthostatic Tachycardia Syndrome (POTS) and Related Disorders of Chronic Orthostatic Intolerance. Can J Cardiol. 2020 Mar;36(3):357-372. doi: 10.1016/j.cjca.2019.12.024.

Reference Type BACKGROUND
PMID: 32145864 (View on PubMed)

Dani M, Fedorowski A. Tackling POTS Needs More Than Just a Sympathetic Approach. Hypertension. 2024 Nov;81(11):2248-2250. doi: 10.1161/HYPERTENSIONAHA.124.23716. Epub 2024 Oct 16. No abstract available.

Reference Type DERIVED
PMID: 39413203 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/22/0320

Identifier Type: -

Identifier Source: org_study_id

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