Effect of Aquatic Therapy on Pulmonary Functions in Patients With Muscular Dystrophy

September 28, 2020 updated by: Mohammed E. Ali, Ph. D Candidate., South Valley University
This study aimed to assess the efficacy of aquatic therapy on pulmonary functions in patients with muscular dystrophy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening and breakdown of skeletal muscles over time. The disorders differ in which muscles are primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin. Many people will eventually become unable to walk. Some types are also associated with problems in other organs. The muscular dystrophy group contains thirty different genetic disorders that are usually classified into nine main categories or types.

The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting, poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk, waddling gait, Calf deformation, Limited range of movement,respiratory difficulty, cardiomyopathy and muscle spasms

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qina
      • Qinā, Qina, Egypt, 83523
        • South Valley University, Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Their age will ranging from four to forty years.
  • Patients participated in this study will from both sexes.
  • All patients will able to walk supported or unsupported by the therapist.
  • All patients will able to follow the instructions during testing and training.
  • All patients had no fixed contractures or deformities at the lower limb.

Exclusion Criteria:

  • Patients with visual or auditory problems.
  • Patients with structural joints deformities of the lower limbs.
  • Patients with convulsions and fixed contractures.
  • Uncooperative Patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the study group
study group received the traditional physical therapy program plus aquatic therapy
Other: aquatic therapy
Aquatic therapy refers to water-based treatments or exercises of therapeutic intent, in particular for relaxation, fitness, and physical rehabilitation. Treatments and exercises are performed while floating, partially submerged, or fully submerged in water. Many aquatic therapy procedures require constant attendance by a trained therapist and are performed in a specialized temperature-controlled pool. Rehabilitation commonly focuses on improving the physical function associated with illness, injury, or disability
No Intervention: the control group
control group received traditional physical therapy program only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: Forced Vital Capacity (FVC) will be assessed at day 0.
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Forced Vital Capacity (FVC) will be assessed at day 0.
Forced Vital Capacity (FVC)
Time Frame: Forced Vital Capacity (FVC) will be assessed at day 90.
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Forced Vital Capacity (FVC) will be assessed at day 90.
Forced Expiratory Volume (FEV1)
Time Frame: Forced Expiratory Volume (FEV1) will be assessed at day 0.
Forced expiratory volume in one second (FEV1) is a measurement of your ability to expel air from your lungs. More specifically, and as its name suggests, it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.
Forced Expiratory Volume (FEV1) will be assessed at day 0.
Forced Expiratory Volume (FEV1)
Time Frame: Forced Expiratory Volume (FEV1) will be assessed at day 90.
Forced expiratory volume in one second (FEV1) is a measurement of your ability to expel air from your lungs. More specifically, and as its name suggests, it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.
Forced Expiratory Volume (FEV1) will be assessed at day 90.
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio)
Time Frame: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 0.
is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease.[2][3] It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).[4] The result of this ratio is expressed as FEV1%. Normal values are approximately 75%.[5] Predicted normal values can be calculated online and depend on age, sex, height, and ethnicity as well as the research study that they are based upon. A derived value of FEV1% is FEV1% predicted, which is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex, and body composition.
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 0.
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio)
Time Frame: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 90.
is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease.[2][3] It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).[4] The result of this ratio is expressed as FEV1%. Normal values are approximately 75%.[5] Predicted normal values can be calculated online and depend on age, sex, height, and ethnicity as well as the research study that they are based upon. A derived value of FEV1% is FEV1% predicted, which is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex, and body composition.
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/002574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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