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

Primary Purpose

Muscular Dystrophy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aquatic therapy
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophy focused on measuring Aquatic Therapy, pulmonary Functions, muscular dystrophy

Eligibility Criteria

4 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Valley University, Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the study group

the control group

Arm Description

study group received the traditional physical therapy program plus aquatic therapy

control group received traditional physical therapy program only.

Outcomes

Primary Outcome Measures

Forced Vital Capacity (FVC)
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)
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 Expiratory Volume (FEV1)
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)
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/Forced Vital Capacity Ratio (FEV1/FVC ratio)
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)
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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2020
Last Updated
September 28, 2020
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04574934
Brief Title
Effect of Aquatic Therapy on Pulmonary Functions in Patients With Muscular Dystrophy
Official Title
Effect of Aquatic Therapy on Pulmonary Functions in Patients With Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to assess the efficacy of aquatic therapy on pulmonary functions in patients with muscular dystrophy.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophy
Keywords
Aquatic Therapy, pulmonary Functions, muscular dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Thirty patients with muscular dystrophy were enrolled in this study and were assessed for eligibility. Their age ranged from four and forty years. They were assigned randomly into two equal groups. Group (A) study group received the traditional physical therapy program plus aquatic therapy. And the group (B) control group received traditional physical therapy program only. All patients will receive sessions two times/week for three successive months. Pulmonary function test was used to assess pulmonary functions pre and post-intervention. All patients were assisted before and after three months of intervention.
Masking
Outcomes Assessor
Masking Description
Blinding process to participants and care providers was impossible because of intervention therapy. We analyzed data by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (study group) and Group B (control group).
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the study group
Arm Type
Experimental
Arm Description
study group received the traditional physical therapy program plus aquatic therapy
Arm Title
the control group
Arm Type
No Intervention
Arm Description
control group received traditional physical therapy program only.
Intervention Type
Other
Intervention Name(s)
aquatic therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
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.
Time Frame
Forced Vital Capacity (FVC) will be assessed at day 0.
Title
Forced Vital Capacity (FVC)
Description
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.
Time Frame
Forced Vital Capacity (FVC) will be assessed at day 90.
Title
Forced Expiratory Volume (FEV1)
Description
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.
Time Frame
Forced Expiratory Volume (FEV1) will be assessed at day 0.
Title
Forced Expiratory Volume (FEV1)
Description
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.
Time Frame
Forced Expiratory Volume (FEV1) will be assessed at day 90.
Title
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio)
Description
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.
Time Frame
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 0.
Title
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio)
Description
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.
Time Frame
Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 90.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A. Abo-zaid, Ph.D
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed E. Ali, Ph.D student
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qinā
State/Province
Qina
ZIP/Postal Code
83523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12467755
Citation
Eagle M. Report on the muscular dystrophy campaign workshop: exercise in neuromuscular diseases Newcastle, January 2002. Neuromuscul Disord. 2002 Dec;12(10):975-83. doi: 10.1016/s0960-8966(02)00136-0. No abstract available.
Results Reference
background
PubMed Identifier
21333078
Citation
Bach JR, Martinez D. Duchenne muscular dystrophy: continuous noninvasive ventilatory support prolongs survival. Respir Care. 2011 Jun;56(6):744-50. doi: 10.4187/respcare.00831. Epub 2011 Feb 11.
Results Reference
background
PubMed Identifier
23836708
Citation
Khirani S, Ramirez A, Aubertin G, Boule M, Chemouny C, Forin V, Fauroux B. Respiratory muscle decline in Duchenne muscular dystrophy. Pediatr Pulmonol. 2014 May;49(5):473-81. doi: 10.1002/ppul.22847. Epub 2013 Jul 8.
Results Reference
result
PubMed Identifier
12409823
Citation
Fowler WM Jr. Role of physical activity and exercise training in neuromuscular diseases. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S187-95. doi: 10.1097/01.PHM.0000029726.80774.83.
Results Reference
result
PubMed Identifier
22938880
Citation
Abresch RT, Carter GT, Han JJ, McDonald CM. Exercise in neuromuscular diseases. Phys Med Rehabil Clin N Am. 2012 Aug;23(3):653-73. doi: 10.1016/j.pmr.2012.06.001.
Results Reference
result

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

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