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

Sponsor

South Valley University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04574934

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Muscular Dystrophy	Other: aquatic therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (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).

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Valley University, Faculty of Physical Therapy	Qinā	Qina	Egypt	83523

Sponsors and Collaborators

South Valley University

Investigators

Principal Investigator: Nehad A. Abo-zaid, Ph.D, South Valley University
Principal Investigator: Mohammed E. Ali, Ph.D student, South Valley University

Study Documents (Full-Text)

Study Protocol - Sep 26, 2020

More Information

Publications

Responsible Party:

Mohammed E. Ali, Ph. D Candidate., Principal Investigator, South Valley University

ClinicalTrials.gov Identifier:

NCT04574934

Other Study ID Numbers:

P.T.REC/012/002574

First Posted:

Oct 5, 2020

Last Update Posted:

Oct 5, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohammed E. Ali, Ph. D Candidate., Principal Investigator, South Valley University

Aquatic Therapy

pulmonary Functions

muscular dystrophy

Additional relevant MeSH terms:

Muscular Dystrophies

Study Results

No Results Posted as of Oct 5, 2020