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

NCT04574934 | Unknown

• 1 other identifier: P.T.REC/012/002574
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscular Dystrophy

Keywords

Aquatic Therapy; pulmonary Functions; muscular dystrophy

Outcome Measures

Primary Outcomes (6)

• 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) will be assessed at day 0.

• 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) will be assessed at day 90.

• 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) will be assessed at day 0.

• 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) will be assessed at day 90.

• 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) will be assessed at day 0.

• 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) will be assessed at day 90.

Study Arms (2)

the study group

EXPERIMENTAL

study group received the traditional physical therapy program plus aquatic therapy

Other: aquatic therapy

the control group

NO INTERVENTION

control group received traditional physical therapy program only.

Interventions

aquatic therapy OTHER

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

the study group

Eligibility Criteria

• Age: 4 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (5)

• 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.

  PMID: 12467755 BACKGROUND

• 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.

  PMID: 21333078 BACKGROUND

• 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.

  PMID: 23836708 RESULT

• 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.

  PMID: 12409823 RESULT

• 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.

  PMID: 22938880 RESULT

MeSH Terms

Conditions

Muscular Dystrophies

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Nehad A. Abo-zaid, Ph.D

  South Valley University

  PRINCIPAL INVESTIGATOR

• Mohammed E. Ali, Ph.D student

  South Valley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: October 5, 2020
• Study Start: June 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)