Clinical trial NCT04574934: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Muscular Dystrophy
Keywords: Aquatic Therapy
pulmonary Functions
muscular dystrophy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Forced Vital Capacity (FVC) will be assessed at day 0.
measure: Forced Vital Capacity (FVC)
timeFrame: Forced Vital Capacity (FVC) will be assessed at day 90.
measure: Forced Expiratory Volume (FEV1)
timeFrame: Forced Expiratory Volume (FEV1) will be assessed at day 0.
measure: Forced Expiratory Volume (FEV1)
timeFrame: Forced Expiratory Volume (FEV1) will be assessed at day 90.
measure: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio)
timeFrame: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 0.
measure: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio)
timeFrame: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 90.
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
state: Qina
Study officials:
affiliation: South Valley University
name: Nehad A. Abo-zaid, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: South Valley University
name: Mohammed E. Ali, Ph.D student
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.