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Muscular DystrophyNCT04574934

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

A study testing aquatic therapy in people with Muscular Dystrophy, run by South Valley University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 4 to 40 years
Conditions the study is for
Muscular Dystrophy
What is being tested?
aquatic therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Jun 2020to 1 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • South Valley University, Faculty of Physical Therapy

    Qina, Qena Governorate, 83523

Other trials in Egypt

About this study

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

Read the 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

Being tested
aquatic therapy
Keywords
Aquatic Therapy, pulmonary Functions, muscular dystrophy
Medical subject headings
Muscular Dystrophies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aquatic therapyOther

    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

Study groups in NCT04574934
Study groupRoleWhat they receive
the study groupExperimentalstudy group received the traditional physical therapy program plus aquatic therapy
Receives: Other: aquatic therapy
the control groupNo interventioncontrol group received traditional physical therapy program only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Forced Vital Capacity (FVC) will be assessed at day 0.

  2. 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.

    Measured: Forced Vital Capacity (FVC) will be assessed at day 90.

  3. 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.

    Measured: Forced Expiratory Volume (FEV1) will be assessed at day 0.

  4. 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.

    Measured: Forced Expiratory Volume (FEV1) will be assessed at day 90.

  5. 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.

    Measured: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 0.

  6. 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.

    Measured: Forced Expiratory Volume/Forced Vital Capacity Ratio (FEV1/FVC ratio) will be assessed at day 90.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start1 Jun 2020
  3. Primary completion1 Oct 2020 (estimated)
  4. Study completion1 Oct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04574934
Sponsor's protocol ID
P.T.REC/012/002574
Status last verified
Sep 2020
First submitted
5 Aug 2020
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12467755

  • 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.

    PubMed 21333078

  • 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.

    PubMed 23836708

  • 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.

    PubMed 12409823

  • 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.

    PubMed 22938880

Questions about this trial

What is this clinical trial studying?

A study testing aquatic therapy in people with Muscular Dystrophy, run by South Valley University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Vital Capacity (FVC) (time frame: Forced Vital Capacity (FVC) will be assessed at day 0.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04574934, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

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