Clinical trial NCT04787861: Motorized Movement Therapy & Pulmonary Functions in Down Syndrome
Official title: Improved Pulmonary Functions and Exercise Capacity in Children With Down Syndrome Following Motorized Movement Therapy: Comparison With Chest Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Functions
Down Syndrome
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome

Detailed description: To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome (DS). Methods: This randomized controlled study included 40 children (24 boys \& 16 girls) with DS. Their ages ranged from 9 to 13 years. The control group received conventional chest physical therapy program, three sessions per week for 12 weeks. The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group. Pulmonary function tests, and six-minutes walking test were measured at baseline, after 18 sessions and after 36 sessions of treatment.

Eligibility criteria: Inclusion Criteria:

* Ability to walk independently
* No involvement in any physical rehabilitation program or sports activity
* Ability to understand and follow orders

Exclusion Criteria:

* Children suffering from obesity
* Severe visual and/or auditory impairment
* Congenital heart disease
* Children with musculoskeletal disorders

Primary outcomes:
measure: Change from baseline in forced expiratory volume in 1st second (FEV1)
timeFrame: Baseline, week 6 and week 12
measure: Change from baseline in forced vital capacity (FVC)
timeFrame: Baseline, week 6 and week 12
measure: Change from baseline in FEV1/FVC ratio
timeFrame: Baseline, week 6 and week 12
measure: Change from baseline in peak expiratory flow rate (PEFR).
timeFrame: Baseline, week 6 and week 12
measure: Change from baseline in maximum voluntary ventilation (MVV)
timeFrame: Baseline, week 6 and week 12
Secondary outcomes:
measure: Six-minutes walking test
timeFrame: Week 1,6 and 12
Other outcomes:
Locations:
city: Al Madīnah
country: Saudi Arabia
facility: Medical Rehabilitation Hospital
state: Al Madinah Al Munawarah
Study officials:
affiliation: Taibah University
name: Hatem A Emara, A.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoshimi K, Ueki J, Seyama K, Takizawa M, Yamaguchi S, Kitahara E, Fukazawa S, Takahama Y, Ichikawa M, Takahashi K, Fukuchi Y. Pulmonary rehabilitation program including respiratory conditioning for chronic obstructive pulmonary disease (COPD): Improved hyperinflation and expiratory flow during tidal breathing. J Thorac Dis. 2012 Jun 1;4(3):259-64. doi: 10.3978/j.issn.2072-1439.2012.03.17.
citation: Pehlivan E, Niksarlioglu EY, Balci A, Kilic L. The Effect of Pulmonary Rehabilitation on the Physical Activity Level and General Clinical Status of Patients with Bronchiectasis. Turk Thorac J. 2019 Jan 1;20(1):30-35. doi: 10.5152/TurkThoracJ.2018.18093.