Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

Improved Pulmonary Functions and Exercise Capacity in Children With Down Syndrome Following Motorized Movement Therapy: Comparison With Chest Physical Therapy

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

Study Overview

• Status: Completed
• Conditions: Down Syndrome; Pulmonary Functions
• Intervention / Treatment: Other: motorized movement therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Madinah Al Munawarah
    • Al Madīnah, Al Madinah Al Munawarah, Saudi Arabia
      • Medical Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Control group treatment is identical to treatment of the study group but without a motorized movement device.Childen in this group received chest physical therapy program including positioning, breathing exercises, and postural drainage in addition to incentive spirometer training for 20 minutes, 3 times/week for 12 weeks.	Other: motorized movement therapy; 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.
Experimental: study group; This group received the same program given to the control group in addition to an aerobic training regimen for 25 minutes 3 times/week for 12 weeks using a motorized movement device.	Other: motorized movement therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in forced expiratory volume in 1st second (FEV1)	FEV1 is the maximal volume of air that can be expired in 1st second of forced vital capacity maneuver using spirometry. We measured FEV1 at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).	Baseline, week 6 and week 12
Change from baseline in forced vital capacity (FVC)	Forced vital capacity (FVC) is the maximal volume of air that can be expired while patient performs forced expiration as fast and as deep as possible using spirometry. We measured FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).	Baseline, week 6 and week 12
Change from baseline in FEV1/FVC ratio	FEV1/FVC is used to differentiate obstructive from restrictive patterns by spirometry. We measuredFEV1/ FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).	Baseline, week 6 and week 12
Change from baseline in peak expiratory flow rate (PEFR).	Peak expiratory flow rate (PEFR).is the maximal flow rate achieved during FVC maneuver using spirometry. We measured PEFR at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).	Baseline, week 6 and week 12
Change from baseline in maximum voluntary ventilation (MVV)	maximum voluntary ventilation (MVV) is the maximal volume of air that can be moved by voluntary ventilation in 1 minute while the patient breathes deeply and rapidly for 12 to 15 seconds using spirometry. We measured MVV at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).	Baseline, week 6 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minutes walking test	The distance covered during of 6 minutes	Week 1,6 and 12

Collaborators and Investigators

• Sponsor: Taibah University
• Investigators: Principal Investigator: Hatem A Emara, A.Prof, Taibah University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): March 7, 2020
• Study Completion (Actual): May 4, 2020

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: Down Syndrome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No