Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787861
• Other study ID #: Down Syndrome
• Status: Completed
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: May 4, 2020

Study information

• Verified date: March 2021
• Source: Taibah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 4, 2020
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Pulmonary Functions
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Medical Rehabilitation Hospital	Al Madinah	Al Madinah Al Munawarah

Sponsors (1)

Lead Sponsor	Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (2)

Pehlivan E, Niksarlioglu EY, Balci A, Kiliç 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Six-minutes walking test	The distance covered during of 6 minutes	Week 1,6 and 12