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Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

Primary Purpose

Pulmonary Functions, Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
motorized movement therapy
Sponsored by
Taibah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Functions

Eligibility Criteria

9 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

study group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).

Secondary Outcome Measures

Six-minutes walking test
The distance covered during of 6 minutes

Full Information

First Posted
February 12, 2021
Last Updated
March 4, 2021
Sponsor
Taibah University
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1. Study Identification

Unique Protocol Identification Number
NCT04787861
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
March 7, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taibah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Functions, Down Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
motorized movement therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in forced expiratory volume in 1st second (FEV1)
Description
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).
Time Frame
Baseline, week 6 and week 12
Title
Change from baseline in forced vital capacity (FVC)
Description
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).
Time Frame
Baseline, week 6 and week 12
Title
Change from baseline in FEV1/FVC ratio
Description
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).
Time Frame
Baseline, week 6 and week 12
Title
Change from baseline in peak expiratory flow rate (PEFR).
Description
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).
Time Frame
Baseline, week 6 and week 12
Title
Change from baseline in maximum voluntary ventilation (MVV)
Description
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).
Time Frame
Baseline, week 6 and week 12
Secondary Outcome Measure Information:
Title
Six-minutes walking test
Description
The distance covered during of 6 minutes
Time Frame
Week 1,6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem A Emara, A.Prof
Organizational Affiliation
Taibah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Rehabilitation Hospital
City
Al Madīnah
State/Province
Al Madinah Al Munawarah
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22754664
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.
Results Reference
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PubMed Identifier
30664424
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.
Results Reference
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Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

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