Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

NCT04787861 | Completed

• 1 other identifier: Down Syndrome
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Functions; Down Syndrome

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Six-minutes walking test

  Week 1,6 and 12

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

study group

EXPERIMENTAL

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

Interventions

motorized movement therapy OTHER

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.

Control group; study group

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taibah University: lead

Study Sites (1)

Medical Rehabilitation Hospital

Al Madīnah, Al Madinah Al Munawarah, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 22754664 BACKGROUND

• 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.

  PMID: 30664424 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Hatem A Emara, A.Prof

  Taibah University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: March 9, 2021
• Study Start: December 17, 2018
• Primary Completion: March 7, 2020
• Study Completion: May 4, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

SA (1)