Bicycle Ergometer Training in Duchenne Muscular Dystrophy (BETDMD)

• ClinicalTrials.gov Identifier: NCT05330195
• Recruitment Status: Completed
• First Posted: April 15, 2022
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Numan Bulut, Hacettepe University

Study Description

Brief Summary:

The progressive muscle weakness and contractures of the patients adversely affect their gait and balance. It is known that the disorder of the patients' balance and gait affects their functional capacity. The aim of this study is to examine the effects of bicycle ergometer training on gait and balance in children with Duchenne Muscular Dystrophy. Twenty-four children with DMD included in the study will be divided into two groups as home program and home program+bicycle ergometer training with block randomization method. Home program including stretching, respiratory, range of motion, posture and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period. Gait and balance were evaluated with GAITrite and Bertec Balance Check Screener, successively. Assessments will be applied at pre-training and after 12 weeks of training.

Condition or disease	Intervention/treatment	Phase
Duchenne Muscular Dystrophy	Other: Bicycle Ergometer Training; Other: Home-based exercise group	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Block Randomized controlled study
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Bicycle Training on Gait and Balance in Children With Duchenne Muscular Dystrophy
• Actual Study Start Date: April 18, 2022
• Actual Primary Completion Date: July 29, 2022
• Actual Study Completion Date: November 18, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group; Home exercise program Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week. Also, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group	Other: Bicycle Ergometer Training; Bicycle ergometer training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group.; Other: Home-based exercise group; Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.
Active Comparator: Control Group; Home Based Exercise Group Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do this program for 3-5 days a week.	Other: Home-based exercise group; Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.

Outcome Measures

Primary Outcome Measures :

1. Step Time and Cycle Time(Gait) [ Time Frame: 5 minutes ]
   The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, ambulation time (s) was evaluated.
2. Step Length, Stride Length and base of support (Gait) [ Time Frame: 5 minutes ]
   The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system,step length (cm), stride length (cm) and base of support (cm) were evaluated.
3. Single support, double support, swing phase and stance phase (Gait) [ Time Frame: 5 minutes ]
   The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, single support, double support, swing phase and stance phase were stated as %.
4. Velocity (Gait) [ Time Frame: 5 minutes ]
   The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, Velocity (cm/s) was evaluated.
5. Cadence (Gait) [ Time Frame: 5 minutes ]
   The gait of patients with DMD was assessed by GAITrite (CIR Systems Inc., Franklin, New Jersey, USA) electronic walkway system, objective assessment of spatio-temporal characteristics of gait, at a self-selected speed for 3 times. With this walkway system, cadence (steps/min) was recorded.
6. Balance (rigid surface) [ Time Frame: 10 minutes ]
   The balance plate system used to assess balance and degree of postural sway was the Bertec Balance Check Screener™ (BP5050 Bertec Co., Columbus, OH, USA). The system consists of a 20 × 20-inch platform at ground level connected to a computer. Postural sway, which measures the displacement of the center of gravity, was assessed on rigid surface, in 2 conditions (eyes opened-closed) and 2 directions (anteroposterior and mediolateral).
7. Balance (perturbated surface) [ Time Frame: 10 minutes ]
   The balance plate system used to assess balance and degree of postural sway was the Bertec Balance Check Screener™ (BP5050 Bertec Co., Columbus, OH, USA). The system consists of a 20 × 20-inch platform at ground level connected to a computer. Postural sway, which measures the displacement of the center of gravity, was assessed on perturbated surface, in 2 conditions (eyes opened-closed) and 2 directions (anteroposterior and mediolateral).

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 12 Years (Child)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Because DMD is X linked recessive disorder, this disorder is seen in male.
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Children have diagnosis of DMD confirmed by genetic analysis,
• Children can walk with unsupported.

Exclusion criteria:

• Children have undergone any surgery or suffered injury of the lower limbs,
• Children have severe contractures of lower limbs,
• Children have low cooperation
• Children have comorbid disease,
• Children were applied regular aerobic training such as bicycle training and hydrotherapy in last 6 months.

Contacts and Locations

Locations

Turkey

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, Turkey, 06100

Sponsors and Collaborators

Hacettepe University

More Information

• Responsible Party: Numan Bulut, Research Assistant (Assistant of neuromuscular disorders unit), Hacettepe University
• ClinicalTrials.gov Identifier: NCT05330195
• Other Study ID Numbers: 2022008
• First Posted: April 15, 2022
• Last Update Posted: December 15, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Numan Bulut, Hacettepe University:

Duchenne muscular dystrophy; Bicycle training; Gait; Balance

Additional relevant MeSH terms:

Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked