Prader-Willi Syndrome Body Composition

NCT04597645 | Completed

• 1 other identifier: TCRD-TPE-109-55
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Adults aged over 18 years, with the diagnosis of Prader-willi syndrome will be recruited through the hospital's outpatient clinic for either as intervention group receiving therapeutic elastic band training, or as control group receiving usual care for a total of 16 weeks. Body composition, physical capacity, and serum changes will be assessed before and after the intervention.

Conditions

Prader Labhart Willi Syndrome; Body Weight Changes; Sarcopenia

Keywords

Prader Willi Syndrome; Body composition; Sarcopenia; Resistance training; Physical capacity

Outcome Measures

Primary Outcomes (2)

• Change in lean tissue mass and adipose tissue mass

  Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA).

  Baseline and 4 month follow up

• Change in body mass index

  Body mass index will be calculated as the body mass in kilograms divided by the square of the height in meters.

  Baseline and 4 month follow up

Secondary Outcomes (8)

• Change in grip muscle strength

  Baseline and 4 month follow up

• Change in 30-second sit to stand test

  Baseline and 4 month follow up

• Change in timed up and go test

  Baseline and 4 month follow up

• Change in two minute step up test

  Baseline and 4 month follow up

• Change in Berg balance scale

  Baseline and 4 month follow up

Other Outcomes (2)

• Change in appendicular skeletal muscle mass and lower extremity skeletal muscle mass

  Baseline and 4 month follow up

• Change in skeletal muscle mass index and lower extremity skeletal muscle mass index

  Baseline and 4 month follow up

Study Arms (2)

Elastic band (EB)

EXPERIMENTAL

EB group participants who are attending sheltered employment will received Elastic Thera band training program two times per week (once supervised and guided by a trained physical therapist and the other supervised by educational trainer) over 16 weeks for a total of 32 sessions.

Other: Therapeutic elastic band resistance training

Control group (CG)

NO INTERVENTION

Control group participants will receive usual care.

Interventions

Therapeutic elastic band resistance training OTHER

A16-week therapeutic program using Elastic Thera Band will be taught. The exercises are designed to train specific major muscle groups, strengthen the motivation of participants, and facilitate home-based compliance. The program will be performed two times per week (once supervised and guided by a trained physical therapist and the other supervised by educational trainers) over 16 weeks for a total of 32 sessions. Each session supervised by a physical therapist last for 60 minutes, including a 5-minute warm-up consisting of light-intensity aerobic and dynamic stretching exercises, followed by 50 minutes of EB exercise and a 5-minute period of cool-down and static stretching exercises.

Elastic band (EB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years old.
• Genetically diagnosis of Prader-willi syndrome.
• Must be able to follow and understand mandarin instructions and cooperate to the exercise assessments and/or training.

You may not qualify if:

• Prader-willi syndrome individuals unable to sit, stand and walk independently which make physical capacity assessment difficult.
• Severe arthritis, fracture, or other musculoskeletal deformities that interfere with exercise training.
• Severe cognitive impairment who cannot read, write the informed consent.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, 231, Taiwan

Location

MeSH Terms

Conditions

Prader-Willi Syndrome; Body Weight Changes; Sarcopenia

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; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Valeria Chiu, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: October 22, 2020
• Study Start: May 6, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: May 3, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)