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Prader-Willi Syndrome Body Composition

B

Buddhist Tzu Chi Medical Foundation

Status

Completed

Conditions

Sarcopenia
Body Weight Changes
Prader Labhart Willi Syndrome

Treatments

Other: Therapeutic elastic band resistance training

Study type

Interventional

Funder types

Other

Identifiers

NCT04597645
TCRD-TPE-109-55

Details and patient eligibility

About

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.

Full description

Participants that fulfill the inclusion criteria will be assigned into one of the two arms: elastic band intervention group (EB) or control group (CG). Both groups will received a baseline: dual X-ray absorptiometry body composition, physical capacity, and serum markers examinations. EB will then receive a 16-week progressive elastic band resistance exercise training, while the CG will receive usual care. After the 16 weeks from the baseline assessment, a followed-up: dual X-ray absorptiometry body composition, physical capacity, and serum examinations will be assessed.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Elastic band (EB)
Experimental group
Description:
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.
Treatment:
Other: Therapeutic elastic band resistance training
Control group (CG)
No Intervention group
Description:
Control group participants will receive usual care.

Trial contacts and locations

1

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Central trial contact

Valeria Chiu, M.D

Data sourced from clinicaltrials.gov

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