Prader-Willi Syndrome Body Composition

NCT ID: NCT04597645

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-06
• Study Completion Date: 2021-07-31

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.

Detailed 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.

Conditions

Prader Labhart Willi Syndrome; Body Weight Changes; Sarcopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Elastic band (EB)

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.

Group Type: EXPERIMENTAL

Therapeutic elastic band resistance training

Intervention Type: 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.

Control group (CG)

Control group participants will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Therapeutic elastic band resistance training

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valeria Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Locations

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

TCRD-TPE-109-55

Identifier Type: -

Identifier Source: org_study_id