Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot (PLIÉ-pilot)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 1

Conditions: Dementia

Treatments: Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)

Study type: Interventional

Funder types: Other

Identifiers

NCT01371214

10-04080-023906

Details and patient eligibility

About

The primary goal of this study is to perform a 36-week pilot study with a cross-over design to study the safety and efficacy of a novel integrative exercise program called PLIÉ (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and Western exercise traditions and is specifically designed to target the muscles and movements needed to help individuals with mild-to-moderate dementia maintain physical function and independence.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Primary Participant:

• Current participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
• Recommended by Swindells staff
• mild-to-moderate dementia
• caregiver consent

Inclusion Criteria - Caregiver:

• Provide care to primary participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
• can provide information about the primary participant's physical functioning, behaviors, falls, quality of life and own level of stress.

Exclusion Criteria - Primary Participant:

• major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
• life expectancy < 1 year (e.g., metastatic cancer)
• inability to assent to study procedures

Exclusion Criteria - Caregiver:

• Any major neurologic disease (e.g., dementia, stroke, Parkinson's disease, ALS)
• major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
• life expectancy < 1 year (e.g., metastatic cancer)
• evidence of cognitive impairment
• inability to consent to study procedures.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Group 1

Experimental group

Description:

PLIÉ exercise program 30-45 minutes, 2-3 days/week for 18 weeks followed by 18 weeks of usual care (20-minutes of chair-based exercises 2-5 days/week).

Treatment:

Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)

Group 2

Active Comparator group

Description:

Usual care (20 minutes of chair-based exercises 2-5 days/week) for 18 weeks followed by the PLIÉ exercise program 30-45 minutes/day, 2-3 days/week for 18 weeks.

Treatment:

Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)