Multimodal Exercise Program on Parkinson's Disease Patients With Depression

NCT ID: NCT03752346

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-01-31

Brief Summary

Depression symptoms are common in Parkinson's Disease, it affects health-related quality of life. The evidence showed that exercise improved depression and HRQOL in PD patients. However, studies rarely considered the appropriate exercise program for PD patients, we want to find the best exercise program for PD patients.

Detailed Description

Objective: Evaluate the effectiveness of a 8-week multimodal exercise program on depression and HRQOL in PD Patients.

Methods: Single-blinded, randomized controlled trial, from March 2016 to January 2017. Ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n = 49). The primary outcomes were depression and HRQOL; the secondary outcomes were activity of daily living, motor ability, fatigue, sleep quality and anxiety. Data collection at baseline, week 4 and 8 after intervention. Intervention were Multimodal Exercise Program, at least three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to accumulate 150 minutes a week for 8 weeks.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

control group

Control group maintained their regular lifestyle and received the routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

exercise group

Participants in the exercise group (EG) were instructed to engage performed exercise at least 3 times per week (30-50 minutes) or 10-15 minutes per section every day to accumulate 150 minutes per week for 8 weeks using disc (DVD) at home. Main exercise was moderate intensity aerobic exercise, an intensity of 55-70% of the heart rate reserve (HR max).

Group Type: EXPERIMENTAL

exercise group

Intervention Type: OTHER

A step aerobics exercise lasted a total 30 minutes, including:

1. a warm-up with 10 minutes of stretching exercises.

2. A step aerobics exercise (step aerobics for 30 minutes; step by step, step exercise, or stepping the ground repetitively)23,24 a total of 30 minutes then cool down (5 minutes).

3. Resistance training (10 minutes), stretching and relaxation for 10-15 minutes.

Interventions

exercise group

A step aerobics exercise lasted a total 30 minutes, including:

1. a warm-up with 10 minutes of stretching exercises.

2. A step aerobics exercise (step aerobics for 30 minutes; step by step, step exercise, or stepping the ground repetitively)23,24 a total of 30 minutes then cool down (5 minutes).

3. Resistance training (10 minutes), stretching and relaxation for 10-15 minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• be diagnosed PD in Hoehn and Yahr stage I-II22
• under stable medication treatment at least 3 months
• no disease limiting the patient's ability to perform the exercises

Exclusion Criteria

• severe cardiovascular disorders
• neuromusculoskeletal disorder
• cognitive impairment
• recent participation in any physiotherapy or rehabilitation program
• have exercise regularly

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

151223

Identifier Type: -

Identifier Source: org_study_id