Multimodal Exercise Program on Parkinson's Disease Patients With Depression

NCT03752346 | Completed DMC

• 1 other identifier: 151223
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; A Multimodal Exercise Program; Aerobic Exercise; Depression; Health Related Quality of Life

Outcome Measures

Primary Outcomes (2)

• GDS-15

  consisting of 15 questions, was the primary outcome evaluator (Sheikh and Yesavage, 1986). Scores of 0-4 are considered to be normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.

  3 minutes

• PDQ-8

  A sub-set of items is then selected from the PDQ-39 to create a shorter form version, the PDQ-8 (Jenkinson, Fitzpatrick \& Peto, 1997). The sum of the scores can provide a single figure used to assess the overall health-related quality of life profile of the individual questioned. . Scores for each dimension range from 0 to 100, PDQ-8SI scores can be standardized on a scale from 0 to 100, with lower scores indicating better HRQoL.

  3 minutes

Secondary Outcomes (5)

• UPDRS part II (ADL)

  5 minutes

• UPDRS part III (motor ability)

  10 minutes

• Fatigue (FSS)

  5 minutes

• Sleep quality (PSQI)

  5 minutes

• Anxiety (HAS)

  3 minutes

Study Arms (2)

control group

NO INTERVENTION

Control group maintained their regular lifestyle and received the routine care

exercise group

EXPERIMENTAL

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).

Other: exercise group

Interventions

exercise group 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.

exercise group

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Parkinson Disease; Depression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Study Design

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

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 26, 2018
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share