Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease

Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease Population: a Pilot Randomized Controlled Trial

TITLE: Effects of a high-intensity progressive-cycle program on quality of life and motor symptomatology in Parkinson's disease population

BACKGROUND: The benefits of aerobic exercise in persons with Parkinson's disease (PD) have been widely studied; however, little research has been done on the effect of high-intensity aerobic exercise in this group.

HYPOTHESIS: The high-intensity aerobic training in pedaliers, combined with balance training, improves motor symptoms and quality of life in a population with Parkinson Disease, Hoehn & Yahr 1-3.

OBJETIVES: To ascertain whether high-intensity aerobic training with exercise peddlers and balance training can improve motor symptoms and quality of life in a PD population of Hoehn &Yahr (H&Y) disability score 1-3.

METHODOLOGY Setting: Rehabilitation centers in secondary care. Design: A pilot randomized controlled trial. Participants: A total of 14 patients participated in the 8-week study. Interventions: They were comprised of a control group (n=7) that followed a balance protocol and an experimental group (n=7) that performed high intensity (70%) aerobic workout using an exercise peddler + a balance protocol once a week.

Main Outcome Measures: The primary outcome measures included the 8-Foot Up and Go, test, 6-minute walk test, test 2-minute step tets, Parkinson Disease Questionnaire-39 (PDQ39), Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Tinetti test.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Physical Activity; Parkinson Disease; Exercise
• Intervention / Treatment: Other: Balance; Other: Endurance

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Pontevedra, Spain, 36005
    • Universidad de Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with Parkinson Disease, Hoehn & Yahr score of 1-3.

Exclusion Criteria:

• History or evidence of dementia or other neurological impairment/cardiovascular diseases that may affect the high-intensity endurance workout

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The experimental group (EG) participated in a once a week physical exercise program for 8 weeks. The session consisted of balance training, followed by aerobic endurance training with exercise peddlers. At the beginning of the program, each session lasted 25 minutes and progressed to 35 minutes, in the last two weeks	Other: Balance; Balance program (10 minutes) Balance on bosu ball and ball drills Coordination in rings with single leg stance and ball drills Straight line walk with head up Straight line walk and hip flexion, knee flexion and head up (Duration: 10 minutes. Sets: 2 minutes per exercise. Rest: 30 seconds between exercises); Other: Endurance; Progressive-cycle program (15-25 minutes) Warming up Pedalling with 0 resistance (2 minutes) Main Part* Week 1-2 : 3x2 minutes Week 3-4 : 4x2 minutes Week 5-6 : 5x2 minutes Week 7-8 : 6x2 minutes Return to resting stage Pedalling with 0 resistance (1 minute) (*Pedalling with resistance set at 3-4. Rest: 2 minutes between sets or 120 beats/minute. One more set added every two weeks and workout intensity maintained at 70% of heart rate reserve-HRR)
Active Comparator: Control Group; The control group (CG) only performed routine balance exercises once a week (10 min)	Other: Balance; Balance program (10 minutes) Balance on bosu ball and ball drills Coordination in rings with single leg stance and ball drills Straight line walk with head up Straight line walk and hip flexion, knee flexion and head up (Duration: 10 minutes. Sets: 2 minutes per exercise. Rest: 30 seconds between exercises)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sintomatology of Parkinson Disease	The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates the degree of symptomatology of the person with Parkinson's Disease. The total score range ranges from 0 to 200, with higher values indicating a greater impact of the symptoms. Each item is scored from 0 to 4, with 0 being the least and 4 the most severe. The scores are added.	12 weeks
Quality of life in Parkinson Disease: PDQ39	The quality of life questionnaire for Parkinson's disease is a specific questionnaire that evaluates the quality of life, where a lower score means that the patient has a better quality of life. It consists of 39 questions, and its value is expressed in percentages, the percentages closest to zero express a better quality of life. In addition, their results can also be expressed in 8 different areas (mobility, activities of daily life, stigma, emotional well-being, social support, communication, body discomfort, cognitive impairment), which are interpreted in the same way.	12 weeks
Physical Conditions	The Senior Fitness Test, is a battery of 7 tests to evaluate the physical state of the elderly, and has been validated for people with Parkinson's Disease. This battery evaluates the strength of lower and upper limbs with the 30 seconds chair stand and arm curl tests, to more repetitions, more strength. It also evaluates the flexibility of both lower and upper limbs with the chair sit and reach and back stractch tests, which are measured in centimeters, to more centimeters greater flexibility. Aerobic endurance is assessed by means of the 6 minute walk test that is measured in meters, and the 2 minute step test that is measured in cycles. The more number of cycles and meters, the better aerobic resistance. The balance is evaluated by means of the 8 foot up and go test, which is measured in seconds, and the less the better the balance. These results by means of a mathematical formula give an absolute value that to higher score better physical condition	12 weeks
Balance	Tinetti test The objective of the Tinetti test is to evaluate the possible alterations of balance in a population of elderly people. The test consists of two parts: nine elements of balance and six elements of march. The maximum total score is 28, and would mean that gait and balance are normal	12 weeks

Collaborators and Investigators

• Sponsor: University of Vigo

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; balance; endurance; Neurodegenerative disorders
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No