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CompletedNCT03882398Updated Mar 20, 2019

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

An interventional study of Balance and Endurance in Parkinson Disease, Exercise and Physical Activity, sponsored by University of Vigo. Completed at 1 site in Spain. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by University of Vigo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Parkinson Disease
  • Exercise
  • Physical Activity
  • Quality of Life

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Keywords

  • Neurodegenerative disorders
  • physical activity
  • balance
  • endurance
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 14 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Vigo is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History or evidence of dementia or other neurological impairment/cardiovascular diseases that may affect the high-intensity endurance workout
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

  • 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 · Other: Endurance

  • Active comparator
    Control Group

    The control group (CG) only performed routine balance exercises once a week (10 min)

    Other: Balance

Interventions

  • OtherBalance

    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)

  • OtherEndurance

    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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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

    Time frame: 12 weeks

  4. 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

    Time frame: 12 weeks

07

Study locations

1 site
  • Universidad de Vigo
    Pontevedra, 36005, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03882398
Lead sponsor
University of Vigo
Responsible party
José M. Cancela (Principal Investigator, University of Vigo) — Principal investigator
First posted
Mar 20, 2019
Start date
Feb 15, 2018
Primary completion
Mar 1, 2018
Completion
Jun 1, 2018
Last update
Mar 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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