Clinical trial NCT03974529: Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms
Official title: Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Intensive running
Gait
Balance
Motor symptoms of Parkinson's disease
Non-motor symptoms of Parkinson's disease
UPDRS score
Physiotherapy
Quality of life
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2019-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled single-blinded study. 30 patients will be included and randomized to intervention arm or control arm in a ratio of 2 to 1. Informed consent will be signed after the patient is fully informed about the procedures and prior to the baseline assessments.

Intervention arm

* Number of participants: 20
* Venue: Shatin playground
* Supervisors: licensed coaches (2 to 4 per session)
* Training session: 30 minutes of warm-up stretching + 60 minutes supervised progressive aerobic endurance track running
* Targeted intensity: 60-75% of maximum heart rate (HR max = 220 - age) OR 40-50% heart rate reserve (HRR= HR max - HR rest)
* Frequency and training period: 2 sessions per week, for 24 weeks

Control arm

* Number of participants: 10
* Venue: Indoor gymnasium
* Supervisor: a physiotherapist
* Training session: 60 minutes of physical stretching
* Frequency and training period: 1 session per week, for 24 weeks
Primary purpose: TREATMENT

Brief summary: High quality clinical trial and meta-analysis have demonstrated short term, and to a lesser extent, long term benefits in various outcome measures. To achieve positive effects, supervised progressive strength and aerobic endurance training program of 12 weeks was required. Extended progressive strength training improved muscle strength for up to 24 months. While aerobic endurance training would increase walking capacity up to 16 months. 1 There are data suggesting a threshold of intensity of exercise to be reached for the positive effect. This overall body of evidence suggests that regular vigorous exercise should be accorded a central place in the treatment of Parkinson's disease.

However, there was no evidence about regular intensive exercise of running in Parkinson's disease. And most of the studies were not randomized with a control group.

In this study, the investigators are to investigate the effect of regular vigorous aerobic exercise training of running on motor and non-motor symptoms, and quality-of-life of people with Parkinson's disease.

Detailed description: There is growing volume of evidences support the positive effect of exercise and physical therapy to Parkinson's disease. Various exercise types have shown different positive effects. Gait training for 4 weeks showed a moderate improvement in balancing while balance training of 8 to 26 weeks decreased fall rate. Cued exercise would mildly increase the speed of the gait. Complementary exercises, such as Tai Chi and dancing, have shown improvement in balancing of the patients.

One of the main complaints of Parkinson's disease is rigidity. It is because of the musculoskeletal impairments which compromise the flexibility and stability of both axial structure (spine) and the extremities. Truncal stiffness and rigidity results in a stooped posture, which further undermines one's balance and agility. Flexibility training (stretching) is shown to be beneficial to all stages of patients with Parkinson's disease, in terms of improved both range of movement in joints and spinal stability. It is recommended that regular stretching should be the first step in one's exercise program to combat the muscle rigidity. High quality clinical trial and meta-analysis have demonstrated short term, and to a lesser extent, long term benefits in various outcome measures. To achieve positive effects, supervised progressive strength and aerobic endurance training program of 12 weeks was required. Extended progressive strength training improved muscle strength for up to 24 months. While aerobic endurance training would increase walking capacity up to 16 months.

There are data suggested a threshold of intensity of exercise to be reached for the positive effect. This overall body of evidence suggests that regular vigorous exercise should be accorded a central place in the treatment of Parkinson's disease.

In this study, the investigators are to investigate the effect of regular vigorous aerobic exercise training of running on motor and non-motor symptoms, and quality-of-life of people with Parkinson's disease.

Eligibility criteria: Inclusion Criteria:

1. Patient with idiopathic Parkinson's disease, aging from 40 years to 60 years old.
2. Patient who are able to walk independently without walking aids for a distance of 30 meters.

Exclusion Criteria:

1. Previous history of other neuro-degenerative diseases
2. Presence of ischemic heart disease or musculoskeletal and cardiopulmonary diseases
3. Presence of physical disability
4. History of regular running practice in the past 6 months.

Primary outcomes:
measure: Unified Parkinson's disease rating scale Overall Score
timeFrame: Six months after finishing the training
measure: Parkinson's Disease Questionnaire - 39 (PDQ39) Quality of Life Score
timeFrame: Six months after finishing the training
Secondary outcomes:
measure: Endurance
timeFrame: Six months after finishing the trainingBaseline, one month after finishing the training, and six months after finishing the training
measure: Gait performance
timeFrame: Six months after finishing the training
measure: MiniBest Test Score
timeFrame: Six months after finishing the training
measure: Mood
timeFrame: Six months after finishing the training
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Danny TM Chan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.