A Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

A Randomised Controlled Feasibility Study of a Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737316
• Other study ID #: 2021/00768
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: Tan Tock Seng Hospital
• Contact: lauha Chung, PhD
• Phone: +6563578305
• Email: chloe_lh_chung[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to evaluate the (1) feasibility of a novel mobile application ( Combat PD) that support a home-based gamified aerobic exercise program in individuals with mild Parkinson's disease (PD).

The study aims to further explore (2) the effectiveness of Combat PD in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat PD in improving motor and non-motor function in PD.

Description:

This study aim to evaluate the (1) feasibility of a novel mobile application ( Combat PD) that support a home-based gamified aerobic exercise program in individuals with mild Parkinson's disease (PD).

The study aims to further explore (2) the effectiveness of Combat PD in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat PD in improving motor and non-motor function in PD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged 30-75, diagnosed with Parkinson's disease, with mild disease severity (Hoehn and Yahr stages I to II)

2. Sedentary lifestyle

3. Receive a stable dose of dopaminergic medication for at least 4 weeks prior to study inclusion

4. Has a smart phone device

Exclusion Criteria:

1. Uncontrolled hypertension, arrhythmia, or unstable cardiovascular status

2. Poorly controlled diabetes mellitus

3. Advanced kidney disease

4. BMI > 30

5. Recent cerebrovascular event/ concussion/ fall in the last 6 months

6. Significant cognitive impairment (MoCA<21)

7. Any other medical/orthopaedic/psychiatric condition that would interfere with ability to participate in the study

8. No stable internet or smart device access

9. Inability to fill up self-reported questionnaires

10. Attendance at any regular exercise programme up to 4 weeks prior to study inclusion

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Combat PD
CombatPD is an aerobic exercise programme hosted on a mobile application that pairs with motion sensors and heart rate monitor, which connects to a web-based portal for remote monitoring. The wearable sensors consist of (i) 2 motion sensors worn across one thigh and attached to an exercise ring which is held by the participant during the exergame and (ii) 1 heart rate sensor worn across the participant's chest. They will receive once weekly physiotherapy sessions at the study site for the first 4 weeks where they will be guided through the use of the CombatPD. Participants will be instructed to perform 2 sessions of 30-minute exergames in addition to a session of 30-minute brisk walking every week for 12 weeks at home. They will be instructed to exercise at a target heart rate zone at moderate intensity (i.e., 40% - 60% Heart Rate Reserve), which will be gradually increased.
• Usual Care
Participants in the control group (usual care) will receive once weekly physiotherapy sessions for first 2 weeks and another session at week 6 where they will be taught home exercises based on a standard PD exercise booklet, consisting mainly of range of motion and stretching exercises , as well as brisk walking techniques. Participants in the control group will be instructed to perform these home exercises twice a week, in addition to a 30-minute brisk walk for 12 weeks.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Singhealth Foundation

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Canning CG, Allen NE, Dean CM, Goh L, Fung VS. Home-based treadmill training for individuals with Parkinson's disease: a randomized controlled pilot trial. Clin Rehabil. 2012 Sep;26(9):817-26. doi: 10.1177/0269215511432652. Epub 2012 Jan 18. — View Citation

van der Kolk NM, de Vries NM, Penko AL, van der Vlugt M, Mulder AA, Post B, Alberts JL, Bloem BR. A remotely supervised home-based aerobic exercise programme is feasible for patients with Parkinson's disease: results of a small randomised feasibility trial. J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):1003-1005. doi: 10.1136/jnnp-2017-315728. Epub 2017 Jun 12. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to exercise program	actual exercise frequency compared to prescribed exercise targets.	12 weeks
Primary	Adherence to exercise program	actual exercise duration compared to prescribed exercise targets.	12 weeks
Primary	Adherence to exercise program	actual exercise intensity (period of exercise performed within prescribed heart rate zone), compared to prescribed exercise targets.	12 weeks
Secondary	Adverse events	Falls, musculoskeletal injuries, shortness of breath, dizziness, and fatigue.	12 weeks
Secondary	Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)	Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III) is a valid and reliable clinical test to evaluate the severity of motor symptoms of PD, score range 0-132, 32 and below is mild, 59 and above is severe.	12 weeks
Secondary	Timed Up and Go test (TUG)	The TUG test measures the time in seconds taken by participants to perform sequential locomotor tasks that incorporate walking and turning.	12 weeks
Secondary	Dual-task Timed Up and Go Test (TUG)	Participants were instructed to repeat the TUG procedure while performing a serial three subtraction.	12 weeks
Secondary	6-minute walk test	The maximal distance covered over a time of 6 minute.	12 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA is a widely used screening assessment for detecting cognitive impairment, The basics of this test include short-term memory, executable performance, attention, focus and more. Score range 0-30. A score of 26 or over is considered to be normal.	12 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	A reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from 0 to 3, with 3 denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.	12 weeks
Secondary	Fatigue Severity Scale (FSS)	The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Score range from 9-63, higher the score denotes greater fatigue severity.	12 weeks
Secondary	Scales for Outcomes in Parkinson's disease (SCOPA-sleep)	SCOPA-sleep is a reliable and valid patient-completed instrument for assessing nighttime sleep (5 items, 0-4) and daytime sleepiness (6 items 0-4) in patients with PD. with two additional questions on use of sleeping tablet ( 0-4) and Global evaluation of sleeping at night (0-7), sum up to total score of 55, higher score denotes worst sleeping performance.	12 weeks
Secondary	Parkinson Disease Questionnaire (PDQ)-8	It's a self-administered questionnaire, used to measure quality of life in persons with PD. It is an eight-question instrument and each score is scored between 0 and 4. Total score sum up to 32, a higher score signifies poorer quality of life.	12 weeks