ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001057370

Ethics application status

Approved

Date submitted

17/07/2017

Date registered

19/07/2017

Date last updated

9/11/2022

Date data sharing statement initially provided

5/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of a physiotherapy exercise program with a self-management approach v's usual care on physical activity in people with mild-moderate Parkinson’s disease: A Randomised Controlled Trial

Scientific title

The effect of a physiotherapy exercise program with a self-management approach v's usual care on physical activity in people with mild-moderate Parkinson’s disease: A Randomised Controlled Trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1199-3683

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Parkinson's disease

Condition category

Condition code

Neurological

Parkinson's disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Group Exercise - Twelve, physiotherapy supervised, small group (3-4 participants) structured exercise sessions over 4 weeks, each 75-80 minutes duration. Each exercise session will include a short group warm up followed by a structured circuit of:
- 30 minutes of treadmill walking conducted at an intensity of 60-80% of heart rate reserve
- Lower limb progressive resistance training targeting hip flexors and extensors and abductors, knee extensors and ankle plantarflexors. Three sets of 8-10 repetitions of each exercise will be performed at 60-80% of the participants one repeat maximum (1RM), with resistance increased by five percent when participants are able to achieve 10 repetitions in their third set at 80% of their 1RM. After the first week of training, participants who demonstrate good technique of strength training exercises will incorporate power training sets 1-2 per session at 40-60% 1RM.
- Balance and gait retraining exercises will be prescribed as needed for each individual incorporating the principles of movement strategy training and highly challenging balance retraining including exercises such as walking with variable speed and focus on big steps with and without gait obstacles.
Each exercise session will end with a group cool down session.

2. Chronic Disease Self-Management (CDSM) – Will be delivered during the same 4-week period that participants are participating in the exercise groups. This will involve 5-10 minute sessions, delivered individually to the participants by the physiotherapists prior to or during the exercise sessions. Participants will be taught behaviour change techniques such as goal setting and action planning to encourage initiation and maintenance of physical activity. At the first exercise session, participants in the intervention group will receive information and a workbook to encourage self-monitoring of physical activity and guide participants through the process of setting short- and long-term goals as well as formulating action plans and coping strategies. During the 4 weeks of exercise sessions and the following 6 months, participants will also be provided with a Garmin Vivosmart armband that monitors and sets goals for physical activity (number of steps / day), and records heart rate, and distance travelled. Physiotherapists will contact participants monthly in the six months following the exercise intervention to discuss their physical activity goals and achievements.
3. Usual care – Participants in the intervention group will continue with their usual Parkinson's disease management. Content, volume and intensity of usual care will be monitored weekly over the 4-weeks following baseline assessment using questionnaires and patient interview.
Group exercise and CDSM will be prescribed and supervised by a registered and physiotherapist with experience in the management of Parkinson’s disease within a physiotherapy rehabilitation gym of a local metropolitan hospital or University clinic.
Usual care will continue to be provided by the participants' chosen health professionals within their chosen environment. The content of usual care will be recorded by the research staff, but will not be influenced by the research staff.

Intervention code [1]

Rehabilitation

Intervention code [2]

Behaviour

Comparator / control treatment

Participants allocated to the control group will continue with their usual Parkinson's disease management. Content, volume and intensity of usual care will be monitored weekly over the 4-weeks following baseline assessment using questionnaires and patient interview. Usual care will continue to be provided by the participants' chosen health professionals within their chosen environment. The content of usual care will be recorded by the research staff, but will not be influenced by the research staff.

Control group

Active

Outcomes

Primary outcome [1]

Free-living physical activity: average number of steps/day over 7-days as measured with the ActivPALTM accelerometer

Timepoint [1]

Baseline (week 0) and the week following conclusion of the 12th exercise session (week 4).

Secondary outcome [1]

Free-living physical activity: average number of steps/day over 7-days as measured with the ActivPALTM accelerometer

Timepoint [1]

Baseline (week 0), follow-up 6 months post intervention (week 26)

Secondary outcome [2]

Free-living physical activity - average daily time spent walking, measured with ActivPALTM accelerometer.

Timepoint [2]

Baseline (week 0), in the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)

Secondary outcome [3]

Free-living physical activity - average daily time spent sedentary measured with ActivPALTM accelerometer.

Timepoint [3]

Baseline (week 0), the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)

Secondary outcome [4]

Free-living physical activity - total minutes/week spent in moderate intensity exercise measured with ActivPALTM accelerometer and Multimedia Activity Recall for Children and Adults (MARCA).

Timepoint [4]

Baseline (week 0), in the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)

Secondary outcome [5]

Step length during single task walking over 8 meters measured using a GAITrite electronic walkway

Timepoint [5]

Baseline (week 0), in the week following conclusion of the 12th exercise session (week 4), follow-up 6 months post intervention (week 26)

Secondary outcome [6]

Gait speed during single task walking over 8 meters measured using a GAITrite electronic walkway

Timepoint [6]