Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001108202
Ethics application status
Approved
Date submitted
18/05/2018
Date registered
4/07/2018
Date last updated
4/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is water-based exercise as effective as land-based exercise in improving walking speed and leg muscle strength in stroke survivors?
Scientific title
Is aquatic plyometric exercise as effective as land-based plyometric exercise in improving gait speed, lower limb muscle power and endurance in stroke survivors - a randomised cross-over trial.
Secondary ID [1] 294315 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Stroke 308607 0
Condition category
Condition code
Stroke 307557 307557 0 0
Haemorrhagic
Stroke 307558 307558 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cross over trial design comparing an aquatic plyometric program with a land-based plyometric program. There will be a one week wash-out between the two different interventions.
Aquatic plyometric program:
1. the aquatic program was developed in collaboration with a physiotherapist who has over 20 years of clinical experience in the delivery of aquatic exercise (AR). The program was developed using a combination of clinical experience and existing evidence-based literature for plyometric training principles

2. The program will be delivered as a small group program by the undergraduate honours physiotherapy student and supervised by one of the two experienced physiotherapists involved in the study

3. participants will attend the aquatic exercise group twice a week for two weeks

4. the aquatic program will be delivered in a public hydrotherapy facility close to where the participants live. The pool is an enclosed purpose-built hydrotherapy pool with both stair and hoist access. The water temperature is maintained at 32 degrees, and the depth is between 1m to 1.2m and appropriate for this project.

5. The program will take 30 mins and has total footfalls of 120 per class. Plyometric programs for healthy young athletes are usually around 240 footfalls per session so 120 per class was chosen as a conservative estimate for the chronic stroke survivors in the study

6. the program includes two sets of 10 reps of five plyometric exercises with 60 secs rest between sets and 3 minutes rest between each exercise
- warm up 5 mins walking across the pool in waist deep water
- 2 footed vertical jump in chest deep water
- high knee marching on the spot in chest deep water
- squat jump waist deep water
- skip (step hop) in chest deep water
- bounding from one foot to the other in chest deep water
- warm down 5 mins walking across the pool

7. attendance and individual exercise records will be maintained to determine adherence
Intervention code [1] 301247 0
Rehabilitation
Comparator / control treatment
the comparator is the land-based plyometric program.
Details of the land-based plyometric program are as follows:
Land-based plyometric program:
1. the land-based program was developed in collaboration with a physiotherapist who has over 12 years of clinical experience in the delivery of land-based exercise for older adults (VN). The program was developed using a combination of clinical experience and existing evidence-based literature for plyometric training principles

2. The program will be delivered as a small group program by the undergraduate honours physiotherapy student and supervised by one of the two experienced physiotherapists involved in the study

3. participants will attend the land-based exercise group twice a week for two weeks

4. the land-based program will be delivered in the University Health Clinic rehabilitation gym which has suitable space available and equipment such as parallel bars should these be required for stability and balance

5. The program includes the same exercises as the aquatic program. Similarly, each session will take 30 mins and has total footfalls of 120 per class. Plyometric programs for healthy young athletes are usually around 240 footfalls per session so 120 per class was chosen as a conservative estimate for the chronic stroke survivors in the study

6. the program includes two sets of 10 reps of five plyometric exercises with 60 secs rest between sets and 3 minutes rest between each exercise
- warm up 5 mins walking laps of the gym / outside
- 2 footed vertical jump
- high knee marching on the spot
- squat jump
- skip (step hop)
- bounding from one foot to the other
- warm down 5 mins walking around the gym or outside

7. attendance and individual exercise records will be maintained to determine adherence
Control group
Active

Outcomes
Primary outcome [1] 305929 0
Gait velocity
a. Will be measured by walking along an 8m GAITrite mat
b. Three repetitions “walking at a comfortable speed”
c. Three repetitions “walking as quickly as safely possible without running”
The average gait velocity for each speed will be recorded
Timepoint [1] 305929 0
This outcome will be measured at the following timepoints,
1. at baseline assessment
2. at 2 weeks after completion of the first two-week exercise intervention - primary timepoint
3. at 4 weeks after completion of the second two-week intervention
4. at 8 weeks, four weeks after completion of all interventions
Primary outcome [2] 305930 0
Plantarflexor power in a non-weightbearing position
a. Plantarflexion power will be measured using a hand-held dynamometer
b. Participants will lie on a plinth and the researcher will hold the hand-held dynamometer on the ball of the foot and give the instruction “try to point your toe as fast and strongly as you can”.
c. Three trials will be recorded, with the time to maximum force recorded
Timepoint [2] 305930 0
This outcome will be measured at the following timepoints:
1. at baseline assessment
2. at 2 weeks after completion of the first two-week exercise intervention - primary timepoint
3. at 4 weeks after completion of the second two-week intervention
4. at 8 weeks, four weeks after completion of all interventions
Primary outcome [3] 305933 0
Walking endurance
a. Measured using the six minute walk test
b. Participants will be asked to walk as many laps of the gym as possible in six minutes, with rests allowed whenever required.
c. The total distance walked and number of rests will be recorded.
Timepoint [3] 305933 0
This outcome will be measured at the following timepoints:
1. at baseline assessment
2. at 2 weeks after completion of the first two-week exercise intervention - primary timepoint
3. at 4 weeks after completion of the second two-week intervention
4. at 8 weeks, four weeks after completion of all interventions
Secondary outcome [1] 347056 0
plantar flexor power during a vertical jump from standing
a. Vertical jump will be measured using the Vertec system. The system consists of an upright pole with moveable plastic strips on the top. In standing, the participants is asked to reach as high as they can and the level reached is recorded. Then the subject is asked to perform a vertical jump, to reach as high as possible. The vertical jump is the difference in cms between the standing and jumping heights.
b. The participant’s legs will also be videotaped during the jump using MyJump software on an iPhone or iPad. This software calculates the distance jumped from the difference between two frames in the video. This additional data collection method will be used to confirm the results from the vertic system
Timepoint [1] 347056 0
This outcome will be measured at the following timepoints:
1. at baseline assessment
2. at 2 weeks after completion of the first two-week exercise intervention
3. at 4 weeks after completion of the second two-week intervention
4. at 8 weeks, four weeks after completion of all interventions
Secondary outcome [2] 347058 0
Lower leg plantartflexor strength
a. Plantarflexion strength will be measured using a hand-held dynamometer
b. Participants will be lying on a plinth and the researcher will hold the hand-held dynamometer on the ball of the foot and give the instruction “try to point your toe as fast and strongly as you can”.
c. Three trials will be recorded, with kgs of force recorded
Timepoint [2] 347058 0
This outcome will be measured at the following timepoints:
1. at baseline assessment
2. at 2 weeks after completion of the first two-week exercise intervention
3. at 4 weeks after completion of the second two-week intervention
4. at 8 weeks, four weeks after completion of all interventions
Secondary outcome [3] 347059 0
Patient's perception of pain / muscle soreness during the exercise program
Participants will record their level of pain on a VAS scale from 0 (no pain) to 10 (worst possible pain)

Timepoint [3] 347059 0
This outcome measure will be collected
1. 10 minutes before and 10 minutes after each of the eight exercise classes
Secondary outcome [4] 348212 0
Balance confidence
a. Balance confidence will be measured using the ABC6 - the short form of the Activities Balance Confidence scale
b. This short scale of 6 questions asks participants to rate their confidence that they won’t lose balance while doing different daily tasks eg walking on a rainy footpath
Timepoint [4] 348212 0
This outcome will be measured at the following timepoints:
1. at baseline assessment
2. at 2 weeks after completion of the first two-week exercise intervention
3. at 4 weeks after completion of the second two-week intervention
4. at 8 weeks, four weeks after completion of all interventions
Secondary outcome [5] 348213 0
Acceptability of training programs
a. This short series of questions asks participants to rate their perceptions of whether they think that the exercise programs will be beneficial or enjoyable.
b. responses are scored on a 5 point Likert scale where 1 = strongly agree, 2 = agree, 3 = neither, 4 = disagree or 5 = strongly disagree.
Timepoint [5] 348213 0
Participants will score the questions at the following timepoints:
1. before commencing the two weeks of the aquatic exercise program
2. at completion of the two weeks of the aquatic exercise program
3. before commencing the two weeks of the land-based exercise program
4. at completion of the two weeks of the land-based exercise program

Eligibility
Key inclusion criteria
• First time stroke occurred > 3 months prior to enrolment in study
• Community ambulant and able to walk no assistance or with a single stick for 10m
• Deemed medically stable by a general practitioner
• Ability to follow verbal commands
• No significant musculoskeletal impairment that restricts their mobility
• Not currnetly receiving active therapy for gait and mobility post stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cognitive impairments (Mini-Cog <3)
• Unstable cardiovascular status or general practictioner doesn't consider the person medically well enough to participate
• Additional neurological or orthopaedic disease causing mobility deficits
• Uncontrolled faecal incontinence
• Contagious diseases that contraindicate aquatic exercise eg. acute gastro-intestinal disease such as Noro Virus
• Open/infected wounds that are unable to be covered with a dressing

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification will be undertaken based on gender to ensure equalily of genders between the two treatment groups. Simple randomisation after stratification for gender will be undertaken using a randomisation table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be presented descriptively with values expressed in standard deviations, means and confidence intervals. Differences within groups (ie. pre to post) will be determined by paired-sample T test. Differences between groups will be determined by independent T-tests. Statistical significance will be set at p<0.05, with adjustment for mulitple comparisons as needed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/07/2018
Date of last participant enrolment
Anticipated
27/08/2018
Actual
Date of last data collection
Anticipated
5/11/2018
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22698 0
4014 - Banyo
Recruitment postcode(s) [2] 22699 0
4110 - Acacia Ridge

Funding & Sponsors
Funding source category [1] 298961 0
University
Name [1] 298961 0
Australian Catholic University
Country [1] 298961 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
School of Physiotherapy
Australian Catholic University
McAuley at Banyo Campus
1100 Nudgee Road
Banyo, Qld 4014
Country
Australia
Secondary sponsor category [1] 298177 0
None
Name [1] 298177 0
Address [1] 298177 0
Country [1] 298177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299895 0
Australian Catholic University HREC
Ethics committee address [1] 299895 0
Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 299895 0
Australia
Date submitted for ethics approval [1] 299895 0
18/01/2018
Approval date [1] 299895 0
17/05/2018
Ethics approval number [1] 299895 0
2018-8H

Summary
Brief summary
Stroke survivors often have difficulty walking quickly and this can limit their ability to walk at home and in the community. Exercises to train power in the leg muscles, plyometric exercises, have been shown to improve the speed of walking in younger and healthy older people. These exercises can be undertaken on land or in the pool, but stroke survivors may find the exercises easier in the pool. This pilot trial will therefore investigate whether aquatic plyometric exercises are as effective as land-based plyometric exercises to improving walking speed, endurance and leg power in stroke survivors.
Hypotheses:
• It is hypothesised that aquatic plyometric exercise will be equally effective as land-based plyometric exercise in improving gait speed, endurance and plantar flexor power in people with chronic stroke.
• It is hypothesised that land-based plyometric exercise will result in greater heart rate and blood pressure changes than aquatic plyometric exercise

The trial will aim to recruit twenty stroke survivors who have suffered a stroke more than three months ago, are living at home and can walk at least 10m independently or only need a walking stick. The trial will be a cross-over design, with participants randomly assigned into one of two groups. One group will start with twice a week aquatic exercise for two weeks, while the other group will start with twice a week land-based exercises. After two weeks, the groups will swap over with the aquatic group completing the land exercises and the second group completing the exercises in the pool.
A range of functional assessments will be completed. Walking speed will be measured on a ten metre walking track. Endurance will be measured by the distance participants can walk in six minutes. Lower leg power and strength will be recorded using a small, hand-held device which measures how much force is used to push into the device's force plate. Leg power will also be measured by seeing how high participants can reach when jumping from a standing position. In addition, measures of heart rate, blood pressure and muscle soreness will be recorded before and after each of the exercise sessions. Functional assessments will be completed before starting the exercise programs, after two weeks before swapping to the other exercise modality, after finishing the final exercise program and four weeks after completing the exercise protocols.
Statistical analysis will be used to compare differences between the two exercise programs and groups of participants to see whether the exercise programs increased walking speed, endurance and leg power in stroke survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81902 0
Dr Ann Rahmann
Address 81902 0
School of Physiotherapy
Australian Catholic University
McAuley at Banyo Campus
1100 Nudgee Road
Banyo Qld 4014
Country 81902 0
Australia
Phone 81902 0
+61 7 3623 7754
Fax 81902 0
+61 7 3623 7650
Email 81902 0
[email protected]
Contact person for public queries
Name 81903 0
Dr Ann Rahmann
Address 81903 0
School of Physiotherapy
Australian Catholic University
McAuley at Banyo Campus
1100 Nudgee Road
Banyo Qld 4014
Country 81903 0
Australia
Phone 81903 0
+61 7 3623 7754
Fax 81903 0
+61 7 3623 7650
Email 81903 0
[email protected]
Contact person for scientific queries
Name 81904 0
Dr Ann Rahmann
Address 81904 0
School of Physiotherapy
Australian Catholic University
McAuley at Banyo Campus
1100 Nudgee Road
Banyo Qld 4014
Country 81904 0
Australia
Phone 81904 0
+61 7 3623 7754
Fax 81904 0
+61 7 3623 7650
Email 81904 0
[email protected]

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Updated to:
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23614Study protocol-999999  

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