Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001574730
Ethics application status
Approved
Date submitted
13/12/2022
Date registered
20/12/2022
Date last updated
16/02/2024
Date data sharing statement initially provided
20/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute Effects of Resistance Training with Cluster Sets in Adults with Charcot-Marie-Tooth Disease
Scientific title
Acute Effects of Resistance Training with Intra-Set Rest on Physiological and Psychological Responses in Adults with Charcot-Marie-Tooth Disease
Secondary ID [1] 308619 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Charcot-Marie-Tooth Disease 328508 0
Fatigue 328509 0
Reduced physical function 328510 0
Condition category
Condition code
Neurological 325536 325536 0 0
Neurodegenerative diseases
Musculoskeletal 325547 325547 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental session will be conducted in an exercise clinic at the University of Sydney Camperdown campus (Susan Wakil Health Building). Specifically, the experimental sessions will involve a 5-minute warm-up followed by 30 minutes spent performing the exercises (inclusive of resistance exercise and recovery times). All sessions will be supervised by an exercise physiologist or exercise scientist with one-on-one supervision provided to participants. There will be 7 days between the two experimental sessions (i.e., wash-out). Familiarisation will be conducted at end of an initial testing visit and will involve performing 2 sets of the chest press and the leg press following the exercise prescription used for the ISR condition (details described below).

The intra-set recovery (ISR) condition will involve 4 sets of 2 clusters of 5 repetitions at 70% one-repetition maximum (1RM) with 30 seconds of rest between clusters and 90 seconds of rest between sets. Participants will perform the chest press prior to the leg press (in this order). The warm-up during experimental sessions will involve completing 1 set of 8 repetitions for the exercises performed in the session (i.e., chest press or leg press) with a load equivalent to 40% of 1RM. After 2 minutes of rest following the warm-up, participants will commence the first set of the experimental condition. The Keiser A420 pneumatic (air resistance) equipment (Fresno, CA, USA) will be used for the chest press and leg press.

Participants will be instructed to refrain from moderate-vigorous exercise and any activities outside of daily living for the previous 72 hours prior to each session. Participants will also be asked not to start any other new exercise regimen or intentionally change their habitual diet throughout the entire study and assessment.
Intervention code [1] 325065 0
Treatment: Other
Intervention code [2] 325084 0
Rehabilitation
Comparator / control treatment
The experimental session will be conducted in an exercise clinic at the University of Sydney Camperdown campus (Susan Wakil Health Building). Specifically, the experimental sessions will involve a 5-minute warm-up followed by 30 minutes spent performing the exercises (inclusive of resistance exercise and recovery times). All sessions will be supervised by an exercise physiologist or exercise scientist with one-on-one supervision provided to participants. There will be 7 days between the two experimental sessions (i.e., wash-out). Familiarisation will be conducted at end of an initial testing visit and will involve performing 2 sets of the chest press and the leg press following the exercise prescription used for the traditional (TRAD) condition (details described below).

The TRAD condition will involve 4 sets of 10 repetitions at 70% 1RM with 120 seconds of rest between sets. Participants will perform the chest press prior to the leg press (in this order). The warm-up during experimental sessions will involve completing 1 set of 8 repetitions for the exercises performed in the session (i.e., chest press or leg press) with a load equivalent to 40% of 1RM. After 2 minutes of rest following the warm-up, participants will commence the first set of the experimental condition. The Keiser A420 pneumatic (air resistance) equipment (Fresno, CA, USA) will be used for the chest press and leg press.

Participants will be instructed to refrain from moderate-vigorous exercise and any activities outside of daily living for the previous 72 hours prior to each session. Participants will also be asked not to start any other new exercise regimen or intentionally change their habitual diet throughout the entire study and assessment.
Control group
Active

Outcomes
Primary outcome [1] 333374 0
Muscle force assessed by Keiser pneumatic equipment.
Timepoint [1] 333374 0
Monitored continuously throughout resistance exercise.
Primary outcome [2] 333376 0
Muscle power output assessed by Keiser pneumatic equipment.
Timepoint [2] 333376 0
Monitored continuously throughout resistance exercise.
Primary outcome [3] 333392 0
Velocity assessed by Keiser pneumatic equipment.
Timepoint [3] 333392 0
Monitored continuously throughout resistance exercise.
Secondary outcome [1] 416833 0
Muscle oxygenation assessed by near-infrared spectroscopy (NIRS).
Timepoint [1] 416833 0
Monitored continuously for the duration of each exercise session, and immediately post-exercise.
Secondary outcome [2] 416834 0
Muscle activation assessed by electromyography (EMG).
Timepoint [2] 416834 0
Monitored continuously for the duration of each exercise session.
Secondary outcome [3] 416835 0
Perceptual fatigue assessed using the Visual Analog Fatigue Scale (VAFS).
Timepoint [3] 416835 0
Immediately post-exercise.
Secondary outcome [4] 416836 0
Muscle soreness assessed by a visual analog scale with scores ranging from 0 to 100 measured in millimetres on a 10-cm vertical line using a pen.
Timepoint [4] 416836 0
Assessed 7 days post-exercise session.
Secondary outcome [5] 416878 0
Feeling responses assessed via the Feeling Scale (5-point Likert scale).
Timepoint [5] 416878 0
Immediately pre-exercise and immediately post-exercise.
Secondary outcome [6] 416879 0
Blood flow assessed by near-infrared spectroscopy (NIRS).
Timepoint [6] 416879 0
Monitored continuously for the duration of each exercise session, and immediately post-exercise.
Secondary outcome [7] 416970 0
Arousal response assessed by Felt Arousal Scale (6-point Likert scale).
Timepoint [7] 416970 0
Immediately pre-exercise and immediately post-exercise.
Secondary outcome [8] 416971 0
Momentary activation assessed by Activation Deactivation Adjective Check List (4-point Likert scale).
Timepoint [8] 416971 0
Immediately pre-exercise and immediately post-exercise.
Secondary outcome [9] 416972 0
Mood assessed by Mood Survey Scale (5-point Likert scale).
Timepoint [9] 416972 0
Immediately pre-exercise and immediately post-exercise.

Eligibility
Key inclusion criteria
To be included in this study individuals need to be clinically diagnosed with Charcot-Marie-Tooth disease (CMT) based on genetic and electrophysiological data. Participants need to be free of rotator cuff tear or history of any shoulder or back or lower extremity condition, injuries, surgeries, congenital malformations, back, knee, or hip osteoarthritis, recent fracture (12 months), cognitive impairment as defined by Montreal Cognitive Assessment score of 27-30, acute or terminal illness and any unstable or ongoing cardiovascular/respiratory disorders.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with morbid obesity (BMI > 40) will also be excluded since thick subcutaneous fat might impair NIRS outcomes. Participants that cannot speak English. People will be excluded if they are not sufficiently ambulatory (defined as the inability to walk 100 m in under 4 minutes).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will find out the order of the experimental protocols which will be determined by permuted block randomization (www.random.org).
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
Descriptive statistics will be calculated for mean power output, total power output, and velocity loss. The normality of the absolute data will be investigated using the Shapiro–Wilk test, and Levene’s test will be used to assess the homogeneity of variance. For normally distributed data, means ± standard deviation (SD) and confidence interval (95% CI) will be reported. For non-normally distributed data median and interquartile ranges will be reported. Conditions will be analyzed with a two-way analysis of variance (ANOVA) with repeated measures for normally distributed data and an appropriate non-parametric test for non-normally distributed data. The statistical tests will examine the differences in power maintenance (mean power output, total power output, and velocity loss) and muscle oxygenation (expressed as % tissue saturation index) in protocols.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2023
Actual
13/09/2023
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
30
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312858 0
Charities/Societies/Foundations
Name [1] 312858 0
CMT Australia: Charcot-Marie-Tooth Australia Inc.
Country [1] 312858 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science.
Level 6, Western Avenue, D18 - Susan Wakil Health Building, Camperdown, NSW, 2006.
Country
Australia
Secondary sponsor category [1] 314512 0
None
Name [1] 314512 0
Address [1] 314512 0
Country [1] 314512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312136 0
The University of Sydney Human Research Ethics Committe (HREC)
Ethics committee address [1] 312136 0
Ethics committee country [1] 312136 0
Australia
Date submitted for ethics approval [1] 312136 0
14/12/2022
Approval date [1] 312136 0
28/06/2023
Ethics approval number [1] 312136 0
Approval number: 2023/323

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123606 0
Dr Daniel Hackett
Address 123606 0
The University of Sydney
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science.
Level 6, Western Avenue, D18 - Susan Wakil Health Building, Camperdown, NSW, 2006
Country 123606 0
Australia
Phone 123606 0
+61 424133724
Fax 123606 0
Email 123606 0
[email protected]
Contact person for public queries
Name 123607 0
Daniel Hackett
Address 123607 0
The University of Sydney
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science.
Level 6, Western Avenue, D18 - Susan Wakil Health Building, Camperdown, NSW, 2006
Country 123607 0
Australia
Phone 123607 0
+61 424133724
Fax 123607 0
Email 123607 0
[email protected]
Contact person for scientific queries
Name 123608 0
Daniel Hackett
Address 123608 0
The University of Sydney
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science.
Level 6, Western Avenue, D18 - Susan Wakil Health Building, Camperdown, NSW, 2006
Country 123608 0
Australia
Phone 123608 0
+61 424133724
Fax 123608 0
Email 123608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Available for 5 years after publication (Starting on 1st December 2024 and ending on 30th November 2029).
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access is subject to approvals by Principal Investigator (Dr Daniel Hackett) [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17858Ethical approval    Will be available via an attachment.



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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