Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000837426
Ethics application status
Approved
Date submitted
3/07/2025
Date registered
5/08/2025
Date last updated
5/08/2025
Date data sharing statement initially provided
5/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
To assess the feasibility of stretching and education for night-time calf muscle cramps: a randomised feasibility trial
Scientific title
To assess the feasibility of conducting a fully powered randomised controlled trial to evaluate the effectiveness of a multimodal lower limb cramps prevention intervention comprising of lower limb stretching and cramps prevention education in adults without known neurological disease who get night-time calf cramps at least twice per week.
Secondary ID [1] 314746 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle cramps 337960 0
Condition category
Condition code
Musculoskeletal 334278 334278 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will recruit 40 adults who experience night-time calf muscle cramp at least twice per week and who do not have known neurological disease. Twenty people will be randomly assigned to a combination of calf and hamstring stretching plus receive cramps-prevention education. The stretching group will be shown how to perform hamstring/calf stretches. Participants will be asked to perform stretches twice per day; once before bed and once again throughout the day at a time of their choosing. Participants will stretch both legs, one at a time. Each stretch will be held for 1 min and repeated once in each stretching session (a total of 4 minutes stretching each stretching session).

Participants will receive education about what cramps are and will be encouraged to keep the lower limbs warm at night. Participants will be told that this could be achieved by wearing long pyjama pants, wool socks tucked into pyjama pants and potentially wool leg warmers pulled up over their knees. Participants will be told that in order to keep lower extremities warm, the core body temperature must also be warm, so to use adequate bedding on cool nights. Participants will also be encouraged to avoid days of very high and very low activity, and to instead aim for a fairly consistent amount of moderate exercise each day. They will also be told that, if they notice muscle twitching in the calf muscle, stretch the muscle by straightening the knee and moving the toes towards the shin. They will also be advised to sleep, when comfortable, with calf muscle on slight stretch by tucking the toes up towards the shins – either by resting the bottom of the toes against the bedding (if lying on back) or on the bed (if lying on stomach). They will also be told that, when waking in the morning, if inclined to stretch the legs, to do so by straightening the knee and moving the toes towards the shin. Participants will be educated to avoid pointing the toes whilst performing the above stretch. This information will be delivered once, face to face by lead researcher (EC) at week 0 appointment and will also be available in written form in the front page of stretching handbook provided.

Participants will log stretching adherence in stretching handbook provided and also encouraged to complete stretching and log stretching via phone calls made by lead researcher (EC) during the trial period.

Total duration of the intervention is 6 weeks.
Adherence will be logged in a handbook provided.
Intervention code [1] 331350 0
Prevention
Intervention code [2] 331486 0
Treatment: Other
Comparator / control treatment
Twenty people will be randomly assigned to sham stretching and cramps education (no cramps prevention education). This group will receive sham exercises devised to be of comparable body position, simplicity and duration to the intervention stretching, but involve negligible stretching of calf and hamstring muscles. Participants will be asked to perform stretches twice per day; once before bed and once again throughout the day at a time of their choosing. Participants will stretch both legs, one at a time. Each stretch will be held for 1 min and repeated once in each stretching session (a total of 4 minutes stretching each stretching session)
Control group
Placebo

Outcomes
Primary outcome [1] 342009 0
The primary outcome of the study is to determine the feasibility of conducting a full-scale RCT.
Timepoint [1] 342009 0
Baseline (week 0) and completion of the intervention (week 6 post-baseline).
Primary outcome [2] 342193 0
Demand: On average, equal to 2 participants recruited per week in the first 8 weeks recruitment
Timepoint [2] 342193 0
Baseline (week 0) and 8 weeks post-baseline
Primary outcome [3] 342194 0
Implementation: less than 50% of potential participants excluded prior to randomisation due to recording less than 2 cramps per week in the initial 2 week observation period.
Timepoint [3] 342194 0
Daily record from week -2 (2 weeks prior to enrolment, screening period) until week 0 (time of enrolment, baseline)
Secondary outcome [1] 449295 0
Change in cramp frequency and time of onset assessed as a composite outcome.
Timepoint [1] 449295 0
Daily record from week -2 (2 weeks prior to enrolment, screening period) and at completion of the intervention (week 6 post-enrolment). Assessed for 8 weeks in total.
Secondary outcome [2] 449297 0
Change in cramp pain severity
Timepoint [2] 449297 0
Daily record from baseline (week 0) until completion of the intervention (week 6 post-baseline)
Secondary outcome [3] 449896 0
Change in quality of sleep
Timepoint [3] 449896 0
Baseline (week 0) and at completion of the intervention (week 6 post-baseline)
Secondary outcome [4] 449897 0
Change in health-related quality of life
Timepoint [4] 449897 0
Baseline (week 0) and completion of the intervention (week 6 post-baseline)
Secondary outcome [5] 449912 0
Change in participant stretching adherence. Greater than or equal to 60% of participants recording completing stretches at least once on most days of the 6 week intervention period.
Timepoint [5] 449912 0
Daily record from baseline (week 0) until completion of the intervention (week 6 post-baseline).
Secondary outcome [6] 449913 0
Change in participant numbers from baseline to week 6 of trial period (drop rate of less than or equal to 20%).
Timepoint [6] 449913 0
Baseline (week 0) and at completion of the intervention (week 6 post-baseline).
Secondary outcome [7] 449915 0
Change in adverse events such as muscle strain or tears, or tendon tears, pinching of nerves, and joint injury between groups.
Timepoint [7] 449915 0
Completion of intervention (week 6 post-baseline).

Eligibility
Key inclusion criteria
Age 18 years and older
People experiencing night-time calf cramps at least twice per week. Frequency of cramps will be recorded for 2 weeks prior to enrolment and receiving group allocation. Muscle cramps will be defined as a sudden, involuntary and painful contraction of muscle that gradually lessens. During cramp, the affected muscle hardens and joints can be forced into unusual positions. In some people, cramp can be brought on by certain movements and/or stopped by stretching the muscle.
During the first phone conversation and reiterated in person before enrolling, Erin Croft will attempt to differentiate cramp from other foot and leg problems that occur at night, for example:
• Muscle cramp is different to restless leg syndrome, in which people experience an urge to move their legs. Restless leg syndrome is not very painful and does not involve hardening of the muscle.
• Muscle cramp is different to ‘ischaemic rest pains’ that occur directly because of low blood flow while lying down, in which a general ache occurs and muscles do not harden and joints to not move. Both cramp and ‘rest pain’ may be relieved by standing.
• Muscle cramp is different to hypnagogic jerks, in which people experience sudden but not painful jerking of the leg while falling to sleep.

Ambulant
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Conditions known to cause cramps (neuromuscular or neurological disease, pregnancy; and haemodialysis).
People diagnosed with diabetes, as diabetes commonly impairs nerve function
Lower limb amputation except for digit amputation
Lower back pain that lasted for longer than a day in the last 3 months
Sciatica
Hip or knee replacements in the last 6 months
Non-skin lower limb malignancy
Current lower limb soft tissue or bone infection
Current lower limb fracture
Unable to perform stretches of the lower limbs while holding a stretching towel with their upper limbs.
Unable to write, read or comprehend English
Morbid obesity (BMI > 40)
Unwilling or unavailable to complete a 6 week stretching program, record cramps in a daily diary for 8 weeks (6 week trial period plus 2 weeks prior to trial), or attend 3 face-to-face appointments.
People directed by a medical doctor to rest in bed or have low levels of activity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation schedule will be created by a research team member not involved in recruitment, screening, or intervention. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes. As each participant enrols, the lead researcher will open the next envelope to reveal group allocation. Group allocation will not be shared with the participant. To reduce risk of a participant seeing their group allocation, groups will be colour coded – ie red group or blue group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation performed by research team member not involved in recruitment, screening or intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SF-36 data will be entered twice into Quality Metric Health OutcomesTM Scoring Software 3.0. Computed domain scores will be transferred to SPSS v. 19.0 (Chicago, Illinois) for statistical analyses and checked for transcription error. To ensure accuracy, MOS-SS domain scores will be calculated twice following scoring rules (Spritzer et al., 2003). MOS sleep scale: A manual for use and scoring, version 1.0. Los Angeles, CA. Descriptive statistics will be calculated to characterise the sample. Normality of distribution will be determined using Kolmogorov–Smirnov statistic and inspection of data distribution on histograms. Continuous data will be reported as means and standard deviations (SDs) or medians and interquartile ranges as appropriate. Feasibility outcomes of practicality, demand, acceptability, and implementation will be reported using descriptive statistics. Baseline and follow-up scores will be presented descriptively with unadjusted means and SDs. For the secondary aim of limited efficacy testing, we will analyse data according to intention-to-treat. That is, data will be analysed according to the groups to which participants were randomised, regardless of any deviations from the protocol, and in the event of missing data, we will use the last observation carried forward method to impute missing data.
Following this, for continuous data, ANCOVA will be fitted adjusting for age, sex, and baseline outcome score to ascertain differences between groups at follow-up.
We will perform sensitivity analysis to assess the robustness of our findings by repeating the analysis including data from only those participants who completed their cramps logbook in weeks 7 and 8 of the intervention period and completed the SF-36 and MOS-SS.
As cramp frequency data are rates (a type of count data of number of events per unit of time), we will select the appropriate statistical model according to the variance observed in the dataset. We will use Poisson Regression if counts are low and the variance is equal to the mean, nagtive binominal regression if variance is greater than the mean, or a zero-inflated model if there are excess zeros in the data. If parametric assumptions are not met, we will use an appropriate non-parametric method such as the van Elteren test of bootstrapping.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28159 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment postcode(s) [1] 44369 0
2299 - Lambton
Recruitment postcode(s) [2] 44370 0
2259 - Hamlyn Terrace

Funding & Sponsors
Funding source category [1] 319299 0
University
Name [1] 319299 0
University of Newcastle
Country [1] 319299 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 321773 0
None
Name [1] 321773 0
Address [1] 321773 0
Country [1] 321773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317877 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 317877 0
Ethics committee country [1] 317877 0
Australia
Date submitted for ethics approval [1] 317877 0
19/02/2025
Approval date [1] 317877 0
25/06/2025
Ethics approval number [1] 317877 0
H-2025-0105

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

Contacts
Principal investigator
Name 142438 0
Dr Fiona Hawke
Address 142438 0
10 Chittaway Rd, Ourimbah NSW 2258. School of Health Sciences, College of Health, Medicine and Wellbeing MP214 Ourimbah Campus, The University of Newcastle
Country 142438 0
Australia
Phone 142438 0
+61 02 4349 4549
Fax 142438 0
Email 142438 0
[email protected]
Contact person for public queries
Name 142439 0
Fiona Hawke
Address 142439 0
10 Chittaway Rd, Ourimbah NSW 2258. School of Health Sciences, College of Health, Medicine and Wellbeing MP214 Ourimbah Campus, The University of Newcastle
Country 142439 0
Australia
Phone 142439 0
+61 02 4349 4549
Fax 142439 0
Email 142439 0
[email protected]
Contact person for scientific queries
Name 142440 0
Fiona Hawke
Address 142440 0
10 Chittaway Rd, Ourimbah NSW 2258. School of Health Sciences, College of Health, Medicine and Wellbeing MP214 Ourimbah Campus, The University of Newcastle
Country 142440 0
Australia
Phone 142440 0
+61 02 4349 4549
Fax 142440 0
Email 142440 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Dr Fiona Hawke
School of Health Sciences, College of Health, Medicine and Wellbeing
University of Newcastle
Email: [email protected]


Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.