Hallegraeff 2012

Methods	Randomised controlled trial of six weeks duration
Participants	Inclusion criteria: age over 55 years; and nocturnal leg cramps at least once per week Exclusion criteria: use of quinine or medication to assist with sleep; orthopaedic problems; severe medical conditions; or comorbidities known to cause muscular spasms or cramps Age, years, mean (SD): stretching 67(7); control 72(7) Sex, n, males (%): stretching 25 (50); control 26 (65)
Interventions	‘Participants in the experimental group attended a 45 minute visit at which they were taught a program of daily stretching exercises for the hamstring and calf muscles by one physiotherapist, who was specially trained in the study procedures… For each stretch, the participant was advised to adopt the position shown, move to the comfortable limit of motion, move beyond this until a moderately intense stretch was felt and sustained for 10 seconds, and then return to the starting position. Participants were instructed to remain calm and never to hold their breath during the stretch. Each stretch was performed a total of three times, with 10 seconds of relaxation between each stretch. Stretching of both legs was done within three minutes. The physiotherapist demonstrated the stretches first and then observed the participant performing the stretches, correcting the technique if necessary. If a participant found stretching while standing difficult, the participant was shown how to stretch in a sitting position.’ ‘Participants in the control group were advised not to stretch’. ‘The control group [members] were not taught any sham stretches and were advised not to commence stretches’. Instructions for all participants ‘Participants were strongly encouraged not to make any changes to their typical daily routine of work and leisure activity.’ ‘All participants were encouraged to maintain all other usual activity unchanged. At week 4, all participants received a home visit to assess and encourage adherence to the study protocol.’
Outcomes	Primary outcome: ‘change in the average number of nocturnal leg cramps per day over a one‐week period. This was assessed in the week prior to starting the 6‐week stretching program (Week 0) and again in the final week of the stretching program (Week 6).’ Secondary outcome: severity of nocturnal leg cramps, measured using ‘a 10 cm visual analogue scale with 0 cm representing no pain and 10 cm representing the worst pain the participant could imagine. Recordings were again made in the daily diary over the same 1‐week periods’. Adverse events: ‘ If adverse events were present, they were recorded daily in the diary card throughout the trial’.
Notes	Setting: Physical therapy clinic in Groningen, The Netherlands. Participants were recruited through advertisement in local newspapers in the northern part of the Netherlands. Funding source were not described.