Actigraphy

Jonathan Greenberg et al. (2025) · JAMA network open

This feasibility randomized clinical trial with 92 sedentary adults experiencing chronic musculoskeletal pain explored whether a mind-body walking program could be delivered successfully across three geographically and racially diverse U.S. academic medical centers, compared with a health education program. The mind-body walking program combined quota-based pacing — increasing step-count goals gradually based on what participants could sustain, rather than tying goals to whether pain was present — with mind-body skills such as breathing exercises and body scans, and cognitive skills aimed at identifying and reframing unhelpful pain-related thoughts. The trial measured physical function in three complementary ways (self-reported, performance-based, and step-count-based), addressing a gap identified in pain-trial reporting guidelines. Participants were randomized 1:1 to the 10-week, 60-minute weekly group mind-body walking program (47 participants) or a matched health-education control (45 participants), recruited between April 2023 and January 2024. The mind-body group received a Fitbit Inspire 3 tracker with individualized weekly step goals. Physical function was measured with the 6-Minute Walk Test, a wrist-worn accelerometer worn for one week, and the World Health Organization Disability Assessment Schedule. Pain, mood, and psychological mechanisms — pain catastrophizing, fear of movement, adaptive coping, and mindfulness — were measured with validated questionnaires before and after the program. Both programs met most feasibility benchmarks, including attendance (95.7% mind-body walking vs 82.2% health education), delivery fidelity, and participant retention (93.6% vs 86.7%). Racial and ethnic diversity exceeded its target (54.3% of participants from minority groups, against a 38% benchmark), though overall recruitment fell short (69.7% of eligible patients enrolled, against an 80% target). Within the mind-body walking group, participants showed large pre-to-post improvements in walking distance (48.6 meters over six minutes, P<.001), self-reported physical function (P<.001), and pain catastrophizing (P<.001), plus medium improvements in pain intensity (P=.002) and fear of movement (P<.001), and smaller but significant improvements in adaptive coping and mindfulness (both P<.05). The health education group improved only on walking distance and pain intensity. Because the trial was not statistically powered to compare the two programs against each other, these within-group changes describe what happened in each arm rather than a demonstrated advantage of one program over the other. The trial establishes that a mind-body walking program can be delivered with strong attendance and participant satisfaction across diverse academic medical centers, supporting a future, fully powered efficacy trial. The findings do not establish that the mind-body walking program produces greater benefit than health education, since the study was designed to test feasibility rather than comparative outcomes. The gap between eligible and enrolled participants (69.7% versus an 80% target) points to recruitment timing as an area for refinement in future trial designs.

Harshith Chandra Shekhar et al. (2023) · Advances in therapy

This double-blind randomized trial with 80 adults tested whether valerian — the root extract that has been Europe's traditional sleep herb for centuries — measurably improves sleep when held to modern trial standards. Participants with ongoing sleep complaints took either 200 mg of standardized Valeriana officinalis extract or an identical placebo capsule daily for eight weeks, with neither participants nor researchers knowing who received which. What sets this trial apart is how sleep was measured. Beyond the standard Pittsburgh Sleep Quality Index questionnaire, everyone wore wrist actigraphy devices that objectively track sleep and wake, and half the participants underwent polysomnography — the full laboratory sleep study with brain-wave monitoring that sleep medicine treats as its gold standard. Anxiety, daytime sleepiness, and the feeling of waking refreshed were tracked alongside, with blood work and vital signs monitoring safety throughout. Valerian delivered on nearly every front. Sleep quality scores improved significantly versus placebo by day 14 and stayed better through day 56 (p<0.05). The objective measures agreed: actigraphy showed people falling asleep faster and sleeping longer from day 3 onward, and the laboratory sleep studies confirmed longer total sleep, quicker sleep onset, and better sleep efficiency at eight weeks. Anxiety scores dropped, daytime drowsiness eased, and participants reported waking up more refreshed. No safety signals appeared in any blood test, vital sign, or examination — a meaningful contrast with prescription sleep aids and even melatonin's daytime-drowsiness complaints. This trial offers unusually convergent evidence for valerian in mild sleep complaints: subjective ratings, wrist-worn tracking, and laboratory measurement all pointed the same direction at a modest 200 mg daily dose. The caveats are a moderately sized sample of younger adults with mild symptoms and an eight-week window — the findings do not extend to severe or chronic insomnia.