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The Effects of a 16-week Aerobic Exercise and Mindfulness-based Intervention on Chronic Psychosocial Stress: A Nonrandomized Pilot and Feasibility Trial

The Effects of a 16-week Aerobic Exercise and Mindfulness-based Intervention on Chronic Psychosocial Stress in a Non-clinical Sample of Healthy Adults: A Nonrandomized Pilot and Feasibility Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001726145
Enrollment
17
Registered
2019-12-09
Start date
2016-07-04
Completion date
2017-04-03
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Researchers have begun delivering mindfulness and aerobic exercise training concurrently on the premise that a combination intervention will yield salutary outcomes over and above each intervention alone. An estimate of the effect of combination training on chronic psychosocial stress in a nonclinical population has not been established. The objective of this trial was therefore to assess the preliminary efficacy of combination training for reducing chronic psychosocial stress in a healthy sample, and to establish assurance of protocol feasibility in preparation of a definitive RCT. This trial was designed as a prevention-focused (i.e., primary) intervention to be used by all individuals and not just those presenting with mental health risk factors.

Interventions

Intervention Overview This nonrandomized pilot and feasibility trial was conducted as a single-arm trial where all participants were subjected to 16 weeks of aerobic exercise and mindfulness-based training, delivered concurrently. This trial was conducted across two waves: wave 1 (August to November 2016) and wave 2 (April to July 2017). Recruitment was conducted across a one-month time period prior to the trial period of each wave. Pre-test (T0) and post-test (T1) measures were obtained 1 to 4

Intervention Overview This nonrandomized pilot and feasibility trial was conducted as a single-arm trial where all participants were subjected to 16 weeks of aerobic exercise and mindfulness-based training, delivered concurrently. This trial was conducted across two waves: wave 1 (August to November 2016) and wave 2 (April to July 2017). Recruitment was conducted across a one-month time period prior to the trial period of each wave. Pre-test (T0) and post-test (T1) measures were obtained 1 to 4 weeks prior to and after the trial period. As participants were predominantly postgraduate and undergraduate students from a variety of disciplines, these periods were selected to correspond to 'low-stress' periods in the academic calendar (i.e., pre- or -post semester). Participant compliance to the intervention was encouraged in weekly meeting sessions and via weekly email progress reports. Mindfulness-based Intervention (MBI) The MBI was an adaptation of the mindfulness-based Stress Release Program (SRP): a stress management and cognitive therapy program that uses mindfulness practices to raise awareness of the processes underlying stress and negative emotions. The training approach can be summarized in two modules that align with the monitor and acceptance theory (MAT) of mindfulness meditation. This includes: (1) attention monitoring, and (2) acceptance. One instructor who had received direct training from the original facilitators of SRP delivered the intervention. Attention monitoring: The goal of the attention monitoring module was to systematically train participants to improve their ability to observe present-moment experiences through formal meditation practices. The formal practice of meditation involved activities that required sustained focused-attention meditation towards a focus object (i.e., breath, body, sound, or thoughts). The formal practice prescription comprised up to 20 min of focused-attention meditation, daily, over 16 weeks. Completion of this daily target was at the discretion of participants. Formal practice was conducted in a group setting in a seminar room located at Monash University during the weekly training session, and participants were provided with audio recordings containing spoken instructions (Monash University Counselling Services) to guide home practice. To guide progress and track compliance, participants were further instructed to record their formal practice in an online spreadsheet (Google Sheets, Google, US). Formal practice was reported each day as minutes of formal meditation practice. This was converted to hours, and total hours of meditation for each participant across the intervention was recorded as the formal practice dosage. Adherence requirements for the attention monitoring module were completion of at least 50% of the target formal meditation (target = 37.34 h [20 min/day over 16-weeks]; minimum adherence requirement = 18.67 h). Acceptance: The goal of the acceptance module was to foster a mental attitude of acceptance towards negative and stress-laden experiences. This included: (1) a willingness to allow negative experiences to rise and pass, and to let go of thoughts, ideas, or desires that may be associated with the experience (non-attachment), (2) a willingness to be available to negative experiences without attempting to suppress or avoid them (non-avoidance), and (3) a conscious abstention for categorizing an experience as good or bad, or right or wrong (non-judgment). These skills were trained over eight weekly group training sessions and discussion activities (50 min), and homework tasks (completed at discretion of participants) that encouraged participants to reflect on stress-laden or negative experiences with an attitude of acceptance. Adherence requirements for the acceptance module were that participants attend at least 50% of the group psychoeducation sessions, with compliance monitored through attendance records. Aerobic exercise training intervention (AET) The AET program comprised endurance running as part of a half-marathon training program. The AET prescription was three runs per week over 16 weeks (one group session and two self-guided sessions). This included: (1) a 5 min warm up, then an interval run that involved 200 m bursts of near-maximal intensity followed by a 200 m recovery to the total of 16 min, then a 5 min cool down, (2) a short run of moderate or moderate-to-vigorous intensity that gradually increased in duration from 20 min to 60 min over 16 weeks, and (3) a long run at a moderate intensity or moderate-to-vigorous intensity that gradually increased in duration from 20 min to 110 min over 16 weeks. Additionally, participants completed three distance running trials at a moderate or moderate-to-vigorous intensity (Week 6 = 10 km, Week 9 = 10 km, Week 12 = 15 km). Exercise intensity categories were formally defined by the ACSM exercise prescription guidelines: (1) moderate intensity = 46 to less than 64% VO2max, (2) vigorous intensity = 64 to less than 91% VO2max, and (3) near-maximal intensity = greater than or equal to 91% VO2max. Running velocity corresponding to these intensity categories were individually prescribed to each participant by plotting oxygen consumption (VO2 mL/kg/min) against running velocity (km/h) in a regression model derived from a baseline VO2max test. In this way, exercise intensity was completely individualized. In addition to the AET, participants were asked to maintain their regular pattern of physical activity outside of the intervention (e.g., gym, leisure activities, and cycling commutes). To guide performance and track compliance, participants were issued a computerized and GPS-enabled sportswatch (Garmin Forerunner 235, Garmin, US). This device provided participants real-time estimates of running velocity, and therefore of individual exercise intensity. Participants uploaded their running data to an online database weekly, which provided detailed information on training velocity, distance, and time. Adherence requirements for the AET program were completion of at least 50% of all prescribed runs (target = 48 individual runs [3 runs/week over 16 weeks]; minimum adherence requirement = 24 runs). Average % VO2max across all running sessions, total running distance (km), and total running time (h) were also recorded as measures of dosage.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

No engagement in regular running training or meditation practice within six months prior to first assessment.

Exclusion criteria

(1) age not within 18 - 35 years. (2) prior completion of an endurance event equivalent to a half-marathon (21.1 km). (3) prior completion of a formal meditation program. (4) current diagnosis of a neurological or mental disorder. (5) current diagnosis/history of chronic pain or musculoskeletal conditions. (6) current diagnosis/history of chronic disease of any kind. (7) current diagnosis of a heat or cold disorder. (8) current use of medication that influences the neuroendocrine or immune system. (9) current injury of any kind (e.g., joint or muscle injury). (10) current diagnosis of an infectious disease. (11) BMI >= 30 kg/m2. (12) pregnancy or suspected pregnancy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026