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A pilot study on the effects of intermittent and graded exercise compared to no exercise for optimising health and reducing symptoms in Chronic Fatigue Syndrome (CFS)patients.

A pilot study on the effects of intermittent and graded exercise compared to no exercise for optimising health and reducing symptoms in Chronic Fatigue Syndrome (CFS)patients.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001241820
Enrollment
45
Registered
2012-11-23
Start date
2013-05-20
Completion date
2014-01-27
Last updated
2024-11-04

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

Conditions

None listed

Brief summary

This project will investigate the efficacy of intermittent or interval exercise training compared to graded exercise (steady state or constant load) for individuals with Chronic Fatigue Syndrome. Current evidence suggests that the graded exercise combined is beneficial for CFS, but there has been no research investigating intermittent exercise effects with CFS. Intermittent exercise has been shown to improve functional capacity with reduced perceived exertion and symptoms in individuals with cardiovascular and pulmonary disease, and it may be a more effective exercise strategy than graded exercise, as the exercise intervals are alternated with short periods of rest or very low intensity exercise. The project is a 12 week randomised controlled study, comparing intermittent, graded and control (usual care) groups. Efficacy of each type of delivery of exercise will be measured by outcomes such as aerobic capacity, exercise duration and tolerance, symptoms (pain and fatigue), perceived exertion, quality of life, immune cell counts and function, inflammatory cytokine responses, physiological adaptations and functional capacity for activities for daily living (ADL). Participants will exercise on a cycle ergometer in a supervised health clinic for three sessions per week. Outcome measures will be assessed pre- and post-training; resting and recovery heart rates, blood pressures and exercise Rate of Perceived Exertion (RPE) will be recorded at each exercise session. Participants will also keep an exercise and symptom diary to record muscle and general fatigue, weakness and pain (if any) on exercise and rest days. Data will be statistically analysed using ANOVA and Cohen’s Effect size (SPSS). The results will be applicable to CFS and other chronic disease-related fatigue sufferers (e.g. cancer and cardiac patients), and will contribute to further larger grant applications to NHMRC and ARC.

Interventions

Randomised controlled trial of intermittent exercise training compared to graded exercise and standard care. Graded exercise is the current recommended exercise approach to CFS and consists of self-paced (e.g. low intensity) steady state exercise at a constant workload for a short period of time; as the patient gradually improves their fitness, the length of time and eventually the intensity is increased in a gradual graded manner provided no adverse symptoms occur. Intermittent or interval exer

Randomised controlled trial of intermittent exercise training compared to graded exercise and standard care. Graded exercise is the current recommended exercise approach to CFS and consists of self-paced (e.g. low intensity) steady state exercise at a constant workload for a short period of time; as the patient gradually improves their fitness, the length of time and eventually the intensity is increased in a gradual graded manner provided no adverse symptoms occur. Intermittent or interval exercise consists of short blocks of exercise, at low-moderaste intensity with a rest interval in between bouts of exercise e.g. 1 min low intensity cycling, followed by 1 minute of rest, followed by 1 minute of cycling; the total time spent exercising can be gradually increased whilst maintaining the rest or unloaded exercise intervals. The participants will be randomly allocated to one of 3 groups. Each group will consist of 20 participants to provide a power of 80% for the study (based on data from Gordon et al., 2010), using an aprior test to compute required sample size, given alpha (p = 0.05), power and effect size for an F test, and looking at ANOVA fixed effects, main effects and interactions (GPower). Volunteers will participate in 3 aerobic exercise sessions (cycling on a cycle ergometer) per week, consisting of: (1) a warm up of 5 minutes of unloaded cycling for both ITE and GE groups; (2) either a steady state (constant effort) low-moderate intensity cycling period, (50% VO2peak, RPE 3 Modified Borg Scale) initially for 10 minutes (GE group) OR an intermittent exercise block of 1 minute of moderate intensity cycling (60% VO2peak, RPE 4-5) alternated with 1 minute of unloaded or very low intensity/unloaded cycling (20-30% VO2peak, RPE 1-2), totalling 20 minutes; (3) cool down of 5 minutes unloaded cycling plus stretching of main muscle groups for both groups. Over the 12 weeks of the project, we aim to progress the duration of SS exercise towards 20 min, as tolerated by the participant, and to progress the ITE participants towards intervals of 2-3 min of moderate intensity cycling, alternated with 1 minute intervals of low intensity cycling, totalling 25-30 min duration. All group sessions will be supervised by one of the research team (who are accredited exercise physiologists) with assistance from post-graduate Masters of Clinical Exercise Physiology students, who are studying to become accredited exercise physiologists. The total intervention duration will be 12 weeks for graded, intermittent and control groups.

Sponsors

Suzanne Broadbent
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Medical diagnosis of Chronic Fatigue Syndrome: persistent and disabling, and/or recurring, fatigue lasting for more than 6 months, that does not result from physical exertion and that is not alleviated by rest. Other symptoms include muscle weakness and pain, ongoing medical symptoms such as swollen lymph nodes and fever, poor sleep, poor concentration and reduced quality of life.

Exclusion criteria

Diagnosed cardiac and/or respiratory disease; joint or muscle condition/disease other than CFS, that is contraindicated for exercise; any mental health condition that may affect exercise participation or safety of participant and researchers.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 10, 2026