None listed
Conditions
Brief summary
The study will investigate the effectiveness of six months of self-paced aquatic exercise for individuals with CFS/ME, compared to usual care (control group). Outcome measures will include physical capacity (resting heart rate, resting blood pressure, oxygen saturation, perceived exertion (RPE), 6 minute walk test, hand grip strength, sit to stand test, sit and reach test, and the Apley's shoulder test); health and symptoms (full blood test with white cell differential, assessment of orthostatic blood pressure, FACIT fatigue and tiredness scale, and a VAS Pain scale); and quality of life (SF-36 Quality of Life; Hospital Anxiety and Depression Scale [HADS], surveys, and open-ended questions in interviews). Participants will be allocated to an exercise or control group, and supervised, self-paced exercise sessions will be held twice a week in a heated pool. The results will be applicable to all age groups who suffer CFS/ME, with or without FM. This is a proof-of-concept study with a view to conducting a larger, longitudinal trial to provide further evidence for clinical practice. It is hypothesized that (1) the aquatic exercise group will improve their exercise tolerance, physiological responses and quality of life, and reduce symptoms of fatigue, pain and anxiety compared to the control group; (2) the number of immune cells (leukocytes) will increase in the exercise group compared to the control group.
Interventions
Brief name: Self-paced Aquatic exercise
Materials: A climate-controlled pool with a temperature between 27°-30°, and aquatic exercise equipment (e.g. buoyancy belts, pool noodles, kick boards, water dumbbells etc.). Water resistant heart rate monitors and printed RPE scales for participants to rate their level of exertion.
Procedures: The exercise sessions will consist of:
1) A gentle 5-minute warm-up of range of motion exercises and stretches;
2) Approximately 10 – 15 minutes of low-intens
Brief name: Self-paced Aquatic exercise Materials: A climate-controlled pool with a temperature between 27°-30°, and aquatic exercise equipment (e.g. buoyancy belts, pool noodles, kick boards, water dumbbells etc.). Water resistant heart rate monitors and printed RPE scales for participants to rate their level of exertion. Procedures: The exercise sessions will consist of: 1) A gentle 5-minute warm-up of range of motion exercises and stretches; 2) Approximately 10 – 15 minutes of low-intensity aerobic, strength, balance and flexibility aquatic exercises. The duration may be progressed during the study if symptoms permit. 3) A gentle 5-minute cool-down of stretching. HR and RPE will be monitored before and after each session, and half-way through each session. Fatigue and tiredness will be recorded using a 0-10 Likert Scale after each session and 24- and 48-hr post-session. Participants will also be asked to keep a symptom and activity diary, with daily entries. Diaries will be collected at the end of each month, with responses collated for qualitative analysis. Who: the exercise intervention will be delivered by Accredited Clinical Exercise Physiologists (AEPs) with experience in the delivery of aquatic exercise and rehabilitation. They will also be assisted by a second AEP and/or exercise science students. Mode of delivery: The intervention will be delivered face to face and in a group setting. Number of times: Exercise sessions will take place 2 per week for the duration of 6 months. The duration of each session will be approximately 30 minutes (may vary depending on each participant's ability). Intensity: participants will pace themselves according to their ability and symptoms and will be rated by each individual's rate of perceived exertion. RPE will remain at <5 (0-10 Borg scale). Location: the intervention will take place in two regional sites and will occur at a publicly-accessibly pool which will be booked for the duration of the intervention. The same exercises will be provided to all individuals in the group with alternative suggestions/adaptations made for any individuals that might need it. Instructions on any adaptations will be provided by the clinical exercise physiologist delivering the exercise session. Adherence to the intervention will be assessed by the researchers (which includes the clinical exercise physiologists conducting the exercise sessions) by monitoring attendance as well as by the use of symptom and activity diaries which will be collected at the end of each month by the researchers. A follow-up text message or call will be made to those participants who missed an exercise session without notifying the researchers.
Sponsors
Southern Cross University
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 80 Years
Healthy volunteers
No
Inclusion criteria
(1) Age range of 18-80 years (2) GP diagnosis of CFS &/or ME, Post Viral Syndrome, Post Viral Fatigue Syndrome or Chronic Mononucleosis by means of the Canadian Consensus criteria or the Fukuda criteria (3) Does not currently participate in regular vigorous exercise or physical activity (4) Is able to communicate in English (5) Able to give informed, signed consent (6) Able to commit the time required for participating in this research
Exclusion criteria
(1) Cardiovascular condition that makes physical activity hazardous (2) Severe chronic obstructive pulmonary disease or uncontrolled asthma (3) A diagnosed medical condition other than CFS/ME which causes chronic or severe fatigue (4) Metabolic, renal, endocrine, autoimmune, neurological or inflammatory disease that makes physical activity hazardous (5) A current musculoskeletal injury that prevents physical activity (6) Mental illness that makes participation in this research hazardous (7) Infectious diseases (8) Non-swimmer (9) Allergic to chlorine or other pool chemicals (10) Pregnant
Outcome results
None listed