Comparative Effects of Traditional Moderate Intensity Training and High Intensity Interval Training on Anxiety, Fatigue and Quality of Life in Polycystic Ovarian Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)
Study Overview
Brief Summary
To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants with BMI greater than 25kg/m2
- •Oligo- or anovulation/irregular cycles i.e 35 days
- •Married women
- •Primary infertility
- •A diagnosis of polycystic ovaries based on ultrasound results
Exclusion Criteria
- •Use of psychiatric or psychotropic medications.
- •Unresolved gynecological conditions i.e Cervical Dysplasia, Pelvic floor prolapse, Uterine Fibroids, Urinary Incontinence
- •Diabetes, pregnancy, smoking, illness or injury that prevented or limited exercise performance and existing participation in regular physical activity
Outcomes
Primary Outcomes
The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)
Time Frame: 4th week
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function. All five PCOSQ dimensions were internally reliable with Cronbach's alpha scores ranging from 0.70 to 0.97. Intra-class correlation coefficients to evaluate test-retest reliability were high (range 0.89-0.95, P \< 0.001). All five PCOSQ dimensions were internally reliable with Cronbach's α scores ranging from 0.70 to 0.97. Construct validity was demonstrated by high correlations for PCOSQ (0.49 and 0.54)
The Fatigue Impact Scale (FIS)
Time Frame: 4th week
The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Daily Fatigue Impact Scale (D-FIS) consist of eight items that could be used for monitoring daily changes in fatigue. The test-retest reliability of FIS was good in terms of its cognitive, physical, and psychosocial subscales and total scores, with ICC values of 0.78, 0.73, 0.80, and 0.83, respectively
Hamilton Anxiety Rating scale (HAM-A)
Time Frame: 4th week
The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Although the HAM-A remains widely used as an outcome measure in clinical trials. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Reliability and concurrent validity of the HAM-A and its subscales were sufficient. The Cronbach's α of the Hamilton Anxiety Scale was 0.89
Secondary Outcomes
No secondary outcomes reported