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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05865145
Other study ID # DR Rana
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2023
Est. completion date May 2023

Study information

Verified date May 2023
Source Cairo University
Contact Rana H Elbanna, PHD
Phone 01062070686
Email rana.hesham@pt.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants were randomly assigned to two groups prior to their second visit: the High intensity interval training group A (HIIT) and Low intensity interval training group B (LIIT). The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Group A will receive a program of high intensity interval training program Group B will receive a program of Low intensity interval training program


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 2023
Est. primary completion date May 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - could stand and walk for 30m without becoming out of breath. - could walk safely without the aid of another person. - body mass index (BMI) = 30 kg/m2 Exclusion Criteria: - uncontrolled preexisting health conditions such as: - uncontrolled hypertension - uncontrolled diabetes - uncontrolled heart disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electronic Bicycle Ergometer
Electronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be adjusted for High or Low interval intensity training.

Locations

Country Name City State
Egypt Outpatient clinic faculty of physical therapy at Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Rana Elbanna

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Exertion The Modified Borg Dyspnea Scale was used to assess perceived exertion during breathing. It was given after the first and final training sessions. The participants were asked to score their difficulty in breathing on a scale of 0 to 10, with 0 indicating no trouble in breathing at all and 10 indicating maximum difficulty in breathing 4 weeks
Primary Exercise Adherence The Exercise Adherence Rating Scale (EARS) is a self-reported 16-item questionnaire that rates adherence to prescribed workouts. The EARS are divided into three components. The suggested exercise questionnaire is discussed in Section (A), Section (B) discusses exercise adherence behavior, and Section (C) discusses the factors for exercise adherence/non-adherence. All items in sections B and C are rated on a 5-point Likert scale (0 = fully agree to 4 = entirely disagree). Section 'B' favourably phrased items (items 1, 4, and 6) and Section 'C' positively phrased items (items 4, 5, 6, and 7) are assessed in reverse order. Sections "B" and "C" have possible total scores ranging from 0 to 24 and 0 to 40, respectively. The potential total score for parts (B) and (C) is 64. A higher total score suggests more adherence to exercise. 4 weeks
Primary Glucose level blood test that examines Glucose level in (mmol/L) 4 weeks
Primary calcium level blood test that examines calcium level in (mg/dL) 4 weeks
Primary sodium level blood test that examines sodium level in (mmol/L) 4 weeks
Primary potassium level blood test that examines potassium level in (millimol/L) 4 weeks
Primary carbon dioxide level blood test that examines carbon dioxide level in parts per million (ppm) 4 weeks
Primary chloride level blood test that examines chloride level in mmol/L 4 weeks
Primary blood urea nitrogen (BUN) level blood test that examines blood urea nitrogen (BUN) level in (mg/dL) 4 weeks
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