NCT05865145

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

Same day

First QC Date

April 5, 2023

Last Update Submit

May 17, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • Glucose level

    blood test that examines Glucose level in (mmol/L)

    4 weeks

  • calcium level

    blood test that examines calcium level in (mg/dL)

    4 weeks

  • sodium level

    blood test that examines sodium level in (mmol/L)

    4 weeks

  • potassium level

    blood test that examines potassium level in (millimol/L)

    4 weeks

  • carbon dioxide level

    blood test that examines carbon dioxide level in parts per million (ppm)

    4 weeks

  • chloride level

    blood test that examines chloride level in mmol/L

    4 weeks

  • blood urea nitrogen (BUN) level

    blood test that examines blood urea nitrogen (BUN) level in (mg/dL)

    4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

will receive High Intensity Interval Training program

Device: Electronic Bicycle Ergometer

Group B

EXPERIMENTAL

will receive Low Intensity Interval Training program

Device: Electronic Bicycle Ergometer

Interventions

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.

Group AGroup B

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • uncontrolled preexisting health conditions such as:
  • uncontrolled hypertension
  • uncontrolled diabetes
  • uncontrolled heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic faculty of physical therapy at Cairo University

Giza, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Rana H Elbanna, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer at faculty of physical therapy at Cairo University

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 18, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations