NCT06086847

Brief Summary

The purpose of this study is to compare the effects of progressive resistance training on physical state energy and fatigue during pregnancy. This study was a randomized controlled trial used to find the effects of progressive resistance training on physical state energy and fatigue during pregnancy. The data was collected from Sheikh Zaid Hospital via Visual analogue scale-fatigue, Numeric pain rating scale and Short form health survey-36. Sample size of 30 females was taken in 15 each group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 11, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

Energy stateFatiguePregnancyMuscle stretching exercises

Outcome Measures

Primary Outcomes (3)

  • Short Form Health survey (SF-36)

    Eight dimensions of health-related quality of life are measured using the 36-item Short Form Health Survey (SF-36). 36 items make up the questionnaire, which assesses physical functioning, role restrictions brought on by physical health, physiological discomfort, overall health status, vitality, social functioning, role limitations brought on by emotional issues, and mental health. A substantial body of research supports the reliability of the SF-36 measurements

    9 WEEKS

  • Numeric Pain Rating Scale(NPRS)

    The patient's level of pain is recorded by the NPRS (intensity of pain). Patients are asked to rate their current degree of pain on an 11-point scale with 0-3 representing mild pain, 4-6 representing moderate pain, and 7- 10 representing severe pain (Severe pain). Horizontal bars or lines are the standard format.

    9 WEEKS

  • Visual Analogue Scale-Fatigue(VAS-F)

    The scale has 18 components that are all related to one's perception of exhaustion. Each question asks respondents to place a "X" along a visual analogue line that runs between two extremes, such as "not at all fatigued" and "very tired," to indicate how they are feeling right now. Scores range from 0 to 100 due to the length of each line being 100 mm. Moreover, the instrument has two subscales: weariness (items 1-5, 11- 18), and energy (items 6-10)

    9 WEEKS

Study Arms (2)

Warm up Exercise + stretching Exercise + progressive resistance exercises

EXPERIMENTAL

* Group A (Experimental Group): * Warm up Exercise + stretching Exercise (upper and lower extremity) + progressive resistance exercises Warm up Exercise (for 5 min) Stretching (upper and lower extremity) 3\. Progressive Resistance exercises: 1. Leg press :( dual leg press): Leg press target the "Quadriceps" or quads .but they also work your "Hamstrings". 2. Leg curls (dual leg curls): Leg curls Target the "hamstrings" and "Calf" muscles Leg Extension The Muscles worked: 1. Rectus femoris 2. Vastus lateralis 3. Vastus medialis 4. Vastus intermedius 4\. Arm lat pull (dual arm lat pull): Back extension (lumber extension):

Other: progressive resistant exercises

warm up exercise + Stretching exercises

ACTIVE COMPARATOR

Warm up exercise (for 5 min) Stretching exercises (upper and lower extremity

Other: progressive resistant exercises

Interventions

Group A (Experimental Group): • Warm up Exercise + stretching Exercise (upper and lower extremity) + progressive resistance exercises Warm up Exercise (for 5 min) Stretching (upper and lower extremity) 3\. Progressive Resistance exercises: 1. Leg press :( dual leg press): Leg press target the "Quadriceps" or quads .but they also work your "Hamstrings". 2. Leg curls (dual leg curls): Leg curls Target the "hamstrings" and "Calf" muscles Leg Extension The Muscles worked: 1. Rectus femoris 2. Vastus lateralis 3. Vastus medialis 4. Vastus intermedius 4\. Arm lat pull (dual arm lat pull): Back extension (lumber extension):

Warm up Exercise + stretching Exercise + progressive resistance exerciseswarm up exercise + Stretching exercises

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy only occurs in females.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female with age of 20 to 40 years
  • Between 20-25 weeks of gestation.
  • Healthy individual
  • Pregnant females who are easily fatigued during activities of daily living.

You may not qualify if:

  • Those who reported regular resistance training exercises
  • Complicated pregnancy
  • Low pre-pregnancy body weight
  • Anemia
  • Diabetes
  • Psychiatric disorder
  • Orthopedic and cardiovascular limitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Hospital

Lahore, Punjab Province, 540000, Pakistan

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Faiza Taufiq, PPDPT

    Riphah International University, Senior Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

March 15, 2022

Primary Completion

February 15, 2023

Study Completion

May 15, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations