Pregnancy RelatedNCT06086847
Effects of Progressive Resistance Training on Physical State Energy and Fatigue During Pregnancy.
A study testing progressive resistant exercises in people with Pregnancy Related, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- progressive resistant exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • Those who reported regular resistance training exercises
- Complicated pregnancy
- Low pre-pregnancy body weight
- Anemia
- Diabetes
- Psychiatric disorder
- Orthopedic and cardiovascular limitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Progressive Resistance Training on Physical State Energy and Fatigue During Pregnancy
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.
Read the detailed description
According to the findings of a study on physical activity during pregnancy in 2021, obese women, who exercise less than ladies of normal body weight may gain from gradually increasing their amount of exercise to reduce the amount of weight gain associated with pregnancy. Exercise during pregnancy was consistently associated positively with sob-R among the women in both categories, which denotes that it may have an impact on the control of lepton activity and pregnancy-induced insulin resistance. Overall, our research suggests that obese women, who are lepton-resistant and at pregnant women at high risk of gestational diabetes, fast weight gain, and increased fetal adiposity should receive advice and supportive services to raise their activity level, with an emphasis on the fact that even slight improvements in action can be good for both child and maternal health.
- Conditions
- Pregnancy Related
- Being tested
- progressive resistant exercises
- Keywords
- Energy state, Fatigue, Pregnancy, Muscle stretching exercises
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive resistant exercisesOther
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)
- Progressive Resistance exercises:
- Leg press :( dual leg press): Leg press target the "Quadriceps" or quads .but they also work your "Hamstrings".
- Leg curls (dual leg curls):
Leg curls Target the "hamstrings" and "Calf" muscles Leg Extension
The Muscles worked:
- Rectus femoris
- Vastus lateralis
- Vastus medialis
- Vastus intermedius
- Arm lat pull (dual arm lat pull):
Back extension (lumber extension):
| Study group | Role | What they receive |
|---|---|---|
| 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): Receives: Other: progressive resistant exercises |
| warm up exercise + Stretching exercises | Active comparator | Warm up exercise (for 5 min)
Stretching exercises (upper and lower extremity Receives: Other: progressive resistant exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: 9 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start15 Mar 2022
- Primary completion15 Feb 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, PPDPT, Principal investigator, Riphah International University, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086847
- Sponsor's protocol ID
- REC/RCR&AHS/22/0530
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Resistance Training on Physical State Energy and Fatigue During Pregnancy
- ClinicalTrials.gov ID
- NCT06086847
- Acronym / sponsor ID
- REC/RCR&AHS/22/0530
- Conditions
- Pregnancy Related
- Keywords
- Energy state, Fatigue, Pregnancy, Muscle stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
According to the findings of a study on physical activity during pregnancy in 2021, obese women, who exercise less than ladies of normal body weight may gain from gradually increasing their amount of exercise to reduce the amount of weight gain associated with pregnancy. Exercise during pregnancy was consistently associated positively with sob-R among the women in both categories, which denotes that it may have an impact on the control of lepton activity and pregnancy-induced insulin resistance. Overall, our research suggests that obese women, who are lepton-resistant and at pregnant women at high risk of gestational diabetes, fast weight gain, and increased fetal adiposity should receive advice and supportive services to raise their activity level, with an emphasis on the fact that even slight improvements in action can be good for both child and maternal health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm up Exercise + stretching Exercise + progressive resistance exercises | Experimental | Other: progressive resistant exercises* 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 exercises | Active comparator | Other: progressive resistant exercisesWarm up exercise (for 5 min) Stretching exercises (upper and lower extremity |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- • Those who reported regular resistance training exercises
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive resistant exercisesGroup 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 | Warm up Exercise + stretching Exercise + progressive resistance exercises, warm up exercise + Stretching exercises |
Primary outcome
Short Form Health survey (SF-36)
Time frame: 9 WEEKS
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
Numeric Pain Rating Scale(NPRS)
Time frame: 9 WEEKS
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.
Visual Analogue Scale-Fatigue(VAS-F)
Time frame: 9 WEEKS
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faiza Taufiq, PPDPT principal investigator
Riphah International University, Senior Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive resistant exercises in people with Pregnancy Related, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health survey (SF-36) (time frame: 9 WEEKS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.