NCT06377826

Brief Summary

the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 1, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 18, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 6 Minute Walk Test

    The six minute walk test 96 The six minute walking test (6MWT) was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6-minute walk test (6MWT) is commonly used to measure the functional exercise capacity in chronic patients with cardiovascular disease.

    8 weeks

  • The Beck Depression Inventory Scale

    The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts. Each question had a set of at least four possible responses, ranging in intensity. Higher total scores indicate more severe depressive symptom.

    8 weeks

  • SF- 36 SF-36

    SF- 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It comprises 36 questions that cover eight domains of health. The SF-36 is often used as a measure of a person or population's quality of life (QOL).

    8 weeks

Study Arms (3)

aerobic exercises

ACTIVE COMPARATOR

Aerobic exercises i-e treadmill walking, bicycle ergometer, Treadmill

Other: aerobic exercises

resistance training

EXPERIMENTAL

resistance exercise training gluteal bridge, calf raises, squats, seated shoulder press,

Other: resistance training

medication

PLACEBO COMPARATOR

only on drugs no exercise is given

Drug: medication

Interventions

group A will receive aerobic training like walking and cycling for 03 times per week approximately each exercise 5 to 10 minutes for 8 weeks.

aerobic exercises

this group will receive resistance training like gluteal bridge, calf raise, squats, seated shoulder press for 03 times per week approximately each exercise 5 to 10 minutes for 8 weeks.

resistance training

This group will be just on medication and no exercise will be given to this group

medication

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both males and females Age between 40 to 60 years Diagnosed cases of hypothyroidism Duration: 2 years being diagnosed Patients who easily perform exercises

You may not qualify if:

  • Patients with serious comorbidities like cancer Uncontrolled hypertension Vitally unstable patients Red flags for physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbottabad medical complex

Abbottābād, Khyber Pakhtunkhwa, 21300, Pakistan

RECRUITING

MeSH Terms

Interventions

ExerciseResistance TrainingDosage Forms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • saira jahan

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 22, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations