NCT06658548

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable lung disease. People with COPD must work harder to breathe, which can lead to shortness of breath and/or feeling tired. Early in the disease, people with COPD may feel short of breath when they exercise. As the disease progresses, it can be hard to breathe out (exhale) or even breathe in (inhale). A person with COPD may have obstructive bronchiolitis emphysema, or a combination of both conditions. There is variety of treatment like breathing exercises, inspiratory muscle training exercises, resistance training and aerobic exercise to improve lung function as well as to decrease the chances of cardiopulmonary complications. the purpose of this study it to observe the effects of hand gripping isometric exercises on pulmonary functions in COPD patients. Study design will be randomized clinical trial in which experiment group will receive isometric training with resistance training and other group will only receive resistance training . Total forty eight participates will recruited with convince sampling, after that we will use simple random sampling to divide the patient into both equal groups. Digital spirometry will be used to document the pulmonary function also to observe the difference in post treatment.Data analysis will be done using SPSS version 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

September 16, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

Pulmonary functionsHand grip strengthChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

  • 6 Minute Walk Test

    6MWT is a sub-maximal exercise test used to examine person aerobic capacity and endurance. This test initially developed to make an assessment of patient with cardiopulmonary issues. It is used to check the functional capacity of the individual and it provides useful information regarding all the body systems during physical activity, including cardiovascular and pulmonary system. It can used for all age group range 2 to above 64 years The test is easy to perfume , with standardized limited instructions and encouragement being given as person walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters.

    Baseline; 5th Week; 10th Week

  • Forced Vital Capacity (FVC)

    The FVC is the forced vital capacity. It requires that the subject make a maximal inspiration to TLC, then make a maximal forced expiratory effort, leaving only the RV. In a normal subject, the FEV1/FVC is greater than 0.8; patients with obstructive lung disease, such as asthma or COPD, show a decreased FEV1/FVC

    Baseline; 5th Week; 10th Week

  • Forced Expiratory Volume in 1 second (FEV1)

    Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. FEV1 values that are lower than average suggest the presence of COPD.

    Baseline; 5th Week; 10th Week

  • FEV1/FVC Ratio

    The FEV1/FVC ratio is a measurement of lung function that compares the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC). It is used to help diagnose and monitor lung conditions.

    Baseline; 5th Week; 10th Week

Study Arms (2)

Group A

EXPERIMENTAL
Other: Isometric handgrip exercise training with resistance exerciseOther: Resistance Exercise

Group B

ACTIVE COMPARATOR
Other: Resistance Exercise

Interventions

The subjects will perform 24 consecutive days, an isometric handgrip exercise at 30% Maximum Voluntary Contraction (M.V.C)continue the exercise protocol for another 48 consecutive days.

Group A

The subjects will undergo outpatient training intervention during a period of 8 weeks will be using a hypertrophic maximum strength training method, which will divided into three phases: (1) muscle habituation training (2 weeks), (2) hypertrophic training I (5 weeks), and (3) hypertrophic training II, with intensified eccentric work (5 weeks).

Group AGroup B

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range from 40 to 70 years
  • Clinical or functional diagnosis of COPD criteria GOLD II and III
  • Clinically stable (outside the period of exacerbation of the disease for at least 3 months),
  • Independently able to perform instrumental activities of daily living, as assessed by the functional activities questionnaire
  • No medical contraindications for physical exercise

You may not qualify if:

  • Pulmonary diseases such as asthma, pulmonary fibrosis, pneumonia and other non-pulmonary
  • Sever or difficult to control ( heart disease or sequelae of acute or chronic orthopedic and/or neurological diseases),
  • Those who use walking assist devices that could influence the exercise
  • Enrolled in a physical training program within the last 3 months at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Fonseca J, Machado FVC, Santin LC, Andrello AC, Schneider LP, Fernandes Belo L, Rodrigues A, Fernandes Rugila D, Furlanetto KC, Hernandes NA, Pitta F. Handgrip Strength as a Reflection of General Muscle Strength in Chronic Obstructive Pulmonary Disease. COPD. 2021 Jun;18(3):299-306. doi: 10.1080/15412555.2021.1919608. Epub 2021 May 7.

    PMID: 33961519BACKGROUND
  • Felipe C, Bartolome C, Miguel D, Victor PP. Longitudinal changes in handgrip strength, hyperinflation, and 6-minute walk distance in patients with COPD and a control group. Chest. 2015 Oct;148(4):986-994. doi: 10.1378/chest.14-2878.

    PMID: 25996450BACKGROUND
  • Lau CW, Leung SY, Wah SH, Yip CW, Wong WY, Chan KS. Effect on muscle strength after blood flow restriction resistance exercise in early in-patient rehabilitation of post-chronic obstructive pulmonary disease acute exacerbation, a single blinded, randomized controlled study. Chron Respir Dis. 2023 Jan-Dec;20:14799731231211845. doi: 10.1177/14799731231211845.

    PMID: 37976375BACKGROUND
  • Kovarik M, Joskova V, Patkova A, Koblizek V, Zadak Z, Hronek M. Hand grip endurance test relates to clinical state and prognosis in COPD patients better than 6-minute walk test distance. Int J Chron Obstruct Pulmon Dis. 2017 Dec 1;12:3429-3435. doi: 10.2147/COPD.S144566. eCollection 2017.

    PMID: 29238187BACKGROUND
  • Qiu P, Chen M, Lv S, Xie J, Wu J. The association between walking pace and hand grip strength with the risk of chronic obstructive pulmonary disease: a bidirectional Mendelian randomization study. BMC Pulm Med. 2023 Nov 20;23(1):450. doi: 10.1186/s12890-023-02759-z.

    PMID: 37986176BACKGROUND
  • Leong DP, Teo KK, Rangarajan S, Lopez-Jaramillo P, Avezum A Jr, Orlandini A, Seron P, Ahmed SH, Rosengren A, Kelishadi R, Rahman O, Swaminathan S, Iqbal R, Gupta R, Lear SA, Oguz A, Yusoff K, Zatonska K, Chifamba J, Igumbor E, Mohan V, Anjana RM, Gu H, Li W, Yusuf S; Prospective Urban Rural Epidemiology (PURE) Study investigators. Prognostic value of grip strength: findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet. 2015 Jul 18;386(9990):266-73. doi: 10.1016/S0140-6736(14)62000-6. Epub 2015 May 13.

    PMID: 25982160BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Danish Hassan, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2024

First Posted

October 26, 2024

Study Start

September 1, 2024

Primary Completion

December 30, 2024

Study Completion

February 28, 2025

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations