- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06658548
Isometric Hand Grip Exercise and Lung Function in COPD
Effects of Isometric Hand Grip Exercise Training on Lung Function in COPD Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The most common respiratory symptoms associated with COPD include dyspnea, cough and/or sputum production. In addition to the daily symptom burden, COPD may be punctuated by periods of acute worsening of respiratory symptoms (often referred to as 'exacerbations'), which account for the greatest proportion of total COPD burden on healthcare systems. COPD can be progressive, as indicated by reductions in spirometry measures such as forced expiratory volume in 1 s (FEV1) over time, though patients may progress at different rates.
Physical exercise is a major component of the total therapeutic regimen in pulmonary rehabilitation and has been positively correlated with better lung function in all age groups. Physical activity may attenuate age-related decline in pulmonary function and should be an integral part of pulmonary rehabilitation to improve lung function. Respiratory diseases constitute a major socioeconomic and a massive health burden all over the world. It represents an enormous drain on human and financial resources, and also contributes largely to morbidity and mortality at both global and national scales.
Age related decline in pulmonary function even in the absence of extrinsic pollutants, which can be caused by several factors related to the lung tissue itself. This age related decline further causes a reduction in exercise capacity and contributes immensely to loss of muscle power and mobility with progressive airflow limitation. The reduction in muscle power and increased airflow limitation contribute to the loss of muscle mass, decreased functional capacity and eventually loss of independence .Handgrip exercises are easy to perform, take less space and are more accessible in various locations such as hospitals, schools, in transit and in the home; therefore, it can lead to increased adherence to treatment.
A good number of scientific studies clearly demonstrate that isometric exercise is efficacious in the attenuation of resting blood pressure in both normotensive and hypertensive subjects. Isometric exercise produced greater reductions in systolic and diastolic blood pressure compared to dynamic exercise training. Moreover, physical exercise has been shown to be a non-pharmacological prophylactic regimen as it is capable of protecting against decline in pulmonary functions due to aging and enhances the physiological responses of the lungs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah Rehabilitation Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A
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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.
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).
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Active Comparator: Group B
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 Minute Walk Test
Time Frame: Baseline; 5th Week; 10th Week
|
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.
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Baseline; 5th Week; 10th Week
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Forced Vital Capacity (FVC)
Time Frame: Baseline; 5th Week; 10th Week
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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
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Baseline; 5th Week; 10th Week
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Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Baseline; 5th Week; 10th Week
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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.
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Baseline; 5th Week; 10th Week
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FEV1/FVC Ratio
Time Frame: Baseline; 5th Week; 10th Week
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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.
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Baseline; 5th Week; 10th Week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Danish Hassan, PhD*, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hajra Qazi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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