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COPDCOPDNCT05044884

Effects of Otago Exercise Program vs Circuit Training on Balance in Chronic Obstructive Pulmonary Disease Patients

A study testing Otago Exercise training and Circuit training in people with COPD, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is designed to compare circuit training and otago exercise program for improvement of balance in COPD patients. Although both techniques are effective for balance training but Otago exercise program is home-based exercise program, which, if proven effective, will help the COPD patients to do work up at home… Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
COPD
What is being tested?
Otago Exercise training and Circuit training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePakistan
Study dates
10 Sep 2021to 18 Jan 2022
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 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both male and female patients.
  • Patients with mild / moderate COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
  • Patients with fall history in the past 5 years.

Who cannot join

  • Oxygen-dependent or mechanically ventilated patients.
  • Patients with impaired hearing or cognition, (e.g., dementia or neurological condition)
  • Patients with limited balance and mobility owing musculoskeletal or neurological condition.
  • Patients with unstable cardiovascular disease.
  • Patients with intellectual disabilities.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Suman Sheraz

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

Official title: Effects of Otago Exercise Program vs Circuit Training on Balance in Chronic Obstructive Pulmonary Disease (COPD) Patients

The study is designed to compare circuit training and otago exercise program for improvement of balance in COPD patients. Although both techniques are effective for balance training but Otago exercise program is home-based exercise program, which, if proven effective, will help the COPD patients to do work up at home, thereby reducing cost of hospital visits and improving balance ability and thus the quality of life more effectively.

Read the detailed description

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that result in progressive restriction of airflow and respiratory distress and is the 4th leading cause of death. In specific, it happens among smokers over the age of 40 and individuals exposed to biomass smoke. The prevalence of COPD is expected to increase as the population ages. Pakistan is a lower-middle-income country, and facing a high burden of chronic obstructive pulmonary diseases. The prevalence of COPD among Pakistani adults aged more than 40 years is 2.1% In addition to pulmonary symptoms, patients with chronic obstructive pulmonary disease develop many other manifestations of the disease, such as cardiovascular co morbidities, peripheral muscle dysfunction, weight loss, systemic inflammation, and psychological problems. People also have reduced capacity for exercise and functional mobility. Among all, one important extra respiratory manifestation is impaired balance. It is a frequent problem in stable COPD and increases with the severity of the disease. As in COPD there is loss of body cells which causes skeletal muscle weakness and balance impairment.

Since skeletal muscle dysfunction in people with COPD is a commonly identified impairment, it is not surprising that lower-limb muscle weakness has also been linked in this population to balance deficits and increased risk of falling. Muscle strength in both the upper and lower extremities is reduced in COPD patients along with impairments in exercise tolerance.

Pulmonary rehabilitation (PR) is an effective COPD intervention that involves exercise training and psychosocial support, and patient education to achieve maximum community independence and function. This recommended standard of care, however, focuses primarily on training peripheral muscles through endurance and strength training and does not include a particular training component. The effective intervention to successfully reduce both the rate and risk of falling has been shown to be exercise with balance-specific training.

As COPD decreases the amount of physical activity, even early in the disease phase, and impairs the strength of the lower limb muscle thus affecting balance. Balance training protocols together with pulmonary rehabilitation exercises helps to improve balance and symptoms of COPD. Although both circuit training and Otago exercise program are effective for balance training but Otago exercise program is home-based exercise program, which, if proven effective, will help the COPD patients to do work up at home, thereby reducing cost of hospital visits and improving balance ability and thus the quality of life more effectively.

Conditions
COPD
Being tested
Otago Exercise training, Circuit training
Keywords
Chronic obstructive pulmonary disease (COPD), Pulmonary rehabilitation, Balance, Otago exercise, Circuit training
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otago Exercise trainingOther

    1. Warm-up exercises. Chair March, Arm swings ( 30 second), Head movement, neck movement, back extension, trunk movement, ankle movement (repeat 5 times). Back of thigh stretch, calf stretch, (hold for 8 seconds).
    2. Strengthening exercises Front knee strengthening, back knee strengthening, side hip strengthening (2 or more sets of 10 reps) Calf raises, toe raises (repeat this exercises 10 to 20 times)
    3. Balance improvement exercises Knee bends, heel-toe standing, heel toes walking, one leg stand ( start with 5 sec move up to 10 sec) Side walk, heel walking, sit to stand, backwards walking, heel toes walking backwards, walking and turning around, stair walking (10 steps).
    4. Cool-down session Back of thigh stretch, calf stretches ( 10 to 20 sec hold, 1 to 3 reps)
    5. Pulmonary rehabilitation program
    • Daily breathing exercises (e.g. diaphragmatic, pursed lip breathing).
    • Stretch exercise for major respiratory muscles.
  • Circuit trainingOther

    1. Functional strength exercises Heel raise, toe raise, walking on toes, step ups in all directions ( forward, backward and sideways) (2 sets and 8 reps)
    2. Stance exercises Tandem, narrow, one leg stance, and stand on uneven surfaces with open eyes (each exercise 30 seconds) Tandem, narrow, one leg stance, and stand on uneven surfaces with eyes closed (each exercise 15seconds).
    3. Transition exercises Sit to stand from chair with arms (10 reps) and then without arms support (5 reps). Sit on floor and stand up with assistance and then without assistance.
    4. Gait training Walking tandem, sideway and backward with arm support. Walking tandem, sideway and backward without arm support Walking tandem, sideway and backward over obstacles
    5. Pulmonary rehabilitation program
    • Daily breathing exercises (e.g. diaphragmatic, pursed lip breathing).
    • Stretch exercise for major respiratory muscles
Study groups in NCT05044884
Study groupRoleWhat they receive
Otago exercise groupExperimentalThe Otago exercise group will practice the Otago exercise protocol which includes strength and balance exercises along with pulmonary rehabilitation. * 3 times per week for 8 weeks. * Each session will be of 60 minutes * Total number of sessions: 24
Receives: Other: Otago Exercise training
Circuit training groupActive comparatorThe Circuit training group will practice balance exercises including Stance exercise, Functional strength exercise, Transition exercise and Gait training along with pulmonary rehabilitation. * 3 times per week for 8 weeks. * Each session will be of 60 minutes * Total number of sessions: 24
Receives: Other: Circuit training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale

    Berg Balance Scale was originally developed to measure balance in the elderly, it has since been used to measure balance in a wide variety of patients. Each of these items is scored from 0 to 4, which are summed to make a total score between 0 and 56, with a higher score indicating better balance. The relative intrarater reliability of the Berg Balance Scale is 0.98 (0.97 to 0.99). Relative inter-rater reliability is 0.97 (0.96 to 0.98). Changes in berg balance scale from baseline to 4th and after 8 weeks of intervention will be assessed.

    Measured: 8 weeks

  2. Unipedal Stance (UPST) test

    The Unipedal stance test is described as a method of quantifying static balance ability and is useful in explaining other variables of importance such as frailty and self-sufficiency in activities of daily living, gait performance, and fall status. It can be used in a variety of settings and requires minimal equipment or training. It is a valid measure. Abnormal unipedal stance test (UPST) time with the eyes open is related to conditions such as peripheral neuropathy and intermittent claudication. Decreased eyes open UPST time is also associated with an increased risk for falls. Its inter-rater reliability was determined to be excellent with an intra-class correlation coefficient of 0.994(95% confidence interval 0.989-0.996) for eye open and 0.998 (95% confidence interval 0.996-0.999) for eye close. Average time of unipedal stance in healthy older adults is < 10 seconds. Changes in UPST from baseline to 4th and after 8 weeks of intervention will be assessed.

    Measured: 8 weeks

Secondary outcomes (5)
  1. St. George Respiratory questionnaire for quality of life (QOL)

    The most commonly used disease-specific quality of life measure for COPD patients is the St. George's Respiratory Questionnaire (SGRQ). Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.. It is divided in two parts. Part I produces the Symptoms score, and Part 2 the Activity and Impacts scores. The reliability coefficient was 0.94 for the overall scale and 0.72 for "Symptoms", 0.89 for "Activity", and 0.89 for "Impacts" subscales.

    A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment) Changes in St. George Respiratory questionnaire for quality of life from baseline to 4th and after 8 weeks of intervention will be assessed.

    Measured: 8 weeks

  2. Peak expiratory flow rate (PEFR)

    Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings. Changes in PEFR from baseline to 4th and after 8 weeks of intervention will be assessed.

    Measured: 8 weeks

  3. Forced vital capacity (FVC)

    Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 4th and after 8 weeks of intervention will be assessed.

    Measured: 8 weeks

  4. Forced expiratory volume in 1sec (FEV1)

    Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal. Changes in FEV1 from baseline to 4th and after 8 weeks of intervention will be assessed.

    Measured: 8 weeks

  5. FVC/FEV1

    FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65). Changes in FEV1/FVC from baseline to 4th and after 8 weeks of intervention will be assessed.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start10 Sep 2021
  3. Primary completion20 Dec 2021
  4. Study completion18 Jan 2022

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05044884
Sponsor's protocol ID
REC/00960 Saba Nadeem
Acronym
COPD
Status last verified
Jan 2022
First submitted
1 Sep 2021
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Crisan AF, Oancea C, Timar B, Fira-Mladinescu O, Tudorache V. Balance impairment in patients with COPD. PLoS One. 2015 Mar 13;10(3):e0120573. doi: 10.1371/journal.pone.0120573. eCollection 2015.

    PubMed 25768731
  • Beauchamp MK, Brooks D, Ellerton C, Lee A, Alison J, Camp PG, Dechman G, Haines K, Harrison SL, Holland AE, Marques A, Moineddin R, Skinner EH, Spencer L, Stickland MK, Xie F, Goldstein RS. Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Nov 20;6(11):e228. doi: 10.2196/resprot.8178.

    PubMed 29158206
  • de Castro LA, Ribeiro LR, Mesquita R, de Carvalho DR, Felcar JM, Merli MF, Fernandes KB, da Silva RA, Teixeira DC, Spruit MA, Pitta F, Probst VS. Static and Functional Balance in Individuals With COPD: Comparison With Healthy Controls and Differences According to Sex and Disease Severity. Respir Care. 2016 Nov;61(11):1488-1496. doi: 10.4187/respcare.04749. Epub 2016 Aug 2.

    PubMed 27484106
  • Porto EF, Castro AA, Schmidt VG, Rabelo HM, Kumpel C, Nascimento OA, Jardim JR. Postural control in chronic obstructive pulmonary disease: a systematic review. Int J Chron Obstruct Pulmon Dis. 2015 Jun 29;10:1233-9. doi: 10.2147/COPD.S63955. eCollection 2015.

    PubMed 26170652
  • Marques A, Jacome C, Cruz J, Gabriel R, Figueiredo D. Effects of a pulmonary rehabilitation program with balance training on patients with COPD. J Cardiopulm Rehabil Prev. 2015 Mar-Apr;35(2):154-8. doi: 10.1097/HCR.0000000000000097.

    PubMed 25517104
  • Dadgari A, Aizan Hamid T, Hakim MN, Chaman R, Mousavi SA, Poh Hin L, Dadvar L. Randomized Control Trials on Otago Exercise Program (OEP) to Reduce Falls Among Elderly Community Dwellers in Shahroud, Iran. Iran Red Crescent Med J. 2016 Feb 14;18(5):e26340. doi: 10.5812/ircmj.26340. eCollection 2016 May.

    PubMed 27478629

Questions about this trial

What is this clinical trial studying?

A study testing Otago Exercise training and Circuit training in people with COPD, 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 3 inclusion and 5 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 26 Jan 2022. 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?

Berg Balance Scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05044884, which also lists 6 linked publications.

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 26 Jan 2022.

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