NCT05044884

Brief 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, thereby reducing cost of hospital visits and improving balance ability and thus the quality of life more effectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 1, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

September 1, 2021

Last Update Submit

January 24, 2022

Conditions

Keywords

Chronic obstructive pulmonary disease (COPD)Pulmonary rehabilitationBalanceOtago exerciseCircuit training

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks

  • 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.

    8 weeks

Secondary Outcomes (5)

  • St. George Respiratory questionnaire for quality of life (QOL)

    8 weeks

  • Peak expiratory flow rate (PEFR)

    8 weeks

  • Forced vital capacity (FVC)

    8 weeks

  • Forced expiratory volume in 1sec (FEV1)

    8 weeks

  • FVC/FEV1

    8 weeks

Study Arms (2)

Otago exercise group

EXPERIMENTAL

The 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

Other: Otago Exercise training

Circuit training group

ACTIVE COMPARATOR

The 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

Other: Circuit training

Interventions

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.

Otago exercise group

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

Circuit training group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suman Sheraz

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 25768731BACKGROUND
  • 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.

    PMID: 29158206BACKGROUND
  • 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.

    PMID: 27484106BACKGROUND
  • 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.

    PMID: 26170652BACKGROUND
  • 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.

    PMID: 25517104BACKGROUND
  • 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.

    PMID: 27478629BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 16, 2021

Study Start

September 10, 2021

Primary Completion

December 20, 2021

Study Completion

January 18, 2022

Last Updated

January 26, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations