Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sport4Steadiness.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), COPD, Balance Exercise, Falls, Intervention. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Feasibility, Multi-centre, Randomised Controlled Trial of Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)
Overview
This study aims to see if a co-designed balance training programme called Sport4Steadiness (S4S), is acceptable to people with COPD and if the study procedures, including recruitment and the collection of outcomes, is feasible.
Interventions
- Other Sport4Steadiness
Sport4Steadiness (S4S), is a group, exercise based, balance training programme. It was designed by researchers interested in balance in people with COPD and patients and members of the public who have, or care for someone with, COPD or other lung conditions. It adapts parts of different sports, games and activities to train balance and have fun. S4S sessions take place twice a week for 6 weeks, 12 sessions in total. Each session lasts for 2 hours with 1 hour of activity and 1 hour of socialisati
Primary outcome measures
- Feasibility of study procedures and the delivery of S4S. [Time frame: Outcomes are assessed at the end of recruitment, post-randomisation, and approximately 12 weeks after baseline assessment]
Eligibility criteria
Inclusion criteria
- Adults with spirometry confirmed diagnosis of COPD as per GOLD guidelines (FEV1/FVC ratio below 0.7) or physician confirmed COPD diagnosis
- Answers yes to one or more of the Three Key Questions\* or Timed up and Go Test result > 11 seconds
- An ability and capacity to provide consent to the trial
- Q1. Have you fallen in the past year? Q2. Do you feel unsteady when standing or walking? Q3. Do you have worries about falling?
Exclusion criteria
- Any neurological, musculoskeletal, chronic pain or other diagnoses that, in the opinion of the investigator, would interfere with the ability of the participant to safely complete PR and balance training
- Unable to comprehend instruction given verbally in English language
- Where there is concern that the primary cause of balance issues could be due to problems with visual function, vestibular disturbance or peripheral neuropathy
- Diagnosis of, or patient-reported symptoms of, vasovagal syncope
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United Kingdom · 3 centers
- Teesside University — Middlesbrough
- South Tees Hospital Trust — Northallerton
- North Tees and Hartlepool NHS Foundation Trust — Stockton-on-Tees
Identifiers
NCT: NCT07750821 · 358711 · 26932