NCT07750821

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress42%
Jan 2026May 2027

Study Start

First participant enrolled

January 27, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

July 28, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

B-PuReBalancePulmonary rehabilitationCOPD

Outcome Measures

Primary Outcomes (1)

  • Feasibility of study procedures and the delivery of S4S.

    The primary feasibility outcomes include participant recruitment rates per site, participants' willingness to be randomised, participant attrition rates, and participant adherence rates.

    Outcomes are assessed at the end of recruitment, post-randomisation, and approximately 12 weeks after baseline assessment

Study Arms (2)

Usual care

NO INTERVENTION

Participants randomised to this arm will continue with their home based exercise programme provided by pulmonary rehabilitation as part of usual care

Sport4Steadiness Programme

EXPERIMENTAL

A balance training programme post pulmonary rehabilitation

Other: Sport4Steadiness

Interventions

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 socialisation

Sport4Steadiness Programme

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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?

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Teesside University

Middlesbrough, TS1 3BX, United Kingdom

RECRUITING

South Tees Hospital Trust

Northallerton, DL6 1JG, United Kingdom

RECRUITING

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, TS198PE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Samantha Harrison, Professor

    Teesside University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Harrison, Professor

CONTACT

Alexandra Carne-Watson, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statisticians are partially blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A pilot feasibility, multi-centre, randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 6, 2026

Study Start

January 27, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 6, 2026

Record last verified: 2026-08

Locations