The Effect of Hospital Fit 2.0 on Patients Physical Activity

NCT04797130 | Completed DMC

• 1 other identifier: NL75126.068.20
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate if using Hospital Fit 2.0 as part of the usual care physiotherapy treatment of patients hospitalised at the department of Internal Medicine and the department of Pulmonology in MUMC+ will result in an increase in the amount of PA performed compared to patients who do not use Hospital Fit 2.0 as part of the physiotherapy treatment.

Conditions

Telemedicine; Internal Medicine; Pulmonary Disease

Keywords

Physical activity; eHealth; Accelerometer; Hospitalization

Outcome Measures

Primary Outcomes (1)

• Time spent walking per day (min.)

  Defined as the total number of minutes walking per day.

  Period between inclusion and discharge, with a maximum of seven days

Secondary Outcomes (10)

• Average time spent walking

  Period between inclusion and discharge, with a maximum of seven days

• Time spent standing per day (min.)

  Period between inclusion and discharge, with a maximum of seven days

• Average time spent standing

  Period between inclusion and discharge, with a maximum of seven days

• Number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking) per day

  Period between inclusion and discharge, with a maximum of seven days

• Average number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking)

  Period between inclusion and discharge, with a maximum of seven days

Study Arms (2)

Control group

NO INTERVENTION

All subjects eligible for inclusion in this study receive usual care physiotherapy as prescribed by the physician. The number of treatment sessions and content of physiotherapy treatment sessions will depend on the diagnosis and needs of the individual patient. This study will not interfere with the content of the usual care physiotherapy treatment. Patients in the control group will receive an accelerometer, measuring PA, which is applied by the physiotherapist during the first treatment. They receive no other additional intervention. Usual care physiotherapy sessions will take approximately 20-30 minutes per session.

Intervention group

EXPERIMENTAL

Patients in the intervention group will receive usual care physiotherapy and use Hospital Fit 2.0 (HF) additionally. After the last treatment session (max. 7 days), the therapist will remove the accelerometer and participation in the study will end.

Device: Hospital Fit 2.0

Interventions

Hospital Fit 2.0 DEVICE

HF consists of a smartphone app combined to an accelerometer. HF provides patients and physiotherapists direct feedback on patients' physical activity behavior.. Individual goals regarding the number of minutes per day spent walking can be set by the therapist. HF also shows patients insight into their own recovery progress. During every treatment, the physiotherapist will evaluate the extent of functional recovery. In addition, Hospital Fit will give physiotherapists the option of creating a patient-specific exercise program supported by videos. During every treatment session, the patient and physiotherapist will evaluate (and if necessary adapt) the amount of activity performed since the previous treatment, the extent of functional recovery and the exercise program.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years
• Receiving physiotherapy while hospitalised at the department of Internal Medicine department or the department of Pulmonology at the Maastricht University Medical Centre (MUMC+)
• Sufficient understanding of the Dutch language
• Having access to a smartphone
• Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC \>3)

You may not qualify if:

• A contraindication to walking (as reported by the attending medical specialists in the medical record)
• A contraindication to wearing an accelerometer, fixed by a hypoallergenic plaster at the upper leg (such as active bilateral upper leg infection, severe edema or bilateral transfemoral amputation)
• Admission at the intensive care department
• Impaired cognition (delirium / dementia) as reported by the attending doctor
• Incapacitated subjects as reported by the attending medical specialist in the medical record. When any doubt arises, the patient will not be considered eligible
• A life expectancy shorter than 3 months as mentioned by the attending medical specialist in the medical record
• Previous participation in this study

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MaastrichtUMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Lung Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Behavior

Study Officials

• Antoine F Lenssen, Prof, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors are blinded for treatment (control group: usual care physiotherapy treatment versus intervention group: usual care physiotherapy treatment and Hospital Fit 2.0 use)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: March 23, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)