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B-FIT! A guideline to individualized exercise in post-polio syndrome

B-FIT! A guideline to individualized exercise in post-polio syndrome - B-FIT international

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49100
Enrollment
15
Registered
2019-08-08
Start date
2019-10-31
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-polio syndrome PPS

Interventions

Participants will receive a 4-month personalized physical training program according to the B-FIT training guidelines, with two low intensity and one high intensity trianing session a week.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (1) - prior paralytic poliomyelitis (confirmed by signs of residual weakness and atrophy of muscles on neuromuscular examination, or with EMG) with or without diagnosis of PPS (according to the March of Dimes criteria) (2) Presence of a question for help indicative of impaired physical fitness (3) Indication of physical inactivity (4) Ability to achieve a Borg score of 14 or higher during the incremental exercise test (5) Minimum age of 18 years

Exclusion criteria

Exclusion criteria: (1) Contraindication for exercise (based on the guidelines by the American College of Sports Medicine) (2) Unable to follow verbal or written instructions. (3) Insufficient mastery of the Dutch language. (4) Engaged in an exercise program for a period longer than 4 weeks during the last 6 months.

Design outcomes

Primary

MeasureTime frame
(1) Physical fitness The primary endpoint will be the difference in peak oxygen uptake before- and directly post-intervention.

Secondary

MeasureTime frame
(2) Patient and healthcare professional satisfaction An online survey will be developed to evaluate the patient and healthcare professional satisfaction with working according to the B-FIT aerobic training guidelines in the US and the Netherlands. The patient survey includes questions pertaining to the satisfaction with (1) the training program (e.g. feasibility, incorporation into daily life, intensity) and (2) the patient manual (e.g. clearness of instructions). The health care professional survey includes questions pertaining to the satisfaction with (1) the training program (e.g. possibility to use own clinical judgment and preferences), and (2) the therapist manual (e.g. clearness of instructions). Answers are rated on a 5-point Likert scale (1 = very poor, 5 = very good). (3) Daily activity Measured through heart rate monitoring during 7 consecutive days, to establish the total time spent in low, moderate and vigorous intensity activities. Activity monitors will be used to determine the total step count during the 7 day period and subjects will also be asked to keep an activity diary. (4) Perceived physical functioning Perceived physical functioning will be administered with the ACTIVLIM questionnaire. ACTIVLIM is a questionnaire on self-reported activity limitations that was validated using the Rasch model. The questionnaire consists of 22 daily activities of which the perceived difficulty in performing the activity is scored. (5) Health-related quality of life Assessed using the Short Form 36-item Health Survey (SF36). The physical health component scores and mental health component scores will be calculated. (6) Adherence Heart rate monitors will be used during training sessions to gain data that will be used to establish the total time that participants train within their prescribed individual heart rate zones.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)