Skip to content

Exercise therapy and cognitive behavioural therapy in Postpoliomyelitis Syndrome: effects on fatigue, activities and quality of life.

Exercise therapy and cognitive behavioural therapy in Postpoliomyelitis Syndrome: effects on fatigue, activities and quality of life. - FACTS-2-PPS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35382
Enrollment
81
Registered
2008-09-22
Start date
2009-05-29
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Postpoliomyelitis Syndrome PPS

Interventions

The 81 patients will be randomized to one of three groups i.e. (1) exercise therapy + usual care, (2) CBT + usual care, (3) usual care.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) diagnosis of PPS according to the criteria of March and Dimes i.e. a. A confirmed history of paralytic poliomyelitis characterized by an acute illness with fever and a usually asymmetrically distributed, flaccid paresis of a varying number of muscle groups. Evidence of motor neuron loss on neurological examination with signs of residual weakness, atrophy, loss of tendon reflexes and intact sensation. b. A period of partial or complete functional recovery after acute paralytic poliomyelitis, followed by an interval (usually 15 years or more) of stable neurologic function. c. Gradual or sudden onset of progressive and persistent new muscle weakness or abnormal muscle fatigability (decreased endurance), with or without generalized fatigue, muscle atrophy, or muscle and joint pain. Symptoms persist for at least a year. d. No other medical diagnosis to explain the symptoms (anemia and thyroid dysfunction as a cause of fatigue will be ruled out by blood test). (2) suffering from severe perceived fatigue (CIS-fatigue >

Exclusion criteria

Exclusion criteria: (1) cognitive impairment (2) insufficient mastery of the Dutch language (3) pregnancy (4) use of psychotropic drugs (except simple sleeping medication) or other psychiatric treatment. (5) use of medication causing fatigue (6) disabling co-morbidity interfering with the intervention programs or influencing outcome parameters (including cardiopulmonary disease like chest pain, arrhythmia, pacemaker, cardiac surgery, severe dyspnoea d*effort or emphysema, epileptic seizures, poorly regulated diabetes mellitus). (7) respiratory insufficiency

Design outcomes

Primary

MeasureTime frame
At baseline, completion of the intervention and at 3- and 6-months follow-up, fatigue (Checklist Individual Strength, domain fatigue), limitations in activities (Sickness Impact Profile, domains: mobility range, mobility control, social behaviour), HRQoL (SF-36), and secondary outcome measures will be assessed.

Secondary

MeasureTime frame
Secundary outcome measures are pain, psychological well being, cardiorespiratory fitness, neuromuscular capacity, physical activity level in daily life, participation, functional capacity, self efficacy, illness cognitions, coping and resource use.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)