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Table 2 Assessments and instruments

From: Design of the EXercise Intervention after Stem cell Transplantation (EXIST) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of an individualized high intensity physical exercise program on fitness and fatigue in patients with multiple myeloma or (non-) Hodgkin's lymphoma treated with high dose chemotherapy and autologous stem cell transplantation

Outcome measures

Instrument

Primary

 

Cardiorespiratory fitness

Maximal exercise test.

Muscle strength

Maximum handgrip strength and 30 seconds chair stands test.

Fatigue

Multidimensional Fatigue Inventory (MFI) [50] and the Fatigue Quality List (FQL) [51] questionnaires.

Secondary

 

Body composition and bone mineral density

DXA-scans3 [55, 56] and physical examination; height, weight, waist and hip circumferences, four skinfolds (biceps, triceps, suprailiacal and subscapular).

Objective level of physical activity

Recordings of the Actitrainer accelerometer (Actigraph, Fort Walton Beach, USA).

Health-related quality of life

EORTC Quality of Life Questionnaire C30 (EORTC QLQ-C30) [57], the EORTC Myeloma Module (QLQ-MY20) [58].

Neuropathy3

EORTC Chemotherapy-induced peripheral neuropathy module (QLQ-CIPN20) [59].

Self reported physical activity

PASE questionnaire [60].

Mood disturbance

Hospital Anxiety and Depression Scale (HADS) questionnaire [61, 62].

Functioning in daily life

Impact on Participation and Autonomy (IPA) questionnaire [63].

Return to work

Return to work questionnaire.

Cost questionnaires4

EuroQol (EQ5D) [54] and cost questionnaires.

Other

 

Sociodemographic data1

Age, education, marital status, living situation, co-morbidities and life style variables (e.g. smoking).

Medical history1

Date of diagnosis, subtype of disease, stage of disease, history of therapy will be recorded from medical records.

Disease status and treatment

Blood levels (incl. platelet and erythrocyte count), response to treatment, progression or relapse of disease and data on any additional treatment will be recorded from medical records.

Comorbidity

A questionnaire and at T = 0 a sports physician will examine comorbidities that might interfere with the intervention program or influence study outcome.

Adverse events

Medical records, reports of the sports physician and physiotherapist.

Potential predictors of compliance

Questionnaire about pre-illness lifestyle, current attitudes toward and beliefs about exercise in general.

Satisfaction with the intervention2

Satisfaction questionnaire; intervention arm only.

Compliance with the exercise program2

Self-report and objective measures (e.g. attendance, exercise logs, target intensity); intervention arm only.

  1. 1 assessment at T = 0 only
  2. 2 assessment at T = 1 only
  3. 3 assessment at T = 0, T = 2
  4. 4 monthly assessments between T = 0 and T = 1 and once every 3 months between T = 1 and T = 2